Clinical trial NCT03461718: Ketamine for Endoscopic Sedation in Outpatient Adult Endoscopy.
Official title: Ketamine as a Sedation Adjunct for Endoscopic Procedures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Administration and Dosage of Ketamine
Endoscopic Sedation
Lead sponsor: Brooke Army Medical Center
Sponsor class: FED
First posted: 2018-03-12
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: We will be investigating the use of ketamine in sedation for endoscopic procedures, specifically outpatient endoscopy including esophagoduodenoscopy (EGD) and colonoscopy. Participants will be randomized to one of two arms including conventional moderate sedation with midazolam and fentanyl or the ketamine arm. They will then undergo the planned procedure. Physicians preforming the procedure will be surveyed following the procedure and patients will be surveyed twice, once after meeting criteria for discharge on day of the procedure and a second time 48 hours following the procedure.

Detailed description: In this study, the investigators plan to conduct a single blinded randomized controlled trial in the Gastroenterology Service to demonstrate the efficacy of ketamine and its utility in moderate sedation. Patients presenting to the endoscopy lab for esophagogastroduodenoscopy (EGD) and/or colonoscopy who meet inclusion criteria will be approached, and if amenable, will be consented and enrolled. Patients will be randomized to receive either a ketamine loading dose and then subsequent doses IV ketamine and midazolam 1mg IV prior to administration of ketamine or standard fentanyl/midazolam moderate sedation during their procedure. Participants will then undergo the planned procedure. The primary outcome will be patient satisfaction, which will be measured using the validated "Patient Satisfaction with Sedation" instrument (PSSI). A number of secondary outcomes will include the following: (1) provider satisfaction (measured using and the "Clinician Satisfaction with Sedation" instrument (CSSI), (2) the time from sedation administration to procedure start (when the scope is inserted), (3) the time from sedation to recovery (defined as the time from the end of the procedure until the patient meets discharge criteria from the recovery area), (4) time to cecum (for colonoscopy) total doses of medications given (midazolam, fentanyl, and ketamine), (5) overall time of the procedure, (6) adverse events, (7) changes in vital signs, (8) and the need for additional medications, in particular reversal agents.

Eligibility criteria: Inclusion Criteria:

* Patients age 18 to 65 years who present to the GI clinic for an EGD or colonoscopy

Exclusion Criteria:

* Poor vital sign stability
* Hypoxia: O2 \< 92%,
* Hypotension, hypertension, heart rate and respiratory rates greater than 20% above or below normal as dictated by normal ranges in SAMMC protocol
* Any allergy to ketamine, fentanyl, or midazolam
* Patient is pregnant or refuses pregnancy test, in women of child-bearing potential.\*
* American Society of Anesthesiologists (ASA) score\>3
* Presence of a history of psychosis, hallucinations, and/or a psychotic disorder
* History of increased intracranial pressure/ hypertensive hydrocephalus within the last 3 months
* Active pulmonary infection or disease.
* History of airway instability, tracheal surgery, or tracheal stenosis.

  * \* Not applicable if patient is a female over 50 years old or has had a hysterectomy and/or oophorectomy

Primary outcomes:
measure: Provider satisfaction
timeFrame: Measured within 15 minutes post proceudre
Secondary outcomes:
measure: Sedation time
timeFrame: During the procedure
measure: Time to cecum (for colonoscopy)
timeFrame: During the procedure
measure: Total dose of medications given
timeFrame: During the procedure
measure: Overall procedure time
timeFrame: During the procedure
measure: Adverse events
timeFrame: During the procedure
measure: Changes in vital signs
timeFrame: During the procedure
measure: Need for additional medications, ie reversal agents
timeFrame: During the procedure
measure: Patient Satisfaction
timeFrame: After patient reaches criteria for discharge as listed above, a survey will be preformed. It will also be preformed 48 hours post procedure with the patients being called. Two surveys will end patient participation in the study.
Other outcomes:
Locations:
city: Fort Sam Houston
country: United States
facility: Brooke Army Medical Center
state: Texas
Study officials:
affiliation: BAMC
name: Jerome C Edelson, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: BAMC
name: John G Gancayco, MD
role: STUDY_CHAIR
affiliation: BAMC
name: Cyrus V Edelson, MD
role: STUDY_DIRECTOR
References:
citation: Edelson JC, Edelson CV, Rockey DC, Morales AL, Chung KK, Robles MJ, Marowske JH, Patel AA, Edelson SFD, Subramanian SR, Gancayco JG. Randomized Controlled Trial of Ketamine and Moderate Sedation for Outpatient Endoscopy in Adults. Mil Med. 2024 Jan 23;189(1-2):313-320. doi: 10.1093/milmed/usac183.