Propofol vs Propofol + Benzo/Opiates in High Risk Group

Sponsor
Washington University School of Medicine (Other)
Overall Status
Terminated
CT.gov ID
NCT01315158
Collaborator
(none)
36
1
2
42
0.9

Study Details

Study Description

Brief Summary

This will be a randomized controlled trial that compares the rates of sedation related complications in high risk patients (ASA greater or equal to 3, BMI greater or equal to 30, those at risk for OSA) undergoing advanced endoscopy procedures with propofol alone compared to propofol in combination with benzodiazepines and opioids.

Condition or Disease Intervention/Treatment Phase
N/A

Detailed Description

The use of propofol (2,6-di-isopropofol) for sedation during endoscopic procedures has increased in recent years primarily because of its favorable pharmacokinetic profile compared with traditional endoscopic sedation with benzodiazepines and opioids. Propofol has a rapid onset of action (30-45 sec) and short duration of effect (4-8 min). There also are data to support the safe use of propofol for advanced endoscopic procedures such as endoscopic retrograde cholangiopancreatography (ERCP) and endoscopic ultrasound (EUS).

There is limited information on the incidence of sedation related complications during advanced endoscopy. Prior studies were limited by controlled patient populations at low risk of developing sedation related cardiopulmonary complications. In a recent study, we defined the frequency of sedation related adverse events including the rate of airway modifications (AMs) with propofol use during advanced endoscopy. From a total of 799 patients, AMs were required in 14.4% of patients, hypoxemia in 12.8%, hypotension in 0.5% and premature termination in 0.6% of the patients. In addition, body mass index (BMI), male sex and American Society of Anesthesiologists (ASA) class of 3 or higher were independent predictors of AMs. Similarly, Wehrmann and Riphaus identified ASA class of 3 or higher, total propofol dose, history of alcohol use and having an emergency endoscopy as independent factors for sedation related complications in patients undergoing advanced procedures.

Given the alarming rates of obesity in the United States, it is believed that the prevalence of obstructive sleep apnea (OSA) may be 10% or higher and in obese adults these numbers could be as high as 25%. Using a previously validated screening tool for OSA [STOP-BANG (SB)], we reported a prevalence rate of patients at risk for OSA of 43.3% in patients undergoing advanced endoscopy procedures. Patients at risk for OSA with a positive SB score (score ≥ 3 of 8) had a higher rate of AMs (20% vs. 6.1%, adjusted relative risk 1.7) and frequency of hypoxemia (12% vs. 5.2%, adjusted relative risk 1.63) compared to those at low risk for OSA. Thus, based on the available data, it appears that ASA class 3 or higher, high BMI, and patients at risk for OSA are factors that place patients undergoing advanced endoscopy procedures at high risk for sedation related complications including airway modifications.

The optimal method for achieving deep sedation in this high risk group of patients is unclear. Propofol may accentuate airway collapse as patients become unresponsive to verbal stimulation (deep sedation). Recent studies suggest that propofol with midazolam and/or opioids may be synergistic in action and therefore the combined application of these drugs may permit smaller doses of each to be used and potentially lead to a reduction in risk of complications and in the dose of propofol needed while retaining the individual advantages of each compound. There is limited data evaluating the synergistic effect of propofol with midazolam and opioids in patients undergoing advanced endoscopy procedures. Ong and colleagues in a randomized controlled trial compared patient sedation and tolerance during ERCP using propofol alone or midazolam, ketamine and pentazocine (sedato-analgesic cocktail) for induction along with propofol for maintenance. Patient tolerance as assessed by visual analog scales by endoscopist and anesthetist were higher in the combination group. Paspatis et al reported higher dosage of intravenous propofol required in patients being sedated with propofol alone compared with that required in patients receiving oral dose of midazolam with propofol for ERCP procedures. In addition, the patients' anxiety levels before the procedure were lower in the combination group. The mean percentage decline in the oxygen saturation during the procedure was significantly greater in propofol alone group. However, these studies excluded patients deemed to be at a high risk for sedation related complications. Patients with ASA class 3 or higher were excluded, the mean BMI was less than 25, and included only patients at average risk for complications associated with sedation.

The significance of synergistic sedation in patients undergoing advanced endoscopy procedures in the high risk patients is unclear. The overall risk of sedation related complications is thought to be higher compared to standard endoscopy due to longer procedure times and the need for relatively deeper levels of sedation.

