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

NCT02830906 | Completed Phase 3 DMC

• 1 other identifier: MTC-EC-OT-2-169/56
• Study Type: interventional
• Target: 99
• Locations: 0 countries
• Sites: N/A

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 .

Conditions

Postoperative Nausea and Vomiting

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Incidence rate of postoperative nausea and vomiting

  48 hours after the operation

Secondary Outcomes (2)

• number of patients require for anti-emetic medicine

  48 hours after the operation

• visual analog scale for pain

  48 hours after operation

Study Arms (2)

ramosetron group

EXPERIMENTAL

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

Drug: ramosetron

ondansetron group

ACTIVE COMPARATOR

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

Drug: Ondansetron

Interventions

ramosetron DRUG

intravenous ramosetron 0.3 mg before spinal anesthesia and intrathecal morphine

Also known as: ramosetorn

ramosetron group

Ondansetron DRUG

intravenous ondansetron 8 mg before spinal anesthesia and intrathecal morphine

ondansetron group

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Thammasat University: lead

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Interventions

ramosetron; Ondansetron

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring

Study Officials

• piya pinsornsak, md

  Thammasat University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor

Study Record Dates

• First Submitted: July 6, 2016
• First Posted: July 13, 2016
• Study Start: April 1, 2014
• Primary Completion: February 1, 2015
• Study Completion: March 1, 2015
• Last Updated: July 13, 2016

Record last verified: 2016-07

Data Sharing

• IPD Sharing: Will not share