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Low Doses of Ketamine and Postoperative Quality of Recovery

NCT02571153 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 135

Last updated 2017-03-06

Study results available
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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).

Conditions

  • Postoperative Pain
  • Postoperative Nausea and Vomiting

Interventions

DRUG

Ketamine 0.4 mg/kg

Intravenous ketamine 0.4 mg/kg after induction of anesthesia

DRUG

Normal saline

Intravenous normal saline 0.9% 5 mL

DRUG

Ketamine 0.2 mg/kg

Intravenous ketamine 0.2 mg/kg after induction of anesthesia

Sponsors & Collaborators

  • Pontificia Universidade Catolica de Sao Paulo

    lead OTHER

Principal Investigators

  • Eduardo T Moro, PhD · School of Medical and Health Sciences, Pontificial Catholic University of São Paulo - PUCSP

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2016-03-31
Completion
2016-05-31

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02571153 on ClinicalTrials.gov