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
About this trial
This is an interventional prevention trial for Postoperative Nausea and Vomiting
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
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
NCT ID
NCT02617121
First Posted
November 18, 2015
Last Updated
November 25, 2015
Sponsor
Hallym University Medical Center
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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