Skip to content
CompletedPhase 2 / Phase 3Results posted

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

NCT02452060 · NYU Langone Health

Closed to entry
Status
Not accepting participants
Phase 2 / Phase 3
Phase
90
Target enrolment
1
Study sites
1 US states

What it is testing

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.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Change in Pain Scores

    Measured over Baseline (DOS) to 7 days (Post Op)

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years to 65 Years
Ages
All
Sex
Not accepted
Healthy volunteers
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

Where

1 study site

FacilityCityRegionCountry
NYU Langone Medical CenterNew YorkNew YorkUnited States

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT02452060 on ClinicalTrials.gov →

Last updated in the registry 2020-03-16. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits