Ketamine for Endoscopic Sedation in Outpatient Adult Endoscopy.

NCT ID: NCT03461718

Last Updated: 2020-07-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-05
• Study Completion Date: 2019-10-01

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.

Conditions

Administration and Dosage of Ketamine; Endoscopic Sedation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Ketamine

Intervention Type: DRUG

Experimental arm for sedation.

Midazolam injection

Intervention Type: DRUG

Part of standard sedation regimen and anxiolysis and for minimization of emergence reaction

Control

This group will receive midazolam and fentanyl alternated as currently preformed for endoscopy.

Group Type: ACTIVE_COMPARATOR

Midazolam injection

Intervention Type: DRUG

Part of standard sedation regimen and anxiolysis and for minimization of emergence reaction

Fentanyl

Intervention Type: DRUG

Part of standard sedation regimen

Interventions

Ketamine

Experimental arm for sedation.

Intervention Type: DRUG

Midazolam injection

Part of standard sedation regimen and anxiolysis and for minimization of emergence reaction

Intervention Type: DRUG

Fentanyl

Part of standard sedation regimen

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Brooke Army Medical Center

FED

Sponsor Role: lead

Responsible Party

Jerome Edelson

Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jerome C Edelson, MD

Role: PRINCIPAL_INVESTIGATOR

BAMC

John G Gancayco, MD

Role: STUDY_CHAIR

BAMC

Cyrus V Edelson, MD

Role: STUDY_DIRECTOR

BAMC

Locations

Brooke Army Medical Center

Fort Sam Houston, Texas, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 35796486 (View on PubMed)

Other Identifiers

C.2017.175

Identifier Type: -

Identifier Source: org_study_id