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Prophylaxy of Postoperative Nausea and Vomiting in Patients Undergoing Laparoscopic Surgery

NCT03202459 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2017-06-28

No results posted yet for this study

Summary

Postoperative nausea and vomiting (PONV) is one of the most commonly reported adverse effects of anesthesia. The general incidence of vomiting is approximately 30%, nausea at 50% and the PONV rate can go up to 80% in high-risk patients without prophylaxis. Prevention of these episodes in high-risk patients improves satisfaction and well-being rates. Therefore, it becomes important the adequate control of PONV, aiming at the satisfaction of the patient with the procedure, lower costs for the health system as well as reduction of complications in the postoperative period. This study aims to evaluate the association of gabapentin or pregabalin with dexamethasone in reducing the incidence of PONV in high-risk patients undergoing laparoscopic surgeries in the first 48 hours postoperatively as well as to assess side effects.

Conditions

  • Postoperative Complications
  • Postoperative Nausea and Vomiting

Interventions

DRUG

Group A - gabapentin 600 mg

The patient will receive oral 600 mg gabapentin 2 h before surgery

DRUG

Group B - pregabalin

The patient will receive oral pregabalin 150 mg 2 h before surgery

DRUG

Group C - placebo

The patient will receive oral placebo 2 h before surgery and ondansetron 8mg intravenous at the end of the surgery

Sponsors & Collaborators

  • Faculdade de Ciências Médicas da Santa Casa de São Paulo

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2017-03-02
Primary Completion
2017-09-30
Completion
2018-01-31

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 NCT03202459 on ClinicalTrials.gov