The Effects of Gabapentin and Ramosetron on Postoperative Nausea and Vomiting in Laparoscopic Gynecological Surgery
PONV
Comparison of the Prophylactic Anti-emetic Efficacy of Gabapentin and Ramosetron in Patients Undergoing Laparoscopic Gynecological Surgery
1 other identifier
interventional
120
1 country
1
Brief Summary
This study was designed to compare the effects of gabapentin and ramosetron on PONV in patients undergoing laparoscopic gynecologic surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2015
CompletedFirst Submitted
Initial submission to the registry
November 18, 2015
CompletedFirst Posted
Study publicly available on registry
November 30, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2016
CompletedNovember 30, 2015
November 1, 2015
9 months
November 18, 2015
November 25, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Incidence of postoperative nausea and vomiting
The incidence of postoperative nausea and vomiting will be assessed during 48 hours after surgery
48 hours postoperative
Secondary Outcomes (5)
Severity of nausea
48 hours postoperative
pain score
48 hours postoperative
sedation score
48 hours postoperative
patient's overall satisfaction score
48 hours postoperative
side effects
48 hours postoperative
Study Arms (3)
Gabapentin
ACTIVE COMPARATORoral gabapentin 300 mg 1 hours before induction of anesthesia
ramosetron
ACTIVE COMPARATORramosetron 0.3 mg iv at end of surgery
Gabapentin and ramosetron
ACTIVE COMPARATORoral gabapentin 300 mg 1 hours before induction of anesthesia ramosetron 0.3 mg iv at end of surgery
Interventions
oral gabapentin 300 mg 1 hour before induction of anesthesia
oral gabapentin 300 mg 1 hour before induction of anesthesia and ramosetron 0.3 mg iv at end of surgery
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hallym University Sacred Heart Hospital
Anyang-si, Gyeonggi-do, KS009, South Korea
Related Publications (1)
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.
PMID: 28525981DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 18, 2015
First Posted
November 30, 2015
Study Start
November 1, 2015
Primary Completion
August 1, 2016
Study Completion
October 1, 2016
Last Updated
November 30, 2015
Record last verified: 2015-11