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

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02830906
Enrollment
99
Registered
2016-07-13
Start date
2014-04-30
Completion date
2015-03-31
Last updated
2016-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Nausea and Vomiting

Keywords

Total Knee Arthroplasty, Intrathecal Morphine, Ramosetron, Ondansetron, postoperative nausea and vomiting

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.

Interventions

DRUGramosetron

intravenous ramosetron 0.3 mg before spinal anesthesia and intrathecal morphine

DRUGOndansetron

intravenous ondansetron 8 mg before spinal anesthesia and intrathecal morphine

Sponsors

Thammasat University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Incidence rate of postoperative nausea and vomiting48 hours after the operation

Secondary

MeasureTime frame
number of patients require for anti-emetic medicine48 hours after the operation
visual analog scale for pain48 hours after operation

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026