Ketamine and Propofol Combination Versus Propofol for Upper Gastrointestinal Endoscopy

• Sponsor: Icahn School of Medicine at Mount Sinai (Other)
• Overall Status: Terminated
• CT.gov ID: NCT02643979
• Collaborator: (none)
• Enrollment: 22
• Location: 1
• Arms: 2
• Actual Duration (Months): 36.1
• Patients Per Site Per Month: 0.6

Study Details

Study Description

Brief Summary

Propofol is one of the most popular anesthetic drugs used for sedation during upper gastrointestinal endoscopies due to its quick onset and quick resolution of symptoms allowing patients to leave the hospital sooner. However, when administered it can also slow the breathing of patients and cause others to have upper airway obstruction (such as snoring) which can impede proper spontaneous breathing. Ketamine is an agent that is capable of providing both pain control and sedation while having either minimal effect on breathing or promoting spontaneous breathing. Combining Ketamine with Propofol has the potential to reduce the total amount of Propofol used resulting in a procedure being performed under the same level of sedation but without the downside of reduced spontaneous breathing. Patients who are obese (defined as body mass index greater than 35) tend to be even more susceptible to this effect of Propofol. The researchers are investigating whether the addition of Ketamine will indeed allow for this continued comfortable level of sedation while promoting continued spontaneous breathing in obese patients undergoing upper gastrointestinal endoscopies.

Condition or Disease	Intervention/Treatment	Phase
Obesity; Bariatrics; Sleep Apnea Syndromes; Gastric Bypass; Endoscopy	Drug: Ketofol; Drug: Propofol; Drug: Saline	Phase 4

Detailed Description

Upon patient arrival to endoscopy suite heart rate (HR), pre-procedure baseline blood pressure (BP), and pre-procedure oxygen saturation (SPO2) via pulse oximeter are recorded in endoscopy holding area, patient alertness and orientation assessed (respond to name, know the state, know the hospital, know the year, know the season).

Once the subject enters the endoscopy suite monitors are placed to record starting BP, HR, SPO2 recorded, nasal cannula with end tidal carbon dioxide (CO2) monitor attached, and 5-lead ECG.

Following time out patient given 100mg Lidocaine IV bolus, 1-minute delay, then study-provided syringe administered. Once patient assessed to produce an RSS score >5 (Asleep with sluggish response to glabellar tap or NO response) endoscopy proceeds.

Recorder (blinded) notes if initially provided syringe alone was enough to produce an RSS >5, notes subject's response to endoscopy insertion (presence or absence of gagging), notes amount of additional propofol required to maintain adequate conditions to continue endoscopy, records non-invasive blood pressure (NIBP) at 3-minute intervals, notes for level of airway obstruction (obstruction with continued air movement, obstruction requiring chin lift or jaw thrust for relief, obstruction requiring progression to assisted ventilation or intubation), notes for desaturation events (SPO2 <90% with a coherent waveform).

At the end of the procedure the total anesthesia time is recorded, total procedure start-to-finish time recorded, total dose of propofol recorded, and any incidence of patient agitation noted.

Once in recovery the recovery room admission HR, SPO2, NIBP recorded followed by admission +15 minutes HR, SPO2, and NIBP, any incidence of desaturation (<90% SPO2 with waveform) recorded, incidence of airway obstruction (with air movement, requiring airway maneuver, requiring intervention) recorded, time until patient is alert and oriented recorded (response to name, able to state what state they are in, able to state what hospital they are in, able to state the year, able to state the season), time-until-recovered recorded (Modified Aldrete Score > 9), incidence of nausea prior to recovery recorded, incidence of vomiting prior to recovery recorded, incidence of agitation or delirium prior to recovery recorded.

