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Effect of Ramosetron in Prevention of Intrathecal Morphine Induced Nausea and Vomiting

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ClinicalTrials.gov Identifier: NCT02830906
Recruitment Status : Completed
First Posted : July 13, 2016
Last Update Posted : July 13, 2016
Sponsor:
Information provided by (Responsible Party):
piya pinsornsak, Thammasat University

Brief Summary:
We would like to know the prophylactic anti-emetic effect of ramosetron compare to ondansetron in patient undergone total knee arthroplasty with spinal anesthesia and intrathecal morphine .

Condition or disease Intervention/treatment Phase
Postoperative Nausea and Vomiting Drug: ramosetron Drug: Ondansetron Phase 3

Detailed Description:

The patients were allocated into 2 groups by computerized block randomization according to a computer generated randomization. Treatment allocations were contained in sealed envelopes that were opened after patient enrollment. Patients received either 8 mg of intravenous (IV) ondansetron or 0.3 mg of IV ramosetron 10 minutes before spinal anesthesia and intrathecal morphine. All of the unilateral TKAs were done by one orthopedic surgeon using the same minimally invasive surgical technique and the same prosthesis.

Patients were monitored for incidence of Post Operative Nausea Vomiting(PONV) every 6 hours until 24 hours, and 24-48 hours postoperatively. Common adverse drug reactions associated with serotonin receptor antagonists (pruritus, dizziness, and headache) were also recorded.

The sample size calculation was based on the ability to detect a difference in incidence of postoperative nausea in between the two groups of 40% i.e. 50% in the ondansetron arm, and 30% in the ramosetron arm, consistent with a previous study. Using a power of 80% (β=0.2) and a two sided significance level(alpha) of 0.05, 45 patients in each group were required.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 99 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Ramosetron With Ondansetron for Prevention of Intrathecal Morphine Induced Nausea and Vomiting After Primary Total Knee Arthroplasty: A Randomized Control Trial
Study Start Date : April 2014
Actual Primary Completion Date : February 2015
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: ramosetron group
Patients received 0.3 mg of intravenous ramosetron before spinal anesthesia and intrathecal morphine
Drug: ramosetron
intravenous ramosetron 0.3 mg before spinal anesthesia and intrathecal morphine
Other Name: ramosetorn

Active Comparator: ondansetron group
Patients received 8 mg of intravenous ondansetron before spinal anesthesia and intrathecal morphine
Drug: Ondansetron
intravenous ondansetron 8 mg before spinal anesthesia and intrathecal morphine




Primary Outcome Measures :
  1. Incidence rate of postoperative nausea and vomiting [ Time Frame: 48 hours after the operation ]

Secondary Outcome Measures :
  1. number of patients require for anti-emetic medicine [ Time Frame: 48 hours after the operation ]
  2. visual analog scale for pain [ Time Frame: 48 hours after operation ]


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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients aged 50-80 years with a diagnosis of primary OA undergoing unilateral TKA
  • American Society of Anesthesiologist (ASA) physical status I-III
  • Giving written informed consent

Exclusion Criteria:

  • Body mass index (BMI) > 35 kg/m2
  • Unable to undergo spinal anesthesia
  • History of allergic to study drugs
  • Impaired renal and/or hepatic function
  • Use of systemic steroids and anti-emetics within 24 hours of operation

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): NCT02830906


Sponsors and Collaborators
Thammasat University
Investigators
Principal Investigator: piya pinsornsak, md Thammasat University

Responsible Party: piya pinsornsak, associate professor, Thammasat University
ClinicalTrials.gov Identifier: NCT02830906     History of Changes
Other Study ID Numbers: MTC-EC-OT-2-169/56
First Posted: July 13, 2016    Key Record Dates
Last Update Posted: July 13, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by piya pinsornsak, Thammasat University:
Total Knee Arthroplasty
Intrathecal Morphine
Ramosetron
Ondansetron
postoperative nausea and vomiting

Additional relevant MeSH terms:
Nausea
Vomiting
Postoperative Nausea and Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Postoperative Complications
Pathologic Processes
Anesthetics
Morphine
Ondansetron
Ramosetron
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Opioid
Narcotics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Antiemetics
Autonomic Agents
Gastrointestinal Agents
Antipruritics
Dermatologic Agents
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antipsychotic Agents
Tranquilizing Agents
Psychotropic Drugs