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Ketamine for Endoscopic Sedation in Outpatient Adult Endoscopy.

NCT03461718 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2020-07-08

No results posted yet for this study

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.

Conditions

  • Administration and Dosage of Ketamine
  • Endoscopic Sedation

Interventions

DRUG

Ketamine

Experimental arm for sedation.

DRUG

Midazolam injection

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

DRUG

Fentanyl

Part of standard sedation regimen

Sponsors & Collaborators

  • Brooke Army Medical Center

    lead FED

Principal Investigators

  • Jerome C Edelson, MD · BAMC

  • John G Gancayco, MD · BAMC

  • Cyrus V Edelson, MD · BAMC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-03-05
Primary Completion
2019-10-01
Completion
2019-10-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03461718 on ClinicalTrials.gov