Ketamine and Propofol Combination Versus Propofol for Upper Gastrointestinal Endoscopy

Obesity Clinical Trial

Official title:

Ketamine and Propofol Combination Versus Propofol for Upper Gastrointestinal Endoscopy

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02643979
• Other study ID #: GCO 15-2139
• Status: Terminated
• Phase: Phase 4
• Start date: January 1, 2016
• Est. completion date: January 5, 2019

Study information

• Verified date: January 2020
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 22
• Est. completion date: January 5, 2019
• Est. primary completion date: January 5, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bariatrics
• Endoscopy
• Gastric Bypass
• Obesity
• Sleep Apnea Syndromes

Intervention

Drug:
• Ketofol
50mg of Ketamine mixed with 100mg of Propofol
• Propofol
100mg of Propofol
• Saline
1mL of saline

Locations

Country	Name	City	State
United States	Icahn School of Medicine at Mount Sinai	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai

Country where clinical trial is conducted

United States, 

References & Publications (6)

Dal T, Sazak H, Tunç M, Sahin S, Yilmaz 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Gagging Reaction	Number of participants with gagging or "vomit-like" reaction on endoscopic insertion	Day 1
Secondary	Number of Participants With Any Type of Airway Obstruction	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
Secondary	Total Dose of Propofol Used During the Procedure	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
Secondary	Total Sedation Required to Allow Initiation of Procedure	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
Secondary	Number of Participants With Post-operative Nausea and/or Vomiting		up to 6 months
Secondary	Number of Participants With Emergence Delirium	Number of participants with emergence delirium measured from the procedure end until time of discharge.	Day 1
Secondary	Time to Recovery	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