Moderate Versus Deep Procedural Sedation With Propofol in the Emergency Department

• Sponsor: Hennepin Healthcare Research Institute (Other)
• Overall Status: Completed
• CT.gov ID: NCT02404610
• Collaborator: (none)
• Enrollment: 107
• Location: 1
• Arms: 2
• Duration (Months): 53
• Patients Per Site Per Month: 2

Study Details

Study Description

Brief Summary

This study is a clinical trial of moderate sedation versus deep sedation with propofol for procedural sedation in the Emergency Department. The purpose of this study is to compare the rate of amnesia and respiratory depression rate in patients who receive moderate sedation to those that receive deep sedation.

Condition or Disease	Intervention/Treatment	Phase
Pain	Procedure: Moderate Procedural Sedation with a sedative medication.; Procedure: Deep Procedural Sedation with a sedative medication.; Drug: propofol	Phase 4

Detailed Description

Purpose: For the pilot phase, if the visual memory assessment test developed in this study can adequately assess periods of amnesia during the procedure, then it can be used for the phase of the study that randomizes patients to moderate or deep sedation. The purpose of the randomized phase is to compare the rate of amnesia and respiratory depression in patients who receive moderate sedation to those that received deep sedation. The goal is to determine whether moderate sedation could provide a safer sedation while still resulting in adequate amnesia of the procedure. Secondary goals would be to compare the duration of sedation, the success of the procedures for which the patient is sedated, procedural difficulty, the rate of hypotension and other adverse events, and the patient perception of the quality of the sedation (pain or recall of procedure).

Background: Adequate pain control and alleviation of anxiety improves quality of care and patient satisfaction. Numerous studies have found that procedural sedation (PS) in the ED is safe, and when properly administered, the incidence of reported complications, including clinically significant respiratory depression, is rare. Procedural sedation is used for procedures such as fracture reduction, dislocation reduction, cardioversion, incision and drainage, and chest tube placement. Propofol is an anesthetic agent frequently used for PS in the Emergency Department (ED) and produces sedation, hypnosis, and amnesia, but lacks analgesic properties. In studies conducted at Hennepin County Medical Center (HCMC), we have found that patients are unable to recall whether or not they experienced pain during the procedure when sedated with propofol. However, there is the possibility that certain parts of the procedure can be later recalled by the patient. If extensive parts of the procedure can be recalled, then this is not an effective sedation. Previous studies of memory during sedation at HCMC have used verbal prompts only, but research has shown that people can more readily remember images. Images may provide a more sensitive way to determine the degree of amnesia during sedation.

Study Design

• Study Type: Interventional
• Actual Enrollment: 107 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Moderate Versus Deep Procedural Sedation With Propofol in the Emergency Department
• Study Start Date: Jul 1, 2014
• Actual Primary Completion Date: Oct 1, 2018
• Actual Study Completion Date: Dec 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Moderate Procedural Sedation Subjects will undergo procedural sedation for an indicated urgent medical procedure with a target sedation level of moderate sedation. Moderate procedural sedation is a specific term referring to procedural sedation with a target depth of moderate.	Procedure: Moderate Procedural Sedation with a sedative medication.; procedural sedation with a target sedation depth of moderate. Moderate sedation is not a drug specific intervention, it is achieved with the use of a sedative or a combination of sedations and opioids.; Drug: propofol
Experimental: Deep Procedural Sedation Subjects will undergo procedural sedation for an indicated urgent medical procedure with a target sedation level of deep sedation. Deep procedural sedation is a specific term referring to procedural sedation with a target depth of deep.	Procedure: Deep Procedural Sedation with a sedative medication.; procedural sedation with a target sedation depth of deep. Deep sedation is not a drug specific intervention, it is achieved with the use of a sedative or a combination of sedations and opioids.; Drug: propofol