Study Design

• Study Type: Interventional
• Actual Enrollment: 22 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Care Provider)
• Primary Purpose: Supportive Care
• Official Title: Ketamine and Propofol Combination Versus Propofol for Upper Gastrointestinal Endoscopy
• Actual Study Start Date: Jan 1, 2016
• Actual Primary Completion Date: Jan 5, 2019
• Actual Study Completion Date: Jan 5, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Ketofol and Propofol This arm receives a 50mg dose of Ketamine mixed with 100mg of Propofol at the start of their upper endoscopy.	Drug: Ketofol; 50mg of Ketamine mixed with 100mg of Propofol; Other Names: Ketamine and Propofol Ketalar Diprivan ; Drug: Propofol; 100mg of Propofol; Other Names: Diprivan
Active Comparator: Propofol only This arm receives 100mg of Propofol mixed with 1mL of saline at the start of the upper gastrointestinal endoscopy.	Drug: Propofol; 100mg of Propofol; Other Names: Diprivan ; Drug: Saline; 1mL of saline

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Gagging Reaction [Day 1]

   Number of participants with gagging or "vomit-like" reaction on endoscopic insertion

Secondary Outcome Measures

1. Number of Participants With Any Type of Airway Obstruction [Day 1]

   The Anesthesiologist caring for the patient during the upper endoscopy made note of any obstructive events defined on a scale ranging from the patient audibly snoring (obstructing) to the patient obstructing and requiring assistance such as a chin lift or jaw thrust to relieve the obstruction and continue to move air adequately.

2. Total Dose of Propofol Used During the Procedure [Day 1]

   Propofol doses are logged in the computerized Compurecord system used in the operating room. Patients involved in the study had their total Propofol dose required quantified and compared between groups who received Ketamine and groups who did not.

3. Total Sedation Required to Allow Initiation of Procedure [Day 1]

   Using the computerized record system, the amount of Propofol a patient required to allow for the procedure to start quantified and compared between groups.

4. Number of Participants With Post-operative Nausea and/or Vomiting [up to 6 months]

5. Number of Participants With Emergence Delirium [Day 1]

   Number of participants with emergence delirium measured from the procedure end until time of discharge.

6. Time to Recovery [Day 1]

   Monitored via the electronic medical record system as the time between the anesthesia end time and when the patient was safe for discharge from the hospital.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• BMI > 30

• Undergoing an upper gastrointestinal endoscopy

Exclusion Criteria:

• History of schizophrenia/schizoaffective disorder

• History of bipolar disorder

• History of dementia

• Non-English Speaking

• History of Glaucoma

• Craniofacial Abnormalities

• Epilepsy

• Allergy to Propofol

• Allergy to Ketamine

• Current known intracranial mass/lesion

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Icahn School of Medicine at Mount Sinai	New York	New York	United States	10029

Sponsors and Collaborators

• Icahn School of Medicine at Mount Sinai

Investigators

• Principal Investigator: Daniel J Katz, MD, Icahn School of Medicine at Mount Sinai
• Study Director: David A Maerz, MD, Icahn School of Medicine at Mount Sinai

Study Documents (Full-Text)

• Study Protocol - Aug 28, 2015
• Statistical Analysis Plan - Dec 20, 2015

More Information

Publications

• Dal T, Sazak H, Tunç M, Sahin S, Yılmaz A. A comparison of ketamine-midazolam and ketamine-propofol combinations used for sedation in the endobronchial ultrasound-guided transbronchial needle aspiration: a prospective, single-blind, randomized study. J Thorac Dis. 2014 Jun;6(6):742-51. doi: 10.3978/j.issn.2072-1439.2014.04.10.
• Newton A, Fitton L. Intravenous ketamine for adult procedural sedation in the emergency department: a prospective cohort study. Emerg Med J. 2008 Aug;25(8):498-501. doi: 10.1136/emj.2007.053421.
• Pambianco DJ. Future directions in endoscopic sedation. Gastrointest Endosc Clin N Am. 2008 Oct;18(4):789-99, x. doi: 10.1016/j.giec.2008.06.004. Review.
• Sih K, Campbell SG, Tallon JM, Magee K, Zed PJ. Ketamine in adult emergency medicine: controversies and recent advances. Ann Pharmacother. 2011 Dec;45(12):1525-34. doi: 10.1345/aph.1Q370. Epub 2011 Dec 6. Review.
• Street MH, Gerard JM. A fixed-dose ketamine protocol for adolescent sedations in a pediatric emergency department. J Pediatr. 2014 Sep;165(3):453-8. doi: 10.1016/j.jpeds.2014.03.021. Epub 2014 Apr 20.
• Tandon M, Pandey VK, Dubey GK, Pandey CK, Wadhwa N. Addition of sub-anaesthetic dose of ketamine reduces gag reflex during propofol based sedation for upper gastrointestinal endoscopy: A prospective randomised double-blind study. Indian J Anaesth. 2014 Jul;58(4):436-41. doi: 10.4103/0019-5049.138981.

