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

Primary Purpose

Postoperative Nausea and Vomiting

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Gabapentin
Ramosetron
Gabapentin and Ramosetron
Sponsored by
Hallym University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Nausea and Vomiting

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)FemaleAccepts 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

Sites / Locations

  • Hallym University Sacred Heart Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Gabapentin

ramosetron

Gabapentin and ramosetron

Arm Description

oral gabapentin 300 mg 1 hours before induction of anesthesia

ramosetron 0.3 mg iv at end of surgery

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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)
pain score
The pain score will be assessed using verbal rating scales (VRS 11-points scales: 0=none to 10=most severe)
sedation score
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
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
The side effects such as somnolence, dizziness, headache, tremor, diplopia and nystagmus will be assessed and treated

Full Information

First Posted
November 18, 2015
Last Updated
November 25, 2015
Sponsor
Hallym University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02617121
Brief Title
The Effects of Gabapentin and Ramosetron on Postoperative Nausea and Vomiting in Laparoscopic Gynecological Surgery
Acronym
PONV
Official Title
Comparison of the Prophylactic Anti-emetic Efficacy of Gabapentin and Ramosetron in Patients Undergoing Laparoscopic Gynecological Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Unknown status
Study Start Date
November 2015 (undefined)
Primary Completion Date
August 2016 (Anticipated)
Study Completion Date
October 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hallym University Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Nausea and Vomiting

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Gabapentin
Arm Type
Active Comparator
Arm Description
oral gabapentin 300 mg 1 hours before induction of anesthesia
Arm Title
ramosetron
Arm Type
Active Comparator
Arm Description
ramosetron 0.3 mg iv at end of surgery
Arm Title
Gabapentin and ramosetron
Arm Type
Active Comparator
Arm Description
oral gabapentin 300 mg 1 hours before induction of anesthesia ramosetron 0.3 mg iv at end of surgery
Intervention Type
Drug
Intervention Name(s)
Gabapentin
Other Intervention Name(s)
Neurontin
Intervention Description
oral gabapentin 300 mg 1 hour before induction of anesthesia
Intervention Type
Drug
Intervention Name(s)
Ramosetron
Other Intervention Name(s)
Nasea
Intervention Description
ramosetron 0.3 mg iv at end of surgery
Intervention Type
Drug
Intervention Name(s)
Gabapentin and Ramosetron
Other Intervention Name(s)
Neurontin and Nasea
Intervention Description
oral gabapentin 300 mg 1 hour before induction of anesthesia and ramosetron 0.3 mg iv at end of surgery
Primary Outcome Measure Information:
Title
Incidence of postoperative nausea and vomiting
Description
The incidence of postoperative nausea and vomiting will be assessed during 48 hours after surgery
Time Frame
48 hours postoperative
Secondary Outcome Measure Information:
Title
Severity of nausea
Description
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)
Time Frame
48 hours postoperative
Title
pain score
Description
The pain score will be assessed using verbal rating scales (VRS 11-points scales: 0=none to 10=most severe)
Time Frame
48 hours postoperative
Title
sedation score
Description
The sedation score will be assessed using verbal rating scales (VRS 11-points scales:0=none to 10=most severe)
Time Frame
48 hours postoperative
Title
patient's overall satisfaction score
Description
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)
Time Frame
48 hours postoperative
Title
side effects
Description
The side effects such as somnolence, dizziness, headache, tremor, diplopia and nystagmus will be assessed and treated
Time Frame
48 hours postoperative

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kyung Mi Kim, M.D.
Phone
+82-31-380-3945
Email
sumsonyo@hallym.or.kr
First Name & Middle Initial & Last Name or Official Title & Degree
Soo Kyung Lee, Ph.D.
Phone
+82-31-380-3945
Email
agneta@hallym.or.kr
Facility Information:
Facility Name
Hallym University Sacred Heart Hospital
City
Anyang-si
State/Province
Gyeonggi-do
ZIP/Postal Code
KS009
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
28525981
Citation
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.
Results Reference
derived

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

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