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

November 25, 2015 updated by: Hallym University Medical Center

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

This study was designed to compare the effects of gabapentin and ramosetron on PONV in patients undergoing laparoscopic gynecologic surgery.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Korea, Republic of
    • Gyeonggi-do
      • Anyang-si, Gyeonggi-do, Korea, Republic of, KS009
        • Hallym University Sacred Heart Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Gabapentin
oral gabapentin 300 mg 1 hours before induction of anesthesia
Drug: Gabapentin
oral gabapentin 300 mg 1 hour before induction of anesthesia
Other Names:
  • Neurontin
Active Comparator: ramosetron
ramosetron 0.3 mg iv at end of surgery
Drug: Ramosetron
ramosetron 0.3 mg iv at end of surgery
Other Names:
  • Nasea
Active Comparator: Gabapentin and ramosetron
oral gabapentin 300 mg 1 hours before induction of anesthesia ramosetron 0.3 mg iv at end of surgery
Drug: Gabapentin and Ramosetron
oral gabapentin 300 mg 1 hour before induction of anesthesia and ramosetron 0.3 mg iv at end of surgery
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
Time Frame: 48 hours postoperative
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
Time Frame: 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)
48 hours postoperative
pain score
Time Frame: 48 hours postoperative
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
Time Frame: 48 hours postoperative
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
Time Frame: 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)
48 hours postoperative
side effects
Time Frame: 48 hours postoperative
The side effects such as somnolence, dizziness, headache, tremor, diplopia and nystagmus will be assessed and treated
48 hours postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hallym University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2015

Primary Completion (Anticipated)

August 1, 2016

Study Completion (Anticipated)

October 1, 2016

Study Registration Dates

First Submitted

November 18, 2015

First Submitted That Met QC Criteria

November 25, 2015

First Posted (Estimate)

November 30, 2015

Study Record Updates

Last Update Posted (Estimate)

November 30, 2015

Last Update Submitted That Met QC Criteria

November 25, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HallymUMC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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