Outcome Measures

Primary Outcome Measures

1. Patients With Clinical Signs of Respiratory Depression or Sub Clinical Respiratory Depressions Measured by Capnography and Pulse Oximetry. [From start of procedure until the patient has returned to baseline mental status after the conclusion of the sedation procedure, an expected average time of 30 minutes]

   adverse respiratory events measured using capnography, pulse oximetry, and airway maneuvers performed during the sedation procedure

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Adults undergoing procedural sedation with propofol in the emergency department

Exclusion Criteria:

• < 18 years old

• Pregnant

• Previous allergic reaction to propofol

• Prisoner

• Unable to provide informed consent

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hennepin County Medical Center	Minneapolis	Minnesota	United States	55415

Sponsors and Collaborators

• Hennepin Healthcare Research Institute

Investigators

• Principal Investigator: Alexandra Schick, Hennepin Healthcare Research Institute

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Dec 30, 2014

More Information

Publications

• Miner JR, Biros M, Krieg S, Johnson C, Heegaard W, Plummer D. Randomized clinical trial of propofol versus methohexital for procedural sedation during fracture and dislocation reduction in the emergency department. Acad Emerg Med. 2003 Sep;10(9):931-7.
• Miner JR, Biros MH, Seigel T, Ross K. The utility of the bispectral index in procedural sedation with propofol in the emergency department. Acad Emerg Med. 2005 Mar;12(3):190-6.
• Miner JR, Danahy M, Moch A, Biros M. Randomized clinical trial of etomidate versus propofol for procedural sedation in the emergency department. Ann Emerg Med. 2007 Jan;49(1):15-22. Epub 2006 Sep 25.

• Responsible Party: Hennepin Healthcare Research Institute
• ClinicalTrials.gov Identifier: NCT02404610
• Other Study ID Numbers: HSR 13-3746
• First Posted: Mar 31, 2015
• Last Update Posted: Nov 30, 2021
• Last Verified: Nov 1, 2021

• Keywords provided by Hennepin Healthcare Research Institute: propofol; moderate procedural sedation; deep procedural sedation; memory; emergency department
• Additional relevant MeSH terms: Emergencies; Propofol; Hypnotics and Sedatives

Study Results

Participant Flow

Arm/Group Title	Moderate Procedural Sedation	Deep Procedural Sedation
Arm/Group Description	Subjects will undergo procedural sedation for an indicated urgent medical procedure with a target sedation level of moderate sedation. Moderate procedural sedation is a specific term referring to procedural sedation with a target depth of moderate. Moderate Procedural Sedation with a sedative medication.: procedural sedation with a target sedation depth of moderate. Moderate sedation is not a drug specific intervention, it is achieved with the use of a sedative or a combination of sedations and opioids. propofol	Subjects will undergo procedural sedation for an indicated urgent medical procedure with a target sedation level of deep sedation. Deep procedural sedation is a specific term referring to procedural sedation with a target depth of deep. Deep Procedural Sedation with a sedative medication.: procedural sedation with a target sedation depth of deep. Deep sedation is not a drug specific intervention, it is achieved with the use of a sedative or a combination of sedations and opioids. propofol
Period Title: Overall Study
STARTED	54	53
COMPLETED	54	53
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Moderate Procedural Sedation	Deep Procedural Sedation	Total
Arm/Group Description	Subjects will undergo procedural sedation for an indicated urgent medical procedure with a target sedation level of moderate sedation. Moderate procedural sedation is a specific term referring to procedural sedation with a target depth of moderate. Moderate Procedural Sedation with a sedative medication.: procedural sedation with a target sedation depth of moderate. Moderate sedation is not a drug specific intervention, it is achieved with the use of a sedative or a combination of sedations and opioids. propofol	Subjects will undergo procedural sedation for an indicated urgent medical procedure with a target sedation level of deep sedation. Deep procedural sedation is a specific term referring to procedural sedation with a target depth of deep. Deep Procedural Sedation with a sedative medication.: procedural sedation with a target sedation depth of deep. Deep sedation is not a drug specific intervention, it is achieved with the use of a sedative or a combination of sedations and opioids. propofol	Total of all reporting groups
Overall Participants	54	53	107
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	51 94.4%	49 92.5%	100 93.5%
>=65 years	3 5.6%	4 7.5%	7 6.5%
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	41.5	39	40
Sex: Female, Male (Count of Participants)
Female	30 55.6%	25 47.2%	55 51.4%
Male	24 44.4%	28 52.8%	52 48.6%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (participants) [Number]
United States	54 100%	53 100%	107 100%

