Ketamine for Endoscopic Sedation in Outpatient Adult Endoscopy.

Ketamine as a Sedation Adjunct for Endoscopic Procedures

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.

Study Overview

• Status: Completed
• Conditions: Administration and Dosage of Ketamine; Endoscopic Sedation
• Intervention / Treatment: Drug: Ketamine; Drug: Midazolam injection; Drug: Fentanyl

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 Type: Interventional
• Enrollment (Actual): 66
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Texas
    • Fort Sam Houston, Texas, United States, 78234
      • Brooke Army Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	Drug: Ketamine; Experimental arm for sedation.; Drug: Midazolam injection; Part of standard sedation regimen and anxiolysis and for minimization of emergence reaction
ACTIVE_COMPARATOR: Control; This group will receive midazolam and fentanyl alternated as currently preformed for endoscopy.	Drug: Midazolam injection; Part of standard sedation regimen and anxiolysis and for minimization of emergence reaction; Drug: Fentanyl; Part of standard sedation regimen

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Provider satisfaction	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).	Measured within 15 minutes post proceudre

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sedation time	Time from sedation administration until procedure start, will be measured in minutes	During the procedure
Time to cecum (for colonoscopy)	Time required for endoscopist to reach the cecum, will be measured in minutes	During the procedure
Total dose of medications given	All doses of medications will be summed and reported.	During the procedure
Overall procedure time	The time from procedure start to procedure completion will be measured in minutes	During the procedure
Adverse events	Are detailed in the protocol. We will be recording the presence or absence of adverse events.	During the procedure
Changes in vital signs	As defined in the protocol. We will be recording all vital signs for later analysis.	During the procedure
Need for additional medications, ie reversal agents	Will be measured as yes or no, specific dose and medication will be recorded for analysis.	During the procedure
Patient Satisfaction	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.	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.

Collaborators and Investigators

• Sponsor: Brooke Army Medical Center
• Investigators: Principal Investigator: Jerome C Edelson, MD, BAMC; Study Chair: John G Gancayco, MD, BAMC; Study Director: Cyrus V Edelson, MD, BAMC

Publications and helpful links

General Publications

• 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. 2022 Jul 7:usac183. doi: 10.1093/milmed/usac183. Online ahead of print.

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 5, 2018
• Primary Completion (ACTUAL): October 1, 2019
• Study Completion (ACTUAL): October 1, 2019

Study Registration Dates

• First Submitted: February 23, 2018
• First Submitted That Met QC Criteria: March 9, 2018
• First Posted (ACTUAL): March 12, 2018

Study Record Updates

• Last Update Posted (ACTUAL): July 8, 2020
• Last Update Submitted That Met QC Criteria: July 7, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Dissociative; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Analgesics, Opioid; Narcotics; Tranquilizing Agents; Psychotropic Drugs; Hypnotics and Sedatives; Adjuvants, Anesthesia; Anti-Anxiety Agents; GABA Modulators; GABA Agents; Ketamine; Fentanyl; Midazolam
• Other Study ID Numbers: C.2017.175

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No