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

H

Hallym University

Status

Unknown

Conditions

Postoperative Nausea and Vomiting

Treatments

Drug: Ramosetron
Drug: Gabapentin
Drug: Gabapentin and Ramosetron

Study type

Interventional

Funder types

Other

Identifiers

NCT02617121
HallymUMC

Details and patient eligibility

About

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

Full 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.

Enrollment

120 estimated patients

Sex

Female

Ages

20 to 65 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

120 participants in 3 patient groups

Gabapentin
Active Comparator group
Description:
oral gabapentin 300 mg 1 hours before induction of anesthesia
Treatment:
Drug: Gabapentin
ramosetron
Active Comparator group
Description:
ramosetron 0.3 mg iv at end of surgery
Treatment:
Drug: Ramosetron
Gabapentin and ramosetron
Active Comparator group
Description:
oral gabapentin 300 mg 1 hours before induction of anesthesia ramosetron 0.3 mg iv at end of surgery
Treatment:
Drug: Gabapentin and Ramosetron

Trial contacts and locations

1

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Central trial contact

Kyung Mi Kim, M.D.; Soo Kyung Lee, Ph.D.

Data sourced from clinicaltrials.gov

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