Study Design

Study Type:
Interventional
Actual Enrollment :
36 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Incidence of Sedation Related Complications With Propofol Alone Versus Propofol With Benzodiazepines and Opiates in a High Risk Group Undergoing Advanced Endoscopic Procedures: A Randomized Controlled Trial
Study Start Date :
Jan 1, 2011
Actual Primary Completion Date :
Jul 1, 2014
Actual Study Completion Date :
Jul 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Propofol+Benzo/Opioids

If the patient is randomized into this arm the recommended Versed and Fentanyl doses are standardized: Recommended Versed: a. Prior to intubation patient is < 50 kg = 1 mg Versed patient is 50-75 kg = 1.5 mg Versed patient is > 75 kg = 2 mg Versed Recommended Fentanyl Prior to intubation = 0.5 ug/kg Total procedural dose = 1 ug/kg

Drug: Propofol+Benzo/Opioids
Recommended Versed: a. Prior to intubation patient is < 50 kg = 1 mg Versed patient is 50-75 kg = 1.5 mg Versed patient is > 75 kg = 2 mg Versed Recommended Fentanyl Prior to intubation = 0.5 ug/kg Total procedural dose = 1 ug/kg
Other Names:
  • Benzodiazepine
  • Midazolam
  • Versed
  • Opioid
  • Fentanyl
  • Active Comparator: Propofol Alone

    The patients randomized into the sedation with propofol alone are able to cross over if they are unable to be successfully sedated under propofol alone. The the recommended doses before considering crossover are standardized: Induction Dose: 2-2.5 mg/kg Maintenance Dose: 0.1-0.2 mg/kg/min

    Drug: Propofol Alone
    Recommended Propofol doses before considering crossover: Induction: 2-2.5 mg/kg Maintenance: 0.1-0.2 mg/kg/min
    Other Names:
  • Propofol
  • Diprivan
  • 2,6-di-isopropofol
  • Outcome Measures

    Primary Outcome Measures

    1. Number of Participants Who Experience Airway Maneuvers [One day (during procedure)]

      In high risk patients (meeting at least of 1 of 3 criteria: ASA ≥ 3, BMI ≥ 30, those at risk for OSA) undergoing advanced endoscopy procedures, compare the number of participants who experience airway maneuvers (AMs) when sedated with propofol alone versus propofol in combination with benzodiazepines and opioids.

    Secondary Outcome Measures

    1. Number of Participants Who Experience Other Sedation Related Complications [One day (during procedure)]

      Compare the number of participants who experience other sedation related complications such as hypotension, hypoxemia and need for termination of the procedure between the two groups

    2. Compare Propofol Doses Between the Two Groups [One day (during procedure)]

      The dose of propofol used between the two groups will be compared

    3. Predictors of Sedation Related Complications as Measured by the Number of Participants Who Experience Hypoxemia (Defined as a Pulse Oximetry <90% for Any Duration) [One year]

    4. Predictors of Sedation Related Complications as Measured by Hypopnea/Apnea (Defined as Fewer Than 6 Breaths/Minute Based on Capnography) [One year]

    5. Predictors of Sedation Related Complications as Measured by the Incidences of Hypotension (Defined as Systolic Blood Pressure of Less Than 90mmHg or a Decrease of More Than 25% From Baseline) [One year]

    6. Predictors of Sedation Related Complications as Measured by Early Procedure Termination for an Alternative Sedation Related Complication [One year]

    7. Patient Tolerance as Assessed by Endoscopists [24-48 hours]

      The frequency of symptoms of nausea and vomiting in the two groups of patients will be recorded. Patient tolerance of the procedure will be assessed independently by the endoscopist using a 100-mm visual analog scale (VAS, 0=unmanageable, 100=excellent). The patient will also score the level of tolerance using the same VAS at a routine follow-up phone call made 24-48 hours after the procedure.

