Overview
Study on the Use of Low Dose Ketamine After Gastric Bypass and Gastrectomy
Status:
Completed
Completed
Trial end date:
2017-04-13
2017-04-13
Target enrollment:
0
0
Participant gender:
All
All
Summary
This is a randomized, double-blind, placebo-controlled, two-arm parallel, single-center study. One hundred subjects (50 in each arm) will be enrolled. Subjects, between the ages 18 and 65, undergoing laparoscopic gastric bypass or sleeve gastrectomy will be recruited and consented during the preadmission visit prior to surgery.Phase:
Phase 2/Phase 3Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
New York University School of Medicine
NYU Langone HealthTreatments:
Ketamine
Criteria
Inclusion Criteria:1. Adults, >18 years, <65 years, who will undergo gastric bypass or sleeve gastrectomy.
2. Subject is non-lactating and is either:
- Not of childbearing potential; or
- Of childbearing potential but is not pregnant at time of baseline as determined
by pre-operative pregnancy testing.
3. Subject is ASA physical status 1, 2, or 3.
4. Subject who is deemed medically stable
Exclusion Criteria:
1. <18 years of age; >65 years of age
2. Pregnant or breastfeeding
3. Does not speak or understand English (the study forms used are copy-righted in
English)
4. Cognitively impairment (by history) or clinical signs of altered mental status
5. History of misuse or abuse of ketamine
6. History of chest pain or chest pain in the PACU
7. Use of a medication that interferes with metabolism of ketamine within the last 24
hours
8. A diagnosis of schizophrenia and/ or a history of chronic antipsychotic medication use
9. History of head trauma
10. History of intracranial mass or hemorrhage
11. History of stroke
12. History of cardiac arrhythmia
13. Subject for whom ketamine is contraindicated
14. Unwillingness to give informed consent according to HIC guidelines