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

July 9, 2016 updated by: piya pinsornsak, Thammasat University

Comparison of Ramosetron With Ondansetron for Prevention of Intrathecal Morphine Induced Nausea and Vomiting After Primary Total Knee Arthroplasty: A Randomized Control Trial

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 .

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

99

Phase

  • Phase 3

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

50 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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 Names:
  • 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence rate of postoperative nausea and vomiting
Time Frame: 48 hours after the operation
48 hours after the operation

Secondary Outcome Measures

Outcome Measure
Time Frame
number of patients require for anti-emetic medicine
Time Frame: 48 hours after the operation
48 hours after the operation
visual analog scale for pain
Time Frame: 48 hours after operation
48 hours after operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Thammasat University

Investigators

  • Principal Investigator: piya pinsornsak, md, Thammasat University

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

April 1, 2014

Primary Completion (Actual)

February 1, 2015

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

July 6, 2016

First Submitted That Met QC Criteria

July 9, 2016

First Posted (Estimate)

July 13, 2016

Study Record Updates

Last Update Posted (Estimate)

July 13, 2016

Last Update Submitted That Met QC Criteria

July 9, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MTC-EC-OT-2-169/56

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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