The Effects of Gabapentin and Ramosetron on Postoperative Nausea and Vomiting in Laparoscopic Gynecological Surgery

Study Overview
=================
Brief Summary
-----------------
This study was designed to compare the effects of gabapentin and ramosetron on PONV in patients undergoing laparoscopic gynecologic surgery.

Detailed Description
-----------------
Postoperative nausea and vomiting (PONV) in the postanesthesia care unit is a common occurrence after general anesthesia. And laparoscopic gynecological surgery is associated with a high incidence of PONV. Several antiemetic agents such as dopaminergic, histaminic and 5-HT3 antagonist (including ondansetron, ramosetron, granisetron) have been used to prevent PONV. Gabapentin, anti-convulsant, has been shown to decrease PONV, as well as chemotherapy induced nausea and vomiting in recent studies, although the exact mechanism against PONV is not known. The purpose of this study was to compare the efficacy of gabapentin and ramosetron in preventing PONV in patients undergoing laparoscopic gynecological surgery.

Official Title
-----------------
Comparison of the Prophylactic Anti-emetic Efficacy of Gabapentin and Ramosetron in Patients Undergoing Laparoscopic Gynecological Surgery

Conditions
-----------------
Postoperative Nausea and Vomiting

Intervention / Treatment
-----------------
* Drug: Gabapentin
* Drug: Ramosetron
* Drug: Gabapentin and Ramosetron


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with ASA physical status 1 and 2 between 20 and 65 years undergoing laparoscopic gynecological surgery with patient-controlled analgesia for postoperative pain control. Exclusion Criteria: Pregnant women Patients who took sedatives, antiemetics, hypnotics, analgesics, steroid, or gabapentin Patients with neurological deficits Patients with history of drug abuse and allergy of study drugs

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Gabapentin<br>oral gabapentin 300 mg 1 hours before induction of anesthesia | Drug: Gabapentin<br>* oral gabapentin 300 mg 1 hour before induction of anesthesia<br>* Other names: Neurontin;|
| Active Comparator: ramosetron<br>ramosetron 0.3 mg iv at end of surgery | Drug: Ramosetron<br>* ramosetron 0.3 mg iv at end of surgery<br>* Other names: Nasea;|
| Active Comparator: Gabapentin and ramosetron<br>oral gabapentin 300 mg 1 hours before induction of anesthesia ramosetron 0.3 mg iv at end of surgery | Drug: Gabapentin and Ramosetron<br>* oral gabapentin 300 mg 1 hour before induction of anesthesia and ramosetron 0.3 mg iv at end of surgery<br>* Other names: Neurontin and Nasea;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of postoperative nausea and vomiting | The incidence of postoperative nausea and vomiting will be assessed during 48 hours after surgery | 48 hours postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severity of nausea | The severity of nausea will be assessed using verbal rating scales (VRS 11-points scales: 0=no nausea to 10=nausea as bad as it could be) | 48 hours postoperative | 
| pain score | The pain score will be assessed using verbal rating scales (VRS 11-points scales: 0=none to 10=most severe) | 48 hours postoperative | 
| sedation score | The sedation score will be assessed using verbal rating scales (VRS 11-points scales:0=none to 10=most severe) | 48 hours postoperative | 
| patient's overall satisfaction score | The patient's overall satisfaction score will be assessed using 5 point scales (5=very satisfied, 4=somewhat satisfied, 3=neither satisfied nor dissatisfied, 2=somewhat dissatisfied, 1=very dissatisfied) | 48 hours postoperative | 
| side effects | The side effects such as somnolence, dizziness, headache, tremor, diplopia and nystagmus will be assessed and treated | 48 hours postoperative |