    8. Number of Participants Who Experience Symptoms of Nausea and Vomiting Will be Compared Between the Two Groups [24-48 hours]

      The number of participants who experience symptoms of nausea and vomiting in the two groups of patients will be recorded. This will be recorded during the follow-up phone call made 24-48 hours after the procedure.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Ability to provide informed consent

    • Age greater than or equal to 18 years

    • Presence of at least 1 of the following criteria:

    1. ASA class 3 or higher

    2. BMI of 30 or greater

    3. At risk for OSA (score of 3 or greater on the STOP-BANG screening tool)

    Exclusion Criteria:
    • drug allergy to Propofol, Benzodiazepines, or Opioids

    • patients who received Benzodiazepines or Opioids within 24 hours of the procedure

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Washington University School of Medicine St. Louis Missouri United States 63110

    Sponsors and Collaborators

    • Washington University School of Medicine

    Investigators

    • Principal Investigator: Faris Murad, M.D., Washington University School of Medicine

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Washington University School of Medicine
    ClinicalTrials.gov Identifier:
    NCT01315158
    Other Study ID Numbers:
    • 10-1133
    First Posted:
    Mar 15, 2011
    Last Update Posted:
    Oct 28, 2016
    Last Verified:
    Sep 1, 2016
    Keywords provided by Washington University School of Medicine
    Additional relevant MeSH terms:

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title Propofol+Benzo/Opioids Propofol Alone
    Arm/Group Description If the patient is randomized into this arm the recommended Versed and Fentanyl doses are standardized: Recommended Versed: a. Prior to intubation patient is < 50 kg = 1 mg Versed patient is 50-75 kg = 1.5 mg Versed patient is > 75 kg = 2 mg Versed Recommended Fentanyl Prior to intubation = 0.5 ug/kg Total procedural dose = 1 ug/kg Propofol+Benzo/Opioids: 1. Recommended Versed: a. Prior to intubation patient is < 50 kg = 1 mg Versed patient is 50-75 kg = 1.5 mg Versed patient is > 75 kg = 2 mg Versed 2. Recommended Fentanyl a. Prior to intubation = 0.5 ug/kg b. Total procedural dose = 1 ug/kg The patients randomized into the sedation with propofol alone are able to cross over if they are unable to be successfully sedated under propofol alone. The the recommended doses before considering crossover are standardized: Induction Dose: 2-2.5 mg/kg Maintenance Dose: 0.1-0.2 mg/kg/min Propofol Alone: Recommended Propofol doses before considering crossover: Induction: 2-2.5 mg/kg Maintenance: 0.1-0.2 mg/kg/min
    Period Title: Overall Study
    STARTED 17 19
    COMPLETED 17 19
    NOT COMPLETED 0 0

    Baseline Characteristics

    Arm/Group Title Propofol+Benzo/Opioids Propofol Alone Total
    Arm/Group Description If the patient is randomized into this arm the recommended Versed and Fentanyl doses are standardized: Recommended Versed: a. Prior to intubation patient is < 50 kg = 1 mg Versed patient is 50-75 kg = 1.5 mg Versed patient is > 75 kg = 2 mg Versed Recommended Fentanyl Prior to intubation = 0.5 ug/kg Total procedural dose = 1 ug/kg Propofol+Benzo/Opioids: 1. Recommended Versed: a. Prior to intubation patient is < 50 kg = 1 mg Versed patient is 50-75 kg = 1.5 mg Versed patient is > 75 kg = 2 mg Versed 2. Recommended Fentanyl a. Prior to intubation = 0.5 ug/kg b. Total procedural dose = 1 ug/kg The patients randomized into the sedation with propofol alone are able to cross over if they are unable to be successfully sedated under propofol alone. The the recommended doses before considering crossover are standardized: Induction Dose: 2-2.5 mg/kg Maintenance Dose: 0.1-0.2 mg/kg/min Propofol Alone: Recommended Propofol doses before considering crossover: Induction: 2-2.5 mg/kg Maintenance: 0.1-0.2 mg/kg/min Total of all reporting groups
    Overall Participants 17 19 36
    Age (Count of Participants)
    <=18 years
    0
    0%
    0
    0%
    0
    0%
    Between 18 and 65 years
    15
    88.2%
    14
    73.7%
    29
    80.6%
    >=65 years
    2
    11.8%
    5
    26.3%
    7
    19.4%
    Sex: Female, Male (Count of Participants)
    Female
    9
    52.9%
    5
    26.3%
    14
    38.9%
    Male
    8
    47.1%
    14
    73.7%
    22
    61.1%
    Region of Enrollment (participants) [Number]
    United States
    17
    100%
    19
    100%
    36
    100%

