Prophylaxy of Postoperative Nausea and Vomiting in Patients Undergoing Laparoscopic Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-02

Study Completion Date

2018-01-31

Brief Summary

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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.

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Detailed Description

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The study included 60 patients at high risk for PONV (Apfel-score 0, I, II, III and IV) scheduled for elective laparoscopic surgeries at the Central Surgical Center of Irmandade da Santa Casa de Misericórdia in São Paulo. Inclusion criteria will be ASA I or II of either sex, in the age range of 18 to 70 years. In this study, the recruited patients will be allocated randomly into three groups. The group A will receive oral 600 mg gabapentin 2 h before surgery. The group B will receive oral 150 mg pregabalin 2 h before surgery. The Group C will receive oral placebo 2 h before surgery and ondansetron 8mg intravenous at the end of the surgery. This study is "double-blind", in which neither the doctor nor the patient knows what medicine is being given.

Conditions

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Postoperative Complications Postoperative Nausea and Vomiting

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Active Comparator: Group A - gabapentin

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

Group Type ACTIVE_COMPARATOR

Group A - gabapentin 600 mg

Intervention Type DRUG

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

Active Comparator: Group B - pregabalin

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

Group Type ACTIVE_COMPARATOR

Group B - pregabalin

Intervention Type DRUG

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

Placebo Comparator: Group C - placebo

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

Group Type PLACEBO_COMPARATOR

Group C - placebo

Intervention Type DRUG

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

Interventions

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Group A - gabapentin 600 mg

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

Intervention Type DRUG

Group B - pregabalin

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

Intervention Type DRUG

Group C - placebo

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients undergoing laparoscopic procedures
* Apfel Score 0, I, II, III and IV
* ASA I / II

Exclusion Criteria

* Patients with surgery converted to open before thirty minutes of surgery
* Patients who were exposed previously to gabapentin or pregabalin Patients who have allergy to any medicine used in the study
* Patient who have to any cognitive impairment
* Illiterate patients
* Patients who refuse to participate in the study

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No