Ketamine for Endoscopic Sedation in Outpatient Adult Endoscopy.

Phase 2

Completed

• Conditions: Endoscopic Sedation; Administration and Dosage of Ketamine
• Interventions: Drug: Ketamine; Drug: Midazolam injection; Drug: Fentanyl

• Registration Number: NCT03461718
• Lead Sponsor: Brooke Army Medical Center

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.

Study Timeline

• Study First Submitted: 2018-02-23
• Study Start: 2018-03-05
• Study First Submitted QC: 2018-03-09
• Study First Posted: 2018-03-12
• Primary Completion: 2019-10-01
• Study Completion: 2019-10-01
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-07
• Last Update Posted: 2020-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ketamine	Midazolam injection	Group will receive ketamine 0.5-1mg/kg for a loading dose then subsequent IV pushes of 10-20mg for maintenance. 1mg IV of midazolam will be administered prior to ketamine for anxiolysis and to help minimize emergence reaction.
Control	Midazolam injection	This group will receive midazolam and fentanyl alternated as currently preformed for endoscopy.
Control	Fentanyl	This group will receive midazolam and fentanyl alternated as currently preformed for endoscopy.
Ketamine	Ketamine	Group will receive ketamine 0.5-1mg/kg for a loading dose then subsequent IV pushes of 10-20mg for maintenance. 1mg IV of midazolam will be administered prior to ketamine for anxiolysis and to help minimize emergence reaction.

Primary Outcome Measures

Name	Time	Method
Provider satisfaction	Measured within 15 minutes post proceudre	Measured with CSSI score. This consists of a questionnaire administered to the provider following the procedure with questions detailing different aspects of the procedure. Answers will be summed and the scores are normalized to a scale of 0-100 (high scores denote higher satisfaction).

Secondary Outcome Measures

Name	Time	Method
Sedation time	During the procedure	Time from sedation administration until procedure start, will be measured in minutes
Overall procedure time	During the procedure	The time from procedure start to procedure completion will be measured in minutes
Patient Satisfaction	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.	Measured with PSSI score. This consists of a questionnaire administered to the provider following the procedure with questions detailing different aspects of the procedure. Answers will be summed and the scores are normalized to a scale of 0-100 (high scores denote higher satisfaction). Criteria for discharge are at least 30 minutes elapsed since the last dose of sedative medication was administered, presence of protective reflexes (swallow and gag), stable vital signs, patient passes trial of ambulation (if was ambulating prior to procedure, a responsible adult is present to drive patient home and remain with the patient the length of two half-lives of the medications administered for sedation, and there are no staff concerns about safety. After the patient meets discharge criteria, a survey will be preformed. It will also be repeated once at the 48 hour post-procedure time. Conclusion of the two surveys concludes patient participation in the study.
Time to cecum (for colonoscopy)	During the procedure	Time required for endoscopist to reach the cecum, will be measured in minutes
Adverse events	During the procedure	Are detailed in the protocol. We will be recording the presence or absence of adverse events.
Need for additional medications, ie reversal agents	During the procedure	Will be measured as yes or no, specific dose and medication will be recorded for analysis.
Total dose of medications given	During the procedure	All doses of medications will be summed and reported.
Changes in vital signs	During the procedure	As defined in the protocol. We will be recording all vital signs for later analysis.

Trial Locations

Locations (1)

Brooke Army Medical Center; 🇺🇸 Fort Sam Houston, Texas, United States