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

Postoperative Nausea and Vomiting Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02830906
• Other study ID #: MTC-EC-OT-2-169/56
• Status: Completed
• Phase: Phase 3
• First received: July 6, 2016
• Last updated: July 9, 2016
• Start date: April 2014
• Est. completion date: March 2015

Study information

• Verified date: July 2016
• Source: Thammasat University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Interventional

Clinical Trial 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 .

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: March 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Nausea
• Postoperative Nausea and Vomiting
• Vomiting

Intervention

Drug:
• ramosetron
intravenous ramosetron 0.3 mg before spinal anesthesia and intrathecal morphine
• Ondansetron
intravenous ondansetron 8 mg before spinal anesthesia and intrathecal morphine

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Thammasat University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence rate of postoperative nausea and vomiting		48 hours after the operation	No
Secondary	number of patients require for anti-emetic medicine		48 hours after the operation	No
Secondary	visual analog scale for pain		48 hours after operation	No