Prophylaxy of Postoperative Nausea and Vomiting in Patients Undergoing Laparoscopic Surgery

Postoperative Complications Clinical Trial

Official title:

Prophylaxy of Postoperative Nausea and Vomiting in Patients Undergoing Laparoscopic Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03202459
• Other study ID #: 56057116.0.0000.5479
• Status: Recruiting
• Phase: N/A
• First received: June 23, 2017
• Last updated: June 27, 2017
• Start date: March 2, 2017
• Est. completion date: January 31, 2018

Study information

• Verified date: June 2017
• Source: Faculdade de Ciências Médicas da Santa Casa de São Paulo
• Contact: Ligia Andrade da Silva Telles Mathias, Doctor
• Phone: + 55 11 99386-0059
• Email: rtimao[@]uol.com.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: January 31, 2018
• Est. primary completion date: September 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Nausea
• Postoperative Complications
• Postoperative Nausea and Vomiting
• Vomiting

Intervention

Drug:
• Group A - gabapentin 600 mg
The patient will receive oral 600 mg gabapentin 2 h before surgery
• Group B - pregabalin
The patient will receive oral pregabalin 150 mg 2 h before surgery
• Group C - placebo
The patient will receive oral placebo 2 h before surgery and ondansetron 8mg intravenous at the end of the surgery

Locations

Country	Name	City	State
Brazil	Irmandade da Santa Casa de Misericórdia de São Paulo	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Faculdade de Ciências Médicas da Santa Casa de São Paulo

Country where clinical trial is conducted

Brazil, 

References & Publications (4)

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. — View 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, Tramèr MR; Society for Ambulatory Anesthesia. Cons — View 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. — View 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 Me — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative Nausea or vomiting M0	The occurrence of postoperative nausea or vomiting, in the recovery room, during the first hour after surgery	1 hours
Primary	Postoperative Nausea or vomiting M12	The occurrence of postoperative nausea or vomiting, reported by the patient or witnessed by a healthcare provider during the first 12 hours after surgery	12 hours
Primary	Postoperative Nausea or vomiting M24	The occurrence of postoperative nausea or vomiting, reported by the patient or witnessed by a healthcare provider during the first 24 hours after surgery	24 hours
Primary	Postoperative Nausea or vomiting M48	The occurrence of postoperative nausea or vomiting, reported by the patient or witnessed by a healthcare provider during the first 48 hours after surgery	48 hours
Secondary	Patient demographic data	With a questionnaire will be studied the variables: age, sex, weight, height, BMI	Before surgery
Secondary	Surgical Duration	Time of surgery	First hour after surgery
Secondary	Duration of postoperative anesthesia stay	Time to postoperative anesthesia care unit discharge alive (hours)	First hours after surgery
Secondary	The length of stay in hospital	Time of stay in hospital	From end of surgery until hospital discharge or 30 days after surgery
Secondary	Time to request the first medication for nausea and vomiting	Reported by the patient or by a healthcare provider	First hour after surgery
Secondary	Amount of medication	Reported by a healthcare provider	During the first 30 days after surgery
Secondary	Postoperative complications	Postoperative complications after surgery	During the first 30 days after surgery
Secondary	Degree of patient satisfaction	The patient's overall satisfaction will be assessed using point scales (very satisfied, somewhat satisfied, neither satisfied nor dissatisfied, somewhat dissatisfied, very dissatisfied)	Before discharge