- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02617121
The Effects of Gabapentin and Ramosetron on Postoperative Nausea and Vomiting in Laparoscopic Gynecological Surgery (PONV)
November 25, 2015 updated by: Hallym University Medical Center
Comparison of the Prophylactic Anti-emetic Efficacy of Gabapentin and Ramosetron in Patients Undergoing Laparoscopic Gynecological Surgery
This study was designed to compare the effects of gabapentin and ramosetron on PONV in patients undergoing laparoscopic gynecologic surgery.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
120
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Gyeonggi-do
-
Anyang-si, Gyeonggi-do, Korea, Republic of, KS009
- Hallym University Sacred Heart Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Gabapentin
oral gabapentin 300 mg 1 hours before induction of anesthesia
|
oral gabapentin 300 mg 1 hour before induction of anesthesia
Other Names:
|
Active Comparator: ramosetron
ramosetron 0.3 mg iv at end of surgery
|
ramosetron 0.3 mg iv at end of surgery
Other Names:
|
Active Comparator: Gabapentin and ramosetron
oral gabapentin 300 mg 1 hours before induction of anesthesia ramosetron 0.3 mg iv at end of surgery
|
oral gabapentin 300 mg 1 hour before induction of anesthesia and ramosetron 0.3 mg iv at end of surgery
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of postoperative nausea and vomiting
Time Frame: 48 hours postoperative
|
The incidence of postoperative nausea and vomiting will be assessed during 48 hours after surgery
|
48 hours postoperative
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Severity of nausea
Time Frame: 48 hours postoperative
|
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
|
pain score
Time Frame: 48 hours postoperative
|
The pain score will be assessed using verbal rating scales (VRS 11-points scales: 0=none to 10=most severe)
|
48 hours postoperative
|
sedation score
Time Frame: 48 hours postoperative
|
The sedation score will be assessed using verbal rating scales (VRS 11-points scales:0=none to 10=most severe)
|
48 hours postoperative
|
patient's overall satisfaction score
Time Frame: 48 hours postoperative
|
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
|
side effects
Time Frame: 48 hours postoperative
|
The side effects such as somnolence, dizziness, headache, tremor, diplopia and nystagmus will be assessed and treated
|
48 hours postoperative
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2015
Primary Completion (Anticipated)
August 1, 2016
Study Completion (Anticipated)
October 1, 2016
Study Registration Dates
First Submitted
November 18, 2015
First Submitted That Met QC Criteria
November 25, 2015
First Posted (Estimate)
November 30, 2015
Study Record Updates
Last Update Posted (Estimate)
November 30, 2015
Last Update Submitted That Met QC Criteria
November 25, 2015
Last Verified
November 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Postoperative Complications
- Signs and Symptoms, Digestive
- Nausea
- Vomiting
- Postoperative Nausea and Vomiting
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Autonomic Agents
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Excitatory Amino Acid Antagonists
- Excitatory Amino Acid Agents
- Antiemetics
- Gastrointestinal Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Serotonin Agents
- Serotonin Antagonists
- Anti-Anxiety Agents
- Anticonvulsants
- Antimanic Agents
- Gabapentin
- Ramosetron
Other Study ID Numbers
- HallymUMC
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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