Phase 3 N=90 Randomized Triple-blind Treatment

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

Pain · Postoperative Depression

Bottom Line

View on ClinicalTrials.gov: NCT02452060 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2020

Primary outcome: Primary: Change in Pain Scores — 1.45; 1 score on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Ketamine (Drug); Placebo Comparator (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: NYU Langone Health
Primary completion: Apr 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Pain Scores	1.45; 1	—
SECONDARY Length of Stay During Hospitalization	1.3; 1.2	—

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.

Eligibility Criteria

Inclusion Criteria

Adults, >18 years, 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02452060). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.