Ketamine and Propofol Combination Versus Propofol for Upper Gastrointestinal Endoscopy

January 28, 2020 updated by: Daniel Katz, Icahn School of Medicine at Mount Sinai
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

22

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10029
        • Icahn School of Medicine at Mount Sinai

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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:
  • Ketalar
  • Diprivan
  • Ketamine and Propofol
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Any Type of Airway Obstruction
Time Frame: 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.
Day 1
Total Dose of Propofol Used During the Procedure
Time Frame: 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.
Day 1
Total Sedation Required to Allow Initiation of Procedure
Time Frame: 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.
Day 1
Number of Participants With Post-operative Nausea and/or Vomiting
Time Frame: up to 6 months
up to 6 months
Number of Participants With Emergence Delirium
Time Frame: Day 1
Number of participants with emergence delirium measured from the procedure end until time of discharge.
Day 1
Time to Recovery
Time Frame: 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.
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2016

Primary Completion (Actual)

January 5, 2019

Study Completion (Actual)

January 5, 2019

Study Registration Dates

First Submitted

December 22, 2015

First Submitted That Met QC Criteria

December 29, 2015

First Posted (Estimate)

December 31, 2015

Study Record Updates

Last Update Posted (Actual)

February 11, 2020

Last Update Submitted That Met QC Criteria

January 28, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GCO 15-2139

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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