Prophylaxy of Postoperative Nausea and Vomiting in Patients Undergoing Laparoscopic Surgery

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.

Study Overview

• Status: Unknown
• Conditions: Postoperative Complications; Postoperative Nausea and Vomiting
• Intervention / Treatment: Drug: Group A - gabapentin 600 mg; Drug: Group B - pregabalin; Drug: Group C - placebo

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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • São Paulo, Brazil, 01221-020
    • Recruiting
    • Irmandade Da Santa Casa De Misericordia De Sao Paulo
    • Contact: Thiago Ramos Grigio, Master; Phone Number: +55 11 99298-1605; Email: grigiotr@gmail.com
    • Principal Investigator: Ligia Andrade da Silva Telles Mathias, Doctor
    • Sub-Investigator: Patrícia Mara Beltrame, Medical Residency
    • Sub-Investigator: Rodolfo Brito Maia, Medical Residency
    • Sub-Investigator: Paulo Henrique Borges Teixeira Lima, Medical Residency

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Active Comparator: Group A - gabapentin; The patient will receive oral 600 mg gabapentin 2 h before surgery	Drug: Group A - gabapentin 600 mg; The patient will receive oral 600 mg gabapentin 2 h before surgery
Active Comparator: Active Comparator: Group B - pregabalin; The patient will receive oral pregabalin 150 mg 2 h before surgery	Drug: Group B - pregabalin; The patient will receive oral pregabalin 150 mg 2 h before surgery
Placebo Comparator: 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	Drug: Group C - placebo; The patient will receive oral placebo 2 h before surgery and ondansetron 8mg intravenous at the end of the surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative Nausea or vomiting M0	The occurrence of postoperative nausea or vomiting, in the recovery room, during the first hour after surgery	1 hours
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient demographic data	With a questionnaire will be studied the variables: age, sex, weight, height, BMI	Before surgery
Surgical Duration	Time of surgery	First hour after surgery
Duration of postoperative anesthesia stay	Time to postoperative anesthesia care unit discharge alive (hours)	First hours after surgery
The length of stay in hospital	Time of stay in hospital	From end of surgery until hospital discharge or 30 days after surgery
Time to request the first medication for nausea and vomiting	Reported by the patient or by a healthcare provider	First hour after surgery
Amount of medication	Reported by a healthcare provider	During the first 30 days after surgery
Postoperative complications	Postoperative complications after surgery	During the first 30 days after surgery
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

Collaborators and Investigators

• Sponsor: Faculdade de Ciências Médicas da Santa Casa de São Paulo

Publications and helpful links

General Publications

• 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. Erratum In: Anesth Analg. 2014 Mar;118(3):689. Anesth Analg. 2015 Feb;120(2):494.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 2, 2017
• Primary Completion (Anticipated): September 30, 2017
• Study Completion (Anticipated): January 31, 2018

Study Registration Dates

• First Submitted: June 23, 2017
• First Submitted That Met QC Criteria: June 27, 2017
• First Posted (Actual): June 28, 2017

Study Record Updates

• Last Update Posted (Actual): June 28, 2017
• Last Update Submitted That Met QC Criteria: June 27, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: Nausea; Vomiting; Complications; Anesthesia
• Additional Relevant MeSH Terms: Pathologic Processes; Signs and Symptoms, Digestive; Nausea; Vomiting; Postoperative Complications; Postoperative Nausea and Vomiting; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Tranquilizing Agents; Psychotropic Drugs; Membrane Transport Modulators; Anti-Anxiety Agents; Anticonvulsants; Antimanic Agents; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Gabapentin; Pregabalin
• Other Study ID Numbers: 56057116.0.0000.5479

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No