Ketamine and Propofol Combination Versus Propofol for Upper Gastrointestinal Endoscopy
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02643979|
Recruitment Status : Recruiting
First Posted : December 31, 2015
Last Update Posted : September 27, 2018
|Condition or disease||Intervention/treatment||Phase|
|Obesity Bariatrics Sleep Apnea Syndromes Gastric Bypass Endoscopy||Drug: Ketofol Drug: Propofol Drug: Saline||Phase 4|
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 (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|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|
|Study Start Date :||December 2015|
|Estimated Primary Completion Date :||November 2019|
|Estimated Study Completion Date :||November 2019|
Experimental: Ketofol and Propofol
This arm receives a 50mg dose of Ketamine mixed with 100mg of Propofol at the start of their upper endoscopy.
50mg of Ketamine mixed with 100mg of Propofol
100mg of Propofol
Other Name: Diprivan
Active Comparator: Propofol only
This arm receives 100mg of Propofol mixed with 1mL of saline at the start of the upper gastrointestinal endoscopy.
100mg of Propofol
Other Name: Diprivan
1mL of saline
- Incidence of gagging reaction [ Time Frame: Day 1 ]Incidence of gagging or "vomit-like" reaction on endoscopic insertion
- Incidence of airway obstruction [ Time Frame: Day 1 ]The Anesthesiologist caring for the patient during the upper endoscopy will make 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.
- 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 will have their total Propofol dose required quantified and compared between groups who received Ketamine and groups who did not.
- Mean Arterial Pressure [ Time Frame: Day 1 ]
- Heart Rate [ Time Frame: 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 will be quantified and compared between groups.
- Incidence of Post-operative Nausea and/or Vomiting [ Time Frame: up to 6 months ]
- Incidence of Emergence Delirium [ Time Frame: up to 6 months ]This will be measured from the procedure end until time of discharge. Will monitor time it takes for patient to be alert and oriented to time, person, and their location.
- Time to Recovery [ Time Frame: up to 6 months ]This will be monitored via the electronic medical record system as the time between the anesthesia end time and when the patient is safe for discharge from the hospital.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02643979
|Contact: David A Maerz, MD||212-241-6500||David.Maerz@mountsinai.org|
|Contact: Daniel J Katz, MD||212-241-7473||Daniel.Katz@mountsinai.org|
|United States, New York|
|Icahn School of Medicine at Mount Sinai||Recruiting|
|New York, New York, United States, 10029|
|Principal Investigator: Daniel J Katz, MD|
|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|