    Outcome Measures

    1. Primary Outcome
    Title Number of Participants Who Experience Airway Maneuvers
    Description In high risk patients (meeting at least of 1 of 3 criteria: ASA ≥ 3, BMI ≥ 30, those at risk for OSA) undergoing advanced endoscopy procedures, compare the number of participants who experience airway maneuvers (AMs) when sedated with propofol alone versus propofol in combination with benzodiazepines and opioids.
    Time Frame One day (during procedure)

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Propofol+Benzo/Opioids Propofol Alone
    Arm/Group Description If the patient is randomized into this arm the recommended Versed and Fentanyl doses are standardized: Recommended Versed: a. Prior to intubation patient is < 50 kg = 1 mg Versed patient is 50-75 kg = 1.5 mg Versed patient is > 75 kg = 2 mg Versed Recommended Fentanyl Prior to intubation = 0.5 ug/kg Total procedural dose = 1 ug/kg Propofol+Benzo/Opioids: 1. Recommended Versed: a. Prior to intubation patient is < 50 kg = 1 mg Versed patient is 50-75 kg = 1.5 mg Versed patient is > 75 kg = 2 mg Versed 2. Recommended Fentanyl a. Prior to intubation = 0.5 ug/kg b. Total procedural dose = 1 ug/kg The patients randomized into the sedation with propofol alone are able to cross over if they are unable to be successfully sedated under propofol alone. The the recommended doses before considering crossover are standardized: Induction Dose: 2-2.5 mg/kg Maintenance Dose: 0.1-0.2 mg/kg/min Propofol Alone: Recommended Propofol doses before considering crossover: Induction: 2-2.5 mg/kg Maintenance: 0.1-0.2 mg/kg/min
    Measure Participants 17 19
    Number [participants]
    4
    23.5%
    4
    21.1%
    2. Secondary Outcome
    Title Number of Participants Who Experience Other Sedation Related Complications
    Description Compare the number of participants who experience other sedation related complications such as hypotension, hypoxemia and need for termination of the procedure between the two groups
    Time Frame One day (during procedure)

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Propofol+Benzo/Opioids Propofol Alone
    Arm/Group Description If the patient is randomized into this arm the recommended Versed and Fentanyl doses are standardized: Recommended Versed: a. Prior to intubation patient is < 50 kg = 1 mg Versed patient is 50-75 kg = 1.5 mg Versed patient is > 75 kg = 2 mg Versed Recommended Fentanyl Prior to intubation = 0.5 ug/kg Total procedural dose = 1 ug/kg Propofol+Benzo/Opioids: 1. Recommended Versed: a. Prior to intubation patient is < 50 kg = 1 mg Versed patient is 50-75 kg = 1.5 mg Versed patient is > 75 kg = 2 mg Versed 2. Recommended Fentanyl a. Prior to intubation = 0.5 ug/kg b. Total procedural dose = 1 ug/kg The patients randomized into the sedation with propofol alone are able to cross over if they are unable to be successfully sedated under propofol alone. The the recommended doses before considering crossover are standardized: Induction Dose: 2-2.5 mg/kg Maintenance Dose: 0.1-0.2 mg/kg/min Propofol Alone: Recommended Propofol doses before considering crossover: Induction: 2-2.5 mg/kg Maintenance: 0.1-0.2 mg/kg/min
    Measure Participants 17 19
    Number [participants]
    0
    0%
    0
    0%
    3. Secondary Outcome
    Title Compare Propofol Doses Between the Two Groups
    Description The dose of propofol used between the two groups will be compared
    Time Frame One day (during procedure)