• Responsible Party: Daniel Katz, Assistant Professor, Icahn School of Medicine at Mount Sinai
• ClinicalTrials.gov Identifier: NCT02643979
• Other Study ID Numbers: GCO 15-2139
• First Posted: Dec 31, 2015
• Last Update Posted: Feb 11, 2020
• Last Verified: Jan 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Keywords provided by Daniel Katz, Assistant Professor, Icahn School of Medicine at Mount Sinai: Ketamine; Propofol; Ketofol; Obese; Upper gastrointestinal endoscopy; Sedation; Bariatric
• Additional relevant MeSH terms: Sleep Apnea Syndromes; Ketamine; Propofol

Study Results

Participant Flow

Arm/Group Title	Ketofol: Ketamine and Propofol	Propofol Only
Arm/Group Description	This arm received a 50mg dose of Ketamine mixed with 100mg of Propofol at the start of their upper endoscopy.	This arm received 100mg of Propofol mixed with 1mL of saline at the start of the upper gastrointestinal endoscopy.
Period Title: Overall Study
STARTED	11	11
COMPLETED	11	11
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Ketofol: Ketamine and Propofol	Propofol Only	Total
Arm/Group Description	This arm received a 50mg dose of Ketamine mixed with 100mg of Propofol at the start of their upper endoscopy.	This arm received 100mg of Propofol mixed with 1mL of saline at the start of the upper gastrointestinal endoscopy.	Total of all reporting groups
Overall Participants	11	11	22
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	53.09 (16.0)	44.63 (9.39)	48.86 (13.7)
Sex: Female, Male (Count of Participants)
Female	8 72.7%	7 63.6%	15 68.2%
Male	3 27.3%	4 36.4%	7 31.8%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	3 27.3%	2 18.2%	5 22.7%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	2 18.2%	2 18.2%	4 18.2%
White	5 45.5%	7 63.6%	12 54.5%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	1 9.1%	0 0%	1 4.5%
Body Mass Index (BMI) (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]	41 (5.4)	44 (8.3)	42.5 (7.2)
ASA Class (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	2.9 (0.2)	3 (0)	2.9 (0.2)

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Gagging Reaction
Description	Number of participants with gagging or "vomit-like" reaction on endoscopic insertion
Time Frame	Day 1

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Ketofol: Ketamine and Propofol	Propofol Only
Arm/Group Description	This arm received a 50mg dose of Ketamine mixed with 100mg of Propofol at the start of their upper endoscopy.	This arm received 100mg of Propofol mixed with 1mL of saline at the start of the upper gastrointestinal endoscopy.
Measure Participants	11	11
Count of Participants [Participants]	2 18.2%	1 9.1%

2. Secondary Outcome

Title	Number of Participants With Any Type of Airway Obstruction
Description	The Anesthesiologist caring for the patient during the upper endoscopy made note of any obstructive events defined on a scale ranging from the patient audibly snoring (obstructing) to the patient obstructing and requiring assistance such as a chin lift or jaw thrust to relieve the obstruction and continue to move air adequately.
Time Frame	Day 1

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Ketofol: Ketamine and Propofol	Propofol Only
Arm/Group Description	This arm received a 50mg dose of Ketamine mixed with 100mg of Propofol at the start of their upper endoscopy.	This arm received 100mg of Propofol mixed with 1mL of saline at the start of the upper gastrointestinal endoscopy.
Measure Participants	11	11
Count of Participants [Participants]	4 36.4%	3 27.3%

