Ketamine for Endoscopic Sedation in Outpatient Adult Endoscopy.

• Status: Completed
• Trial end date: 2019-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Brooke Army Medical Center
• Treatments: Fentanyl; Ketamine; Midazolam

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