    Outcome Measure Data

    Analysis Population Description
    The data for this outcome measure was not collected and was not analyzed due to not having the necessary support to continue the study.
    Arm/Group Title Propofol+Benzo/Opioids Propofol Alone
    Arm/Group Description If the patient is randomized into this arm the recommended Versed and Fentanyl doses are standardized: Recommended Versed: a. Prior to intubation patient is < 50 kg = 1 mg Versed patient is 50-75 kg = 1.5 mg Versed patient is > 75 kg = 2 mg Versed Recommended Fentanyl Prior to intubation = 0.5 ug/kg Total procedural dose = 1 ug/kg Propofol+Benzo/Opioids: 1. Recommended Versed: a. Prior to intubation patient is < 50 kg = 1 mg Versed patient is 50-75 kg = 1.5 mg Versed patient is > 75 kg = 2 mg Versed 2. Recommended Fentanyl a. Prior to intubation = 0.5 ug/kg b. Total procedural dose = 1 ug/kg The patients randomized into the sedation with propofol alone are able to cross over if they are unable to be successfully sedated under propofol alone. The the recommended doses before considering crossover are standardized: Induction Dose: 2-2.5 mg/kg Maintenance Dose: 0.1-0.2 mg/kg/min Propofol Alone: Recommended Propofol doses before considering crossover: Induction: 2-2.5 mg/kg Maintenance: 0.1-0.2 mg/kg/min
    Measure Participants 0 0
    4. Secondary Outcome
    Title Predictors of Sedation Related Complications as Measured by the Number of Participants Who Experience Hypoxemia (Defined as a Pulse Oximetry <90% for Any Duration)
    Description
    Time Frame One year

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Propofol+Benzo/Opioids Propofol Alone
    Arm/Group Description If the patient is randomized into this arm the recommended Versed and Fentanyl doses are standardized: Recommended Versed: a. Prior to intubation patient is < 50 kg = 1 mg Versed patient is 50-75 kg = 1.5 mg Versed patient is > 75 kg = 2 mg Versed Recommended Fentanyl Prior to intubation = 0.5 ug/kg Total procedural dose = 1 ug/kg Propofol+Benzo/Opioids: 1. Recommended Versed: a. Prior to intubation patient is < 50 kg = 1 mg Versed patient is 50-75 kg = 1.5 mg Versed patient is > 75 kg = 2 mg Versed 2. Recommended Fentanyl a. Prior to intubation = 0.5 ug/kg b. Total procedural dose = 1 ug/kg The patients randomized into the sedation with propofol alone are able to cross over if they are unable to be successfully sedated under propofol alone. The the recommended doses before considering crossover are standardized: Induction Dose: 2-2.5 mg/kg Maintenance Dose: 0.1-0.2 mg/kg/min Propofol Alone: Recommended Propofol doses before considering crossover: Induction: 2-2.5 mg/kg Maintenance: 0.1-0.2 mg/kg/min
    Measure Participants 17 19
    Number [participants]
    0
    0%
    0
    0%
    5. Secondary Outcome
    Title Predictors of Sedation Related Complications as Measured by Hypopnea/Apnea (Defined as Fewer Than 6 Breaths/Minute Based on Capnography)
    Description
    Time Frame One year

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Propofol+Benzo/Opioids Propofol Alone
    Arm/Group Description If the patient is randomized into this arm the recommended Versed and Fentanyl doses are standardized: Recommended Versed: a. Prior to intubation patient is < 50 kg = 1 mg Versed patient is 50-75 kg = 1.5 mg Versed patient is > 75 kg = 2 mg Versed Recommended Fentanyl Prior to intubation = 0.5 ug/kg Total procedural dose = 1 ug/kg Propofol+Benzo/Opioids: 1. Recommended Versed: a. Prior to intubation patient is < 50 kg = 1 mg Versed patient is 50-75 kg = 1.5 mg Versed patient is > 75 kg = 2 mg Versed 2. Recommended Fentanyl a. Prior to intubation = 0.5 ug/kg b. Total procedural dose = 1 ug/kg The patients randomized into the sedation with propofol alone are able to cross over if they are unable to be successfully sedated under propofol alone. The the recommended doses before considering crossover are standardized: Induction Dose: 2-2.5 mg/kg Maintenance Dose: 0.1-0.2 mg/kg/min Propofol Alone: Recommended Propofol doses before considering crossover: Induction: 2-2.5 mg/kg Maintenance: 0.1-0.2 mg/kg/min
    Measure Participants 17 19
    Number [incidences]
    0
    0
    6. Secondary Outcome
    Title Predictors of Sedation Related Complications as Measured by the Incidences of Hypotension (Defined as Systolic Blood Pressure of Less Than 90mmHg or a Decrease of More Than 25% From Baseline)
    Description
    Time Frame One year

