NCT03202459

Prophylaxy of Postoperative Nausea and Vomiting in Patients Undergoing Laparoscopic Surgery

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Faculdade de Ciências Médicas da Santa Casa de São Paulo · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Postoperative Complications
• Postoperative Nausea and Vomiting

Interventions

Type	Name	Description
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

Timeline

• Start date: 2017-03-02
• Primary completion: 2017-09-30
• Completion: 2018-01-31
• First posted: 2017-06-28
• Last updated: 2017-06-28

Locations

1 site across 1 country: Brazil