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

Completed · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Pain, Postoperative Depression

In brief

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.

Key facts

Study ID

NCT02452060

Run by

NYU Langone Health

People needed

90

Starts

2014-10-01

Expected to finish

2017-04-13

Last updated by the study team

2020-03-16

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adults, >18 years, <65 years, who will undergo gastric bypass or sleeve gastrectomy.
• 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.
• Subject is ASA physical status 1, 2, or 3.
• Subject who is deemed medically stable

You may not qualify if…

• <18 years of age; >65 years of age
• Pregnant or breastfeeding
• Does not speak or understand English (the study forms used are copy-righted in English)
• Cognitively impairment (by history) or clinical signs of altered mental status
• History of misuse or abuse of ketamine
• History of chest pain or chest pain in the PACU
• Use of a medication that interferes with metabolism of ketamine within the last 24 hours
• A diagnosis of schizophrenia and/ or a history of chronic antipsychotic medication use
• History of head trauma
• History of intracranial mass or hemorrhage
• History of stroke
• History of cardiac arrhythmia
• Subject for whom ketamine is contraindicated
• Unwillingness to give informed consent according to HIC guidelines

Where it is running

• NYU Langone Medical Center — New York, New York, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.