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Propofol+Benzo/Opioids Propofol Alone
    Arm/Group Description If the patient is randomized into this arm the recommended Versed and Fentanyl doses are standardized: Recommended Versed: a. Prior to intubation patient is < 50 kg = 1 mg Versed patient is 50-75 kg = 1.5 mg Versed patient is > 75 kg = 2 mg Versed Recommended Fentanyl Prior to intubation = 0.5 ug/kg Total procedural dose = 1 ug/kg Propofol+Benzo/Opioids: 1. Recommended Versed: a. Prior to intubation patient is < 50 kg = 1 mg Versed patient is 50-75 kg = 1.5 mg Versed patient is > 75 kg = 2 mg Versed 2. Recommended Fentanyl a. Prior to intubation = 0.5 ug/kg b. Total procedural dose = 1 ug/kg The patients randomized into the sedation with propofol alone are able to cross over if they are unable to be successfully sedated under propofol alone. The the recommended doses before considering crossover are standardized: Induction Dose: 2-2.5 mg/kg Maintenance Dose: 0.1-0.2 mg/kg/min Propofol Alone: Recommended Propofol doses before considering crossover: Induction: 2-2.5 mg/kg Maintenance: 0.1-0.2 mg/kg/min
    Measure Participants 17 19
    Number [incidences]
    0
    0
    7. Secondary Outcome
    Title Predictors of Sedation Related Complications as Measured by Early Procedure Termination for an Alternative Sedation Related Complication
    Description
    Time Frame One year

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Propofol+Benzo/Opioids Propofol Alone
    Arm/Group Description If the patient is randomized into this arm the recommended Versed and Fentanyl doses are standardized: Recommended Versed: a. Prior to intubation patient is < 50 kg = 1 mg Versed patient is 50-75 kg = 1.5 mg Versed patient is > 75 kg = 2 mg Versed Recommended Fentanyl Prior to intubation = 0.5 ug/kg Total procedural dose = 1 ug/kg Propofol+Benzo/Opioids: 1. Recommended Versed: a. Prior to intubation patient is < 50 kg = 1 mg Versed patient is 50-75 kg = 1.5 mg Versed patient is > 75 kg = 2 mg Versed 2. Recommended Fentanyl a. Prior to intubation = 0.5 ug/kg b. Total procedural dose = 1 ug/kg The patients randomized into the sedation with propofol alone are able to cross over if they are unable to be successfully sedated under propofol alone. The the recommended doses before considering crossover are standardized: Induction Dose: 2-2.5 mg/kg Maintenance Dose: 0.1-0.2 mg/kg/min Propofol Alone: Recommended Propofol doses before considering crossover: Induction: 2-2.5 mg/kg Maintenance: 0.1-0.2 mg/kg/min
    Measure Participants 17 19
    Number [incidences]
    0
    0
    8. Secondary Outcome
    Title Patient Tolerance as Assessed by Endoscopists
    Description The frequency of symptoms of nausea and vomiting in the two groups of patients will be recorded. Patient tolerance of the procedure will be assessed independently by the endoscopist using a 100-mm visual analog scale (VAS, 0=unmanageable, 100=excellent). The patient will also score the level of tolerance using the same VAS at a routine follow-up phone call made 24-48 hours after the procedure.
    Time Frame 24-48 hours

    Outcome Measure Data

    Analysis Population Description
    The data for this outcome measure was not collected and was not analyzed due to not having the necessary support to continue the study.
    Arm/Group Title Propofol+Benzo/Opioids Propofol Alone
    Arm/Group Description If the patient is randomized into this arm the recommended Versed and Fentanyl doses are standardized: Recommended Versed: a. Prior to intubation patient is < 50 kg = 1 mg Versed patient is 50-75 kg = 1.5 mg Versed patient is > 75 kg = 2 mg Versed Recommended Fentanyl Prior to intubation = 0.5 ug/kg Total procedural dose = 1 ug/kg Propofol+Benzo/Opioids: 1. Recommended Versed: a. Prior to intubation patient is < 50 kg = 1 mg Versed patient is 50-75 kg = 1.5 mg Versed patient is > 75 kg = 2 mg Versed 2. Recommended Fentanyl a. Prior to intubation = 0.5 ug/kg b. Total procedural dose = 1 ug/kg The patients randomized into the sedation with propofol alone are able to cross over if they are unable to be successfully sedated under propofol alone. The the recommended doses before considering crossover are standardized: Induction Dose: 2-2.5 mg/kg Maintenance Dose: 0.1-0.2 mg/kg/min Propofol Alone: Recommended Propofol doses before considering crossover: Induction: 2-2.5 mg/kg Maintenance: 0.1-0.2 mg/kg/min
    Measure Participants 0 0
    9. Secondary Outcome
    Title Number of Participants Who Experience Symptoms of Nausea and Vomiting Will be Compared Between the Two Groups
    Description The number of participants who experience symptoms of nausea and vomiting in the two groups of patients will be recorded. This will be recorded during the follow-up phone call made 24-48 hours after the procedure.
    Time Frame 24-48 hours

