Status:
COMPLETED
Ketamine for Endoscopic Sedation in Outpatient Adult Endoscopy.
Lead Sponsor:
Brooke Army Medical Center
Conditions:
Administration and Dosage of Ketamine
Endoscopic Sedation
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
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 randomi...
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 sedati...
Eligibility Criteria
Inclusion
- Patients age 18 to 65 years who present to the GI clinic for an EGD or colonoscopy
Exclusion
- 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
Key Trial Info
Start Date :
March 5 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2019
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT03461718
Start Date
March 5 2018
End Date
October 1 2019
Last Update
July 8 2020
Active Locations (1)
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1
Brooke Army Medical Center
Fort Sam Houston, Texas, United States, 78234