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

NCT ID: NCT02617121

Last Updated: 2015-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-30

Study Completion Date

2016-10-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Postoperative Nausea and Vomiting

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Gabapentin

oral gabapentin 300 mg 1 hours before induction of anesthesia

Group Type ACTIVE_COMPARATOR

Gabapentin

Intervention Type DRUG

oral gabapentin 300 mg 1 hour before induction of anesthesia

ramosetron

ramosetron 0.3 mg iv at end of surgery

Group Type ACTIVE_COMPARATOR

Ramosetron

Intervention Type DRUG

ramosetron 0.3 mg iv at end of surgery

Gabapentin and ramosetron

oral gabapentin 300 mg 1 hours before induction of anesthesia ramosetron 0.3 mg iv at end of surgery

Group Type ACTIVE_COMPARATOR

Gabapentin and Ramosetron

Intervention Type DRUG

oral gabapentin 300 mg 1 hour before induction of anesthesia and ramosetron 0.3 mg iv at end of surgery

Interventions

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Gabapentin

oral gabapentin 300 mg 1 hour before induction of anesthesia

Intervention Type DRUG

Ramosetron

ramosetron 0.3 mg iv at end of surgery

Intervention Type DRUG

Gabapentin and Ramosetron

oral gabapentin 300 mg 1 hour before induction of anesthesia and ramosetron 0.3 mg iv at end of surgery

Intervention Type DRUG

Other Intervention Names

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Neurontin Nasea Neurontin and Nasea

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Hallym University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hallym University Sacred Heart Hospital

Anyang-si, Gyeonggi-do, South Korea

Site Status

Countries

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South Korea

Central Contacts

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Kyung Mi Kim, M.D.

Role: CONTACT

Phone: +82-31-380-3945

Email: [email protected]

Soo Kyung Lee, Ph.D.

Role: CONTACT

Phone: +82-31-380-3945

Email: [email protected]

References

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Kim KM, Huh J, Lee SK, Park EY, Lee JM, Kim HJ. Combination of gabapentin and ramosetron for the prevention of postoperative nausea and vomiting after gynecologic laparoscopic surgery: a prospective randomized comparative study. BMC Anesthesiol. 2017 May 19;17(1):65. doi: 10.1186/s12871-017-0357-8.

Reference Type DERIVED
PMID: 28525981 (View on PubMed)

Other Identifiers

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HallymUMC

Identifier Type: -

Identifier Source: org_study_id