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Propofol+Benzo/Opioids Propofol Alone
    Arm/Group Description If the patient is randomized into this arm the recommended Versed and Fentanyl doses are standardized: Recommended Versed: a. Prior to intubation patient is < 50 kg = 1 mg Versed patient is 50-75 kg = 1.5 mg Versed patient is > 75 kg = 2 mg Versed Recommended Fentanyl Prior to intubation = 0.5 ug/kg Total procedural dose = 1 ug/kg Propofol+Benzo/Opioids: 1. Recommended Versed: a. Prior to intubation patient is < 50 kg = 1 mg Versed patient is 50-75 kg = 1.5 mg Versed patient is > 75 kg = 2 mg Versed 2. Recommended Fentanyl a. Prior to intubation = 0.5 ug/kg b. Total procedural dose = 1 ug/kg The patients randomized into the sedation with propofol alone are able to cross over if they are unable to be successfully sedated under propofol alone. The the recommended doses before considering crossover are standardized: Induction Dose: 2-2.5 mg/kg Maintenance Dose: 0.1-0.2 mg/kg/min Propofol Alone: Recommended Propofol doses before considering crossover: Induction: 2-2.5 mg/kg Maintenance: 0.1-0.2 mg/kg/min
    Measure Participants 17 19
    Number [participants]
    2
    11.8%
    1
    5.3%

    Adverse Events

    Time Frame
    Adverse Event Reporting Description
    Arm/Group Title Propofol+Benzo/Opioids Propofol Alone
    Arm/Group Description If the patient is randomized into this arm the recommended Versed and Fentanyl doses are standardized: Recommended Versed: a. Prior to intubation patient is < 50 kg = 1 mg Versed patient is 50-75 kg = 1.5 mg Versed patient is > 75 kg = 2 mg Versed Recommended Fentanyl Prior to intubation = 0.5 ug/kg Total procedural dose = 1 ug/kg Propofol+Benzo/Opioids: 1. Recommended Versed: a. Prior to intubation patient is < 50 kg = 1 mg Versed patient is 50-75 kg = 1.5 mg Versed patient is > 75 kg = 2 mg Versed 2. Recommended Fentanyl a. Prior to intubation = 0.5 ug/kg b. Total procedural dose = 1 ug/kg The patients randomized into the sedation with propofol alone are able to cross over if they are unable to be successfully sedated under propofol alone. The the recommended doses before considering crossover are standardized: Induction Dose: 2-2.5 mg/kg Maintenance Dose: 0.1-0.2 mg/kg/min Propofol Alone: Recommended Propofol doses before considering crossover: Induction: 2-2.5 mg/kg Maintenance: 0.1-0.2 mg/kg/min
    All Cause Mortality
    Propofol+Benzo/Opioids Propofol Alone
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN)
    Serious Adverse Events
    Propofol+Benzo/Opioids Propofol Alone
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/17 (0%) 0/19 (0%)
    Other (Not Including Serious) Adverse Events
    Propofol+Benzo/Opioids Propofol Alone
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/17 (0%) 0/19 (0%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    All Principal Investigators ARE employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title Faris Murad, M.D.
    Organization Washington University School of Medicine
    Phone
    Email fmurad@northshore.org
    Responsible Party:
    Washington University School of Medicine
    ClinicalTrials.gov Identifier:
    NCT01315158
    Other Study ID Numbers:
    • 10-1133
    First Posted:
    Mar 15, 2011
    Last Update Posted:
    Oct 28, 2016
    Last Verified:
    Sep 1, 2016