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

NCT ID: NCT02830906

Last Updated: 2016-07-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 99 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-30
• Study Completion Date: 2015-03-31

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.

Conditions

Postoperative Nausea and Vomiting

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

ramosetron group

Patients received 0.3 mg of intravenous ramosetron before spinal anesthesia and intrathecal morphine

Group Type: EXPERIMENTAL

ramosetron

Intervention Type: DRUG

intravenous ramosetron 0.3 mg before spinal anesthesia and intrathecal morphine

ondansetron group

Patients received 8 mg of intravenous ondansetron before spinal anesthesia and intrathecal morphine

Group Type: ACTIVE_COMPARATOR

Ondansetron

Intervention Type: DRUG

intravenous ondansetron 8 mg before spinal anesthesia and intrathecal morphine

Interventions

ramosetron

intravenous ramosetron 0.3 mg before spinal anesthesia and intrathecal morphine

Intervention Type: DRUG

Ondansetron

intravenous ondansetron 8 mg before spinal anesthesia and intrathecal morphine

Intervention Type: DRUG

Other Intervention Names

ramosetorn

Eligibility 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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Thammasat University

OTHER

Sponsor Role: lead

Responsible Party

piya pinsornsak

associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

piya pinsornsak, md

Role: PRINCIPAL_INVESTIGATOR

Thammasat University

Other Identifiers

MTC-EC-OT-2-169/56

Identifier Type: -

Identifier Source: org_study_id