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

Phase 3

Completed

• Conditions: Postoperative Nausea and Vomiting
• Interventions: Drug: ramosetron; Drug: Ondansetron

• Registration Number: NCT02830906
• Lead Sponsor: 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 .

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 Timeline

• Study Start: 2014-04
• Primary Completion: 2015-02
• Study Completion: 2015-03
• Status Verified: 2016-07
• Study First Submitted: 2016-07-06
• Study First Submitted QC: 2016-07-09
• Last Update Submitted: 2016-07-09
• Study First Posted: 2016-07-13
• Last Update Posted: 2016-07-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 99

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ramosetron group	ramosetron	Patients received 0.3 mg of intravenous ramosetron before spinal anesthesia and intrathecal morphine
ondansetron group	Ondansetron	Patients received 8 mg of intravenous ondansetron before spinal anesthesia and intrathecal morphine

Primary Outcome Measures

Name	Time	Method
Incidence rate of postoperative nausea and vomiting	48 hours after the operation

Secondary Outcome Measures

Name	Time	Method
visual analog scale for pain	48 hours after operation
number of patients require for anti-emetic medicine	48 hours after the operation