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

Postoperative Nausea and Vomiting Clinical Trial

— PONV  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02617121
• Other study ID #: HallymUMC
• Status: Not yet recruiting
• Phase: N/A
• First received: November 18, 2015
• Last updated: November 25, 2015
• Start date: November 2015
• Est. completion date: October 2016

Study information

• Verified date: November 2015
• Source: Hallym University Medical Center
• Contact: Kyung Mi Kim, M.D.
• Phone: +82-31-380-3945
• Email: sumsonyo[@]hallym.or.kr
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: October 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Nausea
• Postoperative Nausea and Vomiting
• Vomiting

Intervention

Drug:
• Gabapentin
oral gabapentin 300 mg 1 hour before induction of anesthesia
• Ramosetron
ramosetron 0.3 mg iv at end of surgery
• Gabapentin and Ramosetron
oral gabapentin 300 mg 1 hour before induction of anesthesia and ramosetron 0.3 mg iv at end of surgery

Locations

Country	Name	City	State
Korea, Republic of	Hallym University Sacred Heart Hospital	Anyang-si	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Hallym University Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of postoperative nausea and vomiting	The incidence of postoperative nausea and vomiting will be assessed during 48 hours after surgery	48 hours postoperative	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	No
Secondary	side effects	The side effects such as somnolence, dizziness, headache, tremor, diplopia and nystagmus will be assessed and treated	48 hours postoperative	Yes