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

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ClinicalTrials.gov Identifier: NCT02617121
Recruitment Status : Unknown
Verified November 2015 by Hallym University Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : November 30, 2015
Last Update Posted : November 30, 2015
Sponsor:
Information provided by (Responsible Party):
Hallym University Medical Center

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

Condition or disease Intervention/treatment Phase
Postoperative Nausea and Vomiting Drug: Gabapentin Drug: Ramosetron Drug: Gabapentin and Ramosetron Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Comparison of the Prophylactic Anti-emetic Efficacy of Gabapentin and Ramosetron in Patients Undergoing Laparoscopic Gynecological Surgery
Study Start Date : November 2015
Estimated Primary Completion Date : August 2016
Estimated Study Completion Date : October 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Gabapentin
oral gabapentin 300 mg 1 hours before induction of anesthesia
Drug: Gabapentin
oral gabapentin 300 mg 1 hour before induction of anesthesia
Other Name: Neurontin

Active Comparator: ramosetron
ramosetron 0.3 mg iv at end of surgery
Drug: Ramosetron
ramosetron 0.3 mg iv at end of surgery
Other Name: Nasea

Active Comparator: Gabapentin and ramosetron
oral gabapentin 300 mg 1 hours before induction of anesthesia ramosetron 0.3 mg iv at end of surgery
Drug: Gabapentin and Ramosetron
oral gabapentin 300 mg 1 hour before induction of anesthesia and ramosetron 0.3 mg iv at end of surgery
Other Name: Neurontin and Nasea




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. side effects [ Time Frame: 48 hours postoperative ]
    The side effects such as somnolence, dizziness, headache, tremor, diplopia and nystagmus will be assessed and treated



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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02617121


Contacts
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Contact: Kyung Mi Kim, M.D. +82-31-380-3945 sumsonyo@hallym.or.kr
Contact: Soo Kyung Lee, Ph.D. +82-31-380-3945 agneta@hallym.or.kr

Locations
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Korea, Republic of
Hallym University Sacred Heart Hospital
Anyang-si, Gyeonggi-do, Korea, Republic of, KS009
Sponsors and Collaborators
Hallym University Medical Center

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Hallym University Medical Center
ClinicalTrials.gov Identifier: NCT02617121     History of Changes
Other Study ID Numbers: HallymUMC
First Posted: November 30, 2015    Key Record Dates
Last Update Posted: November 30, 2015
Last Verified: November 2015

Additional relevant MeSH terms:
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Nausea
Vomiting
Postoperative Nausea and Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Postoperative Complications
Pathologic Processes
Anesthetics
Gabapentin
Ramosetron
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anticonvulsants
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antimanic Agents
Antiemetics
Autonomic Agents
Gastrointestinal Agents
Serotonin Antagonists
Serotonin Agents