At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 90 enrolled
Drug / intervention
Ketamine +1 moredrug
Likely dose
Ketamine 0.4mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Randomized, Double-blind, Placebo Controlled Study on the Effect of a Single Postoperative Administration of Low Dose Ketamine After Gastric Bypass and Gastrectomy Surgeries
In Brief
A Phase 3 clinical trial evaluating Ketamine and Placebo Comparator for Pain and Postoperative Depression. Completed, enrolled 90 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPain, Postoperative Depression
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
Enrollment StartOct 2014
First PostedMay 2015
Primary CompletionApr 2017
TodayJul 2026
First PostedMay 22, 2015
Enrollment StartOct 1, 2014
Primary CompletionApr 13, 2017
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 11.1 years ago
Interventions
Ketaminedrug
0.4mg/kg infusion
Placebo Comparatorother
0.4mg/kg infusion