Ketamine for Endoscopic Sedation in Outpatient Adult Endoscopy.
Completed · Phase 2
Conditions studied: Administration and Dosage of Ketamine, Endoscopic Sedation
In brief
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.
Key facts
- Study ID
- NCT03461718
- Run by
- Brooke Army Medical Center
- People needed
- 66
- Starts
- 2018-03-05
- Expected to finish
- 2019-10-01
- Last updated by the study team
- 2020-07-08
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Patients age 18 to 65 years who present to the GI clinic for an EGD or colonoscopy
You may not qualify if…
- 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
Where it is running
- Brooke Army Medical Center — Fort Sam Houston, Texas, United States
Full record on ClinicalTrials.gov
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