Phase 3
Completed N=90
Study on the Use of Low Dose Ketamine After Gastric Bypass and Gastrectomy
Postoperative Pain · Postoperative Depression
Source: ClinicalTrials.gov NCT02452060 ↗
Enrolled (actual)
90
Serious AEs
0.0%
Results posted
Mar 2020
Primary outcomePrimary: Change in Pain Scores — 1.45; 1 score on a scale
◆ Published Evidence
Established
45citations · ~6 / year
Effects of a single subanaesthetic dose of ketamine on pain and mood after laparoscopic bariatric surgery: A randomised double-blind placebo controlled study.
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.
Linked Publications
-
Effects of a single subanaesthetic dose of ketamine on pain and mood after laparoscopic bariatric surgery: A randomised double-blind placebo controlled study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Pain Scores |
1.45; 1 | — |
| SECONDARY Length of Stay During Hospitalization |
1.3; 1.2 | — |
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
Data sourced from ClinicalTrials.gov (NCT02452060) and the linked publication. 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. Informational only — not medical advice.