Study on the Use of Low Dose Ketamine After Gastric Bypass and Gastrectomy

• Status: Completed
• Trial end date: 2017-04-13
• Target enrollment: 0
• Participant gender: 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 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: New York University School of Medicine; NYU Langone Health
• Treatments: 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