Number of participants with gagging or "vomit-like" reaction on endoscopic insertion
Ketamine and Propofol Combination Versus Propofol for Upper Gastrointestinal Endoscopy
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.
Intervention / Treatment
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Ketofol (DRUG)50mg of Ketamine mixed with 100mg of Propofol
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Propofol (DRUG)100mg of Propofol
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Saline (DRUG)1mL of saline
Condition or Disease
- Obesity
- Bariatrics
- Sleep Apnea Syndromes
- Gastric Bypass
- Endoscopy
Phase
Study Design
| Study type: | INTERVENTIONAL |
|---|---|
| Status: | Terminated |
| Study results: | No Results Available |
| Age: | 18 Years and older (Adult, Older Adult) |
| Enrollment: | 22 (ACTUAL) |
| Funded by: | Other |
| Allocation: | Randomized |
| Primary Purpose: | Supportive Care |
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Clinical Trial Dates
| Start date: | Jan 01, 2016 | ACTUAL |
|---|---|---|
| Primary Completion: | Jan 05, 2019 | ACTUAL |
| Completion Date: | Jan 05, 2019 | ACTUAL |
| Study First Posted: | Dec 31, 2015 | ESTIMATED |
| Results First Posted: | Jan 28, 2020 | ACTUAL |
| Last Updated: | Jan 28, 2020 |
Sponsors / Collaborators
Lead Sponsor:
Icahn School of Medicine at Mount Sinai
Responsible Party:
N/A
Location
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.
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.
Participant Groups
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This arm receives a 50mg dose of Ketamine mixed with 100mg of Propofol at the start of their upper endoscopy.
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This arm receives 100mg of Propofol mixed with 1mL of saline at the start of the upper gastrointestinal endoscopy.
Eligibility Criteria
| Sex: | All |
|---|---|
| Minimum Age: | 18 |
| Age Groups: | Adult / Older Adult |
| 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
* 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
Primary Outcomes
Secondary Outcomes
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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.
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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.
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Using the computerized record system, the amount of Propofol a patient required to allow for the procedure to start quantified and compared between groups.
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Number of Participants With Post-operative Nausea and/or Vomiting up to 6 months
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Number of participants with emergence delirium measured from the procedure end until time of discharge.
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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.
More Details
| NCT Number: | NCT02643979 |
|---|---|
| Other IDs: | GCO 15-2139 |
| Study URL: | https://clinicaltrials.gov/study/NCT02643979 |
Last updated: Sep 29, 2023