Clinical trial NCT03202459: Prophylaxy of Postoperative Nausea and Vomiting in Patients Undergoing Laparoscopic Surgery
Official title: Prophylaxy of Postoperative Nausea and Vomiting in Patients Undergoing Laparoscopic Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Postoperative Complications
Postoperative Nausea and Vomiting
Keywords: Anesthesia
Complications
Nausea
Vomiting
Lead sponsor: Faculdade de Ciências Médicas da Santa Casa de São Paulo
Sponsor class: OTHER
First posted: 2017-06-28
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Postoperative Nausea or vomiting M0
timeFrame: 1 hours
measure: Postoperative Nausea or vomiting M12
timeFrame: 12 hours
measure: Postoperative Nausea or vomiting M24
timeFrame: 24 hours
measure: Postoperative Nausea or vomiting M48
timeFrame: 48 hours
Secondary outcomes:
measure: Patient demographic data
timeFrame: Before surgery
measure: Surgical Duration
timeFrame: First hour after surgery
measure: Duration of postoperative anesthesia stay
timeFrame: First hours after surgery
measure: The length of stay in hospital
timeFrame: From end of surgery until hospital discharge or 30 days after surgery
measure: Time to request the first medication for nausea and vomiting
timeFrame: First hour after surgery
measure: Amount of medication
timeFrame: During the first 30 days after surgery
measure: Postoperative complications
timeFrame: During the first 30 days after surgery
measure: Degree of patient satisfaction
timeFrame: Before discharge
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Irmandade da Santa Casa de Misericórdia de São Paulo
Study officials:
References:
citation: Gan TJ, Diemunsch P, Habib AS, Kovac A, Kranke P, Meyer TA, Watcha M, Chung F, Angus S, Apfel CC, Bergese SD, Candiotti KA, Chan MT, Davis PJ, Hooper VD, Lagoo-Deenadayalan S, Myles P, Nezat G, Philip BK, Tramer MR; Society for Ambulatory Anesthesia. Consensus guidelines for the management of postoperative nausea and vomiting. Anesth Analg. 2014 Jan;118(1):85-113. doi: 10.1213/ANE.0000000000000002.
citation: Pandey CK, Priye S, Ambesh SP, Singh S, Singh U, Singh PK. Prophylactic gabapentin for prevention of postoperative nausea and vomiting in patients undergoing laparoscopic cholecystectomy: a randomized, double-blind, placebo-controlled study. J Postgrad Med. 2006 Apr-Jun;52(2):97-100.
citation: Grant MC, Lee H, Page AJ, Hobson D, Wick E, Wu CL. The Effect of Preoperative Gabapentin on Postoperative Nausea and Vomiting: A Meta-Analysis. Anesth Analg. 2016 Apr;122(4):976-85. doi: 10.1213/ANE.0000000000001120.
citation: Chandrakantan A, Glass PS. Multimodal therapies for postoperative nausea and vomiting, and pain. Br J Anaesth. 2011 Dec;107 Suppl 1:i27-40. doi: 10.1093/bja/aer358.