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

Not Applicable

• Conditions: Postoperative Nausea and Vomiting
• Interventions: Drug: Gabapentin and Ramosetron; Drug: Ramosetron; Drug: Gabapentin

• Registration Number: NCT02617121
• Lead Sponsor: Hallym University Medical Center

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.

Study Timeline

• Status Verified: 2015-11
• Study Start: 2015-11
• Study First Submitted: 2015-11-18
• Study First Submitted QC: 2015-11-25
• Last Update Submitted: 2015-11-25
• Study First Posted: 2015-11-30
• Last Update Posted: 2015-11-30
• Primary Completion: 2016-08
• Study Completion: 2016-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Gabapentin and ramosetron	Gabapentin and Ramosetron	oral gabapentin 300 mg 1 hours before induction of anesthesia ramosetron 0.3 mg iv at end of surgery
ramosetron	Ramosetron	ramosetron 0.3 mg iv at end of surgery
Gabapentin	Gabapentin	oral gabapentin 300 mg 1 hours before induction of anesthesia

Primary Outcome Measures

Name	Time	Method
Incidence of postoperative nausea and vomiting	48 hours postoperative	The incidence of postoperative nausea and vomiting will be assessed during 48 hours after surgery

Secondary Outcome Measures

Name	Time	Method
sedation score	48 hours postoperative	The sedation score will be assessed using verbal rating scales (VRS 11-points scales:0=none to 10=most severe)
patient's overall satisfaction score	48 hours postoperative	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)
side effects	48 hours postoperative	The side effects such as somnolence, dizziness, headache, tremor, diplopia and nystagmus will be assessed and treated
pain score	48 hours postoperative	The pain score will be assessed using verbal rating scales (VRS 11-points scales: 0=none to 10=most severe)
Severity of nausea	48 hours postoperative	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)

Trial Locations

Locations (1)

Hallym University Sacred Heart Hospital; 🇰🇷 Anyang-si, Gyeonggi-do, Korea, Republic of