Prophylaxy of Postoperative Nausea and Vomiting in Patients Undergoing Laparoscopic Surgery

Faculdade de Ciências Médicas da Santa Casa de São Paulo

Status: Unknown

Conditions: Postoperative Complications; Postoperative Nausea and Vomiting

Treatments: Drug: Group C - placebo; Drug: Group B - pregabalin; Drug: Group A - gabapentin 600 mg

Study type: Interventional

Funder types: Other

Identifiers

NCT03202459

56057116.0.0000.5479

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 3 patient groups, including a placebo group

Active Comparator: Group A - gabapentin

Active Comparator group

Description:

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

Treatment:

Drug: Group A - gabapentin 600 mg

Active Comparator: Group B - pregabalin

Active Comparator group

Description:

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

Treatment:

Drug: Group B - pregabalin

Placebo Comparator: Group C - placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Group C - placebo