Additional Anti-emetic Effect of Ramosetron Prophylaxis After Total Knee Arthroplasty

NCT01102491 | Completed Phase 4 Results

• 1 other identifier: B-1001/091-003
• Study Type: interventional
• Target: 153
• Locations: 1 country
• Sites: 1

Brief Summary

The purposes of this study are to document the antiemetic efficacy of multimodal antiemetic protocol in patient after Total Knee Arthroplasty using regional anesthesia, midazolam \& propofol, hydration \& oxygen supplement, preemptive \& multimodal contemporary pain management and to determine whether Ramosetron prophylaxis would provide additional antiemetic effect on this protocol. We hypothesized that the incidence of Postoperative nausea and vomiting during multimodal antiemetic protocol would be lower than Apfel's expected postoperative nausea and vomiting incidence. It was also hypothesized that Ramosetron prophylaxis would provide additional antiemetic effect.

Conditions

Osteoarthritis, Knee

Keywords

postoperative nausea and vomiting

Outcome Measures

Primary Outcomes (1)

• Incidence of Nausea and Vomiting

  outcomes assessor who is blinded to randomization assessed the incidence of postoperative nausea which was defined as subjectively unpleasant sensation associated with awareness of the urge to vomit and an emetic episode and vomiting

  within 48 hours after surgery

Secondary Outcomes (1)

• Incidence of Rescue Antiemetic Administration

  within 48 hours after surgery

Study Arms (2)

Ramosetron prophylaxis

EXPERIMENTAL

ramosetron prophylaxis at the end of surgery with starting PCA and 1 day after surgery

Drug: Ramosetron

Control

NO INTERVENTION

no antiemetic prophylaxis

Interventions

Ramosetron DRUG

ramosetron intravenous injection, 0.3mg, 1 time/day for 2 days

Also known as: Nasea

Ramosetron prophylaxis

Eligibility Criteria

• Age: 18 Years - 86 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of primary osteoarthritis, knee
• Scheduled for elective total knee arthroplasty
• Signed written informed consent

You may not qualify if:

• Refusing participate
• Contraindication to regional anesthesia
• Severe impairment of bowel motility
• administration of other antiemetics within 24hours before surgery
• systemic steroid within 24hours before surgery
• history of cardiovascular \& respiratory disease
• renal \& hepatic failure

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Joint Reconstruction Center, Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 463-707, South Korea

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Postoperative Nausea and Vomiting

Interventions

ramosetron

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting

Results Point of Contact

• Title: TK Kim
• Organization: Joint Reconstruction Center, Seoul National University Bundang Hospital

osktk@snubh.org

82-31-787-7196

Study Officials

• T K Kim, MD,PhD

  Joint Recontruction Center, Seoul National University Bundang hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2010
• First Posted: April 13, 2010
• Study Start: September 1, 2009
• Primary Completion: February 1, 2010
• Study Completion: March 1, 2010
• Last Updated: June 8, 2012
• Results First Posted: May 21, 2010

Record last verified: 2012-06

Locations

KR (1)