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Gabapentin to Reduce Postoperative Nausea and Vomiting

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ClinicalTrials.gov Identifier: NCT02944981
Recruitment Status : Completed
First Posted : October 26, 2016
Last Update Posted : May 11, 2017
Sponsor:
Information provided by (Responsible Party):
Thepakorn Sathitkarnmanee, Khon Kaen University

Brief Summary:
The intrathecal administration of morphine is gaining popularity. It is easy to do and can reduce the pain after surgery up to 24 hours. However, it causes postoperative nausea and vomiting more than other methods providing postoperative analgesia. Patients suffering from these side effects have to spend a longer period of time recovering in the hospital with high cost of medical treatment.

Condition or disease Intervention/treatment Phase
Postoperative Nausea and Vomiting Drug: Gabapentin Drug: Placebo Phase 4

Detailed Description:

Objective: to study the efficacy of oral administrating of gabapentin 600 mg before surgery to reduce the postoperative nausea and vomiting in patients receiving intrathecal morphine.

Methods: Eighty patients undergoing orthopedic surgery and receiving intrathecal morphine will be randomized into 2 groups. The first group will receive oral gabapentin 600 mg and the second group will receive a placebo tablet. Both groups will receive a standard prophylactic medication for postoperative nausea and vomiting. The degrees of nausea and vomiting in both groups will be assessed over 24 hours postoperatively.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Gabapentin Premedication to Reduce Postoperative Nausea and Vomiting in Surgical Patient Receiving Spinal Morphine
Actual Study Start Date : August 2016
Actual Primary Completion Date : February 2017
Actual Study Completion Date : February 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Gabapentin
Patient receiving oral gabapentin 600 mg preoperatively
Drug: Gabapentin
Single oral dose
Other Name: Neurontin
Placebo Comparator: Placebo
Patient receiving oral placebo tablet preoperatively
Drug: Placebo
Single oral dose
Other Name: Sugar pill



Primary Outcome Measures :
  1. Postoperative nausea and vomiting (grade 1-3) [ Time Frame: through study completion, an average of 24 hours ]
    PONV grading: 0 = none; 1 = mild; 2 = moderate; 3 = severe



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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients undergoing general or regional anesthesia receiving spinal morphine
  • ASA physical status I-III

Exclusion Criteria:

  • Patients with allergy to morphine or gabapentin
  • Chronic use of narcotics
  • Psychotic
  • Bleeding disorder
  • Cardiovascular disorder
  • Liver or renal failure
  • Pregnancy or breast feeding
  • Neurologic disorder

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): NCT02944981


Locations
Thailand
Faculty of Medicine, Khon Kaen University
Khon Kaen, Thailand, 40002
Sponsors and Collaborators
Khon Kaen University
Investigators
Principal Investigator: Sirirat Tribuddharat, MD Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand

Publications of Results:
Responsible Party: Thepakorn Sathitkarnmanee, Associate Professor, Khon Kaen University
ClinicalTrials.gov Identifier: NCT02944981     History of Changes
Other Study ID Numbers: HE571129
First Posted: October 26, 2016    Key Record Dates
Last Update Posted: May 11, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Nausea
Vomiting
Postoperative Nausea and Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Postoperative Complications
Pathologic Processes
Gabapentin
gamma-Aminobutyric Acid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anticonvulsants
Antiparkinson Agents
Anti-Dyskinesia Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Antimanic Agents
GABA Agents