CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 135 enrolled
Drug / intervention
Ketamine 0.4 mg/kg +2 moredrug
Likely dose
Ketamine 0.4 mg/kgfrom record
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Search/NCT02571153
NCT02571153Phase 4Completed

Effects of Low Doses of Ketamine on Postoperative Quality of Recovery After Total Intravenous Anesthesia

Pontificia Universidade Catolica de Sao Paulo·interventional·Posted Oct 8, 2015·Updated Mar 6, 2017

In Brief

A Phase 4 clinical trial evaluating Ketamine 0.4 mg/kg, Normal saline, and 1 other intervention for Postoperative Pain and Postoperative Nausea and Vomiting. Completed, enrolled 135 participants across 1 site.

Detailed Summary

There are evidences that intraoperative administration of low doses of ketamine may contribute to control the postoperative pain by acting on the N-methyl-D-aspartate (NMDA) channel, reducing the effects related to the tolerance and hyperalgesia induced by opioids. This study aims to evaluate the effects of administration of this agent not only as an analgesic but also its role in the quality of recovery from anesthesia, which includes observation of emotional, psychological and physical aspects. Patients who were scheduled to undergo total intravenous anesthesia (TIVA) for laparoscopic cholecystectomy will be enrolled in this clinical study. After induction of anesthesia, patients will receive one of three solutions according to the randomly selected group: ketamine 0,2 mg/kg; ketamine 0,4 mg/kg or saline. In the recovery room and on the ward, data related to the presence of pain, analgesic consumption, the incidence of nausea and vomiting, dizziness or hallucinations will be recorded. The next day, the quality of recovery will be evaluated by application of the questionnaire QoR40 (Quality of Recovery Questionnaire-40).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBrazil
Collaborators--

Timeline

Phase 4CompletedFinished
20162017201820192020202120222023202420252026
First PostedOct 8, 2015
Enrollment StartSep 1, 2015
Primary CompletionMar 1, 2016
Study CompletionMay 1, 2016
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 10.7 years ago

Interventions

Ketamine 0.4 mg/kgdrug

Intravenous ketamine 0.4 mg/kg after induction of anesthesia

Normal salinedrug

Intravenous normal saline 0.9% 5 mL

Ketamine 0.2 mg/kgdrug

Intravenous ketamine 0.2 mg/kg after induction of anesthesia