Prophylaxy of Postoperative Nausea and Vomiting in Patients Undergoing Laparoscopic Surgery

Study Overview
=================
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.

Official Title
-----------------
Prophylaxy of Postoperative Nausea and Vomiting in Patients Undergoing Laparoscopic Surgery

Conditions
-----------------
Postoperative Complications, Postoperative Nausea and Vomiting

Intervention / Treatment
-----------------
* Drug: Group A - gabapentin 600 mg
* Drug: Group B - pregabalin
* Drug: Group C - placebo


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Anesthesia, Complications, Nausea, Vomiting