Outcome Measures

1. Primary Outcome

Title	Patients With Clinical Signs of Respiratory Depression or Sub Clinical Respiratory Depressions Measured by Capnography and Pulse Oximetry.
Description	adverse respiratory events measured using capnography, pulse oximetry, and airway maneuvers performed during the sedation procedure
Time Frame	From start of procedure until the patient has returned to baseline mental status after the conclusion of the sedation procedure, an expected average time of 30 minutes

Outcome Measure Data

Analysis Population Description

patients undergoing procedural sedation in the ED

Arm/Group Title	Moderate Procedural Sedation	Deep Procedural Sedation
Arm/Group Description	Subjects will undergo procedural sedation for an indicated urgent medical procedure with a target sedation level of moderate sedation. Moderate procedural sedation is a specific term referring to procedural sedation with a target depth of moderate. Moderate Procedural Sedation with a sedative medication.: procedural sedation with a target sedation depth of moderate. Moderate sedation is not a drug specific intervention, it is achieved with the use of a sedative or a combination of sedations and opioids. propofol	Subjects will undergo procedural sedation for an indicated urgent medical procedure with a target sedation level of deep sedation. Deep procedural sedation is a specific term referring to procedural sedation with a target depth of deep. Deep Procedural Sedation with a sedative medication.: procedural sedation with a target sedation depth of deep. Deep sedation is not a drug specific intervention, it is achieved with the use of a sedative or a combination of sedations and opioids. propofol
Measure Participants	54	53
Count of Participants [Participants]	22 40.7%	21 39.6%

Adverse Events

Time Frame	From 3 minutes prior to the start of the sedation encounter up until the time the patient regained their baseline mental status up to 24 hours.
Adverse Event Reporting Description	adverse respiratory events were defined as the occurrence of one or more clinical features of respiratory depression, including an oxygen saturation <91%, a change in baseline ETCO2 of >10 mm HG, or a loss of ETCO2 waveform, associated with the occurrence of any supportive airway maneuvers, including the use of a bag-valve mask apparatus, airway repositioning, the use of an oral or nasal airway to improve ventilation, or any stimulation to induce respirations.
Arm/Group Title	Moderate Procedural Sedation		Deep Procedural Sedation
Arm/Group Description	Subjects will undergo procedural sedation for an indicated urgent medical procedure with a target sedation level of moderate sedation. Moderate procedural sedation is a specific term referring to procedural sedation with a target depth of moderate. Moderate Procedural Sedation with a sedative medication.: procedural sedation with a target sedation depth of moderate. Moderate sedation is not a drug specific intervention, it is achieved with the use of a sedative or a combination of sedations and opioids. propofol		Subjects will undergo procedural sedation for an indicated urgent medical procedure with a target sedation level of deep sedation. Deep procedural sedation is a specific term referring to procedural sedation with a target depth of deep. Deep Procedural Sedation with a sedative medication.: procedural sedation with a target sedation depth of deep. Deep sedation is not a drug specific intervention, it is achieved with the use of a sedative or a combination of sedations and opioids. propofol
All Cause Mortality
	Moderate Procedural Sedation		Deep Procedural Sedation
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/54 (0%)		0/53 (0%)
Serious Adverse Events
	Moderate Procedural Sedation		Deep Procedural Sedation
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/54 (0%)		0/53 (0%)
Other (Not Including Serious) Adverse Events
	Moderate Procedural Sedation		Deep Procedural Sedation
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	21/54 (38.9%)		24/53 (45.3%)
Respiratory, thoracic and mediastinal disorders
adverse respiratory event	21/54 (38.9%)	30	24/53 (45.3%)	40

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT 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.