Trial Outcomes & Findings for Ketamine and Propofol Combination Versus Propofol for Upper Gastrointestinal Endoscopy (NCT NCT02643979)

NCT ID: NCT02643979

Last Updated: 2020-02-11

Results Overview

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

• Recruitment status: TERMINATED
• Study phase: PHASE4
• Target enrollment: 22 participants
• Primary outcome timeframe: Day 1
• Results posted on: 2020-02-11

Participant Flow

Participant milestones

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

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Ketamine and Propofol Combination Versus Propofol for Upper Gastrointestinal Endoscopy

Baseline characteristics by cohort

Measure	Ketofol: Ketamine and Propofol n=11 Participants This arm received a 50mg dose of Ketamine mixed with 100mg of Propofol at the start of their upper endoscopy.	Propofol Only n=11 Participants This arm received 100mg of Propofol mixed with 1mL of saline at the start of the upper gastrointestinal endoscopy.	Total n=22 Participants Total of all reporting groups
Age, Continuous	53.09 years STANDARD_DEVIATION 16.0 • n=5 Participants	44.63 years STANDARD_DEVIATION 9.39 • n=7 Participants	48.86 years STANDARD_DEVIATION 13.7 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	7 Participants n=7 Participants	15 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants	7 Participants n=7 Participants	12 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Body Mass Index (BMI)	41 kg/m^2 STANDARD_DEVIATION 5.4 • n=5 Participants	44 kg/m^2 STANDARD_DEVIATION 8.3 • n=7 Participants	42.5 kg/m^2 STANDARD_DEVIATION 7.2 • n=5 Participants
ASA Class	2.9 units on a scale STANDARD_DEVIATION 0.2 • n=5 Participants	3 units on a scale STANDARD_DEVIATION 0 • n=7 Participants	2.9 units on a scale STANDARD_DEVIATION 0.2 • n=5 Participants

PRIMARY outcome

Timeframe: Day 1

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

Outcome measures

Measure	Ketofol: Ketamine and Propofol n=11 Participants This arm received a 50mg dose of Ketamine mixed with 100mg of Propofol at the start of their upper endoscopy.	Propofol Only n=11 Participants This arm received 100mg of Propofol mixed with 1mL of saline at the start of the upper gastrointestinal endoscopy.
Number of Participants With Gagging Reaction	2 Participants	1 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Ketofol: Ketamine and Propofol n=11 Participants This arm received a 50mg dose of Ketamine mixed with 100mg of Propofol at the start of their upper endoscopy.	Propofol Only n=11 Participants This arm received 100mg of Propofol mixed with 1mL of saline at the start of the upper gastrointestinal endoscopy.
Number of Participants With Any Type of Airway Obstruction	4 Participants	3 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Ketofol: Ketamine and Propofol n=11 Participants This arm received a 50mg dose of Ketamine mixed with 100mg of Propofol at the start of their upper endoscopy.	Propofol Only n=11 Participants This arm received 100mg of Propofol mixed with 1mL of saline at the start of the upper gastrointestinal endoscopy.
Total Dose of Propofol Used During the Procedure	9.09 mg/kg Standard Deviation 19	39 mg/kg Standard Deviation 57.3

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Ketofol: Ketamine and Propofol n=11 Participants This arm received a 50mg dose of Ketamine mixed with 100mg of Propofol at the start of their upper endoscopy.	Propofol Only n=11 Participants This arm received 100mg of Propofol mixed with 1mL of saline at the start of the upper gastrointestinal endoscopy.
Total Sedation Required to Allow Initiation of Procedure	78 mg/kg Standard Deviation 50.6	61 mg/kg Standard Deviation 57.2

SECONDARY outcome

Timeframe: up to 6 months

Outcome measures

Measure	Ketofol: Ketamine and Propofol n=11 Participants This arm received a 50mg dose of Ketamine mixed with 100mg of Propofol at the start of their upper endoscopy.	Propofol Only n=11 Participants This arm received 100mg of Propofol mixed with 1mL of saline at the start of the upper gastrointestinal endoscopy.
Number of Participants With Post-operative Nausea and/or Vomiting	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Day 1

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

Outcome measures

Measure	Ketofol: Ketamine and Propofol n=11 Participants This arm received a 50mg dose of Ketamine mixed with 100mg of Propofol at the start of their upper endoscopy.	Propofol Only n=11 Participants This arm received 100mg of Propofol mixed with 1mL of saline at the start of the upper gastrointestinal endoscopy.
Number of Participants With Emergence Delirium	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Ketofol: Ketamine and Propofol n=11 Participants This arm received a 50mg dose of Ketamine mixed with 100mg of Propofol at the start of their upper endoscopy.	Propofol Only n=11 Participants This arm received 100mg of Propofol mixed with 1mL of saline at the start of the upper gastrointestinal endoscopy.
Time to Recovery	21 minutes Standard Deviation 9	25 minutes Standard Deviation 5

Adverse Events

Ketofol and Propofol

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Propofol Only

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Daniel Katz

Icahn School of Medicine at Mount Sinai

Phone: 212-241-7475

Email: daniel.katz@mountsinai.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place