3. Secondary Outcome

Title	Total Dose of Propofol Used During the Procedure
Description	Propofol doses are logged in the computerized Compurecord system used in the operating room. Patients involved in the study had their total Propofol dose required quantified and compared between groups who received Ketamine and groups who did not.
Time Frame	Day 1

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Ketofol: Ketamine and Propofol	Propofol Only
Arm/Group Description	This arm received a 50mg dose of Ketamine mixed with 100mg of Propofol at the start of their upper endoscopy.	This arm received 100mg of Propofol mixed with 1mL of saline at the start of the upper gastrointestinal endoscopy.
Measure Participants	11	11
Mean (Standard Deviation) [mg/kg]	9.09 (19)	39 (57.3)

4. Secondary Outcome

Title	Total Sedation Required to Allow Initiation of Procedure
Description	Using the computerized record system, the amount of Propofol a patient required to allow for the procedure to start quantified and compared between groups.
Time Frame	Day 1

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Ketofol: Ketamine and Propofol	Propofol Only
Arm/Group Description	This arm received a 50mg dose of Ketamine mixed with 100mg of Propofol at the start of their upper endoscopy.	This arm received 100mg of Propofol mixed with 1mL of saline at the start of the upper gastrointestinal endoscopy.
Measure Participants	11	11
Mean (Standard Deviation) [mg/kg]	78 (50.6)	61 (57.2)

5. Secondary Outcome

Title	Number of Participants With Post-operative Nausea and/or Vomiting
Time Frame	up to 6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Ketofol: Ketamine and Propofol	Propofol Only
Arm/Group Description	This arm received a 50mg dose of Ketamine mixed with 100mg of Propofol at the start of their upper endoscopy.	This arm received 100mg of Propofol mixed with 1mL of saline at the start of the upper gastrointestinal endoscopy.
Measure Participants	11	11
Count of Participants [Participants]	0 0%	0 0%

6. Secondary Outcome

Title	Number of Participants With Emergence Delirium
Description	Number of participants with emergence delirium measured from the procedure end until time of discharge.
Time Frame	Day 1

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Ketofol: Ketamine and Propofol	Propofol Only
Arm/Group Description	This arm received a 50mg dose of Ketamine mixed with 100mg of Propofol at the start of their upper endoscopy.	This arm received 100mg of Propofol mixed with 1mL of saline at the start of the upper gastrointestinal endoscopy.
Measure Participants	11	11
Count of Participants [Participants]	0 0%	0 0%

7. Secondary Outcome

Title	Time to Recovery
Description	Monitored via the electronic medical record system as the time between the anesthesia end time and when the patient was safe for discharge from the hospital.
Time Frame	Day 1

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Ketofol: Ketamine and Propofol	Propofol Only
Arm/Group Description	This arm received a 50mg dose of Ketamine mixed with 100mg of Propofol at the start of their upper endoscopy.	This arm received 100mg of Propofol mixed with 1mL of saline at the start of the upper gastrointestinal endoscopy.
Measure Participants	11	11
Mean (Standard Deviation) [minutes]	21 (9)	25 (5)

Adverse Events

Time Frame	6 months
Arm/Group Title	Ketofol and Propofol		Propofol Only
Arm/Group Description	This arm received a 50mg dose of Ketamine mixed with 100mg of Propofol at the start of their upper endoscopy.		This arm received 100mg of Propofol mixed with 1mL of saline at the start of the upper gastrointestinal endoscopy.
All Cause Mortality
	Ketofol and Propofol		Propofol Only
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/11 (0%)		0/11 (0%)
Serious Adverse Events
	Ketofol and Propofol		Propofol Only
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/11 (0%)		0/11 (0%)
Other (Not Including Serious) Adverse Events
	Ketofol and Propofol		Propofol Only
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/11 (0%)		0/11 (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.