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Trial Outcomes & Findings for Additional Anti-emetic Effect of Ramosetron Prophylaxis After Total Knee Arthroplasty (NCT NCT01102491)

NCT ID: NCT01102491

Last Updated: 2012-06-08

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

153 participants

Primary outcome timeframe

within 48 hours after surgery

Results posted on

2012-06-08

Participant Flow

153 patients whose diagnosis was primary osteoarthritis scheduled for unilateral total knee arthroplasty(TKA)at Seoul National University Bundang Hospital from October 2009 to March 2010 were recruited.

11 patients were excluded before assignment. 6 were other diagnosis such as rheumatoid arthritis, secondary osteoarthritis, 2 were refused to participate this study, and 3 were serious medical conditions such as respiratory failure, heart failure.

Participant milestones

Participant milestones
Measure
Ramosetron Prophylaxis
ramosetron prophylaxis at the end of surgery with starting PCA and 1 day after surgery
Control
no antiemetic prophylaxis
Overall Study
STARTED
71
71
Overall Study
COMPLETED
60
59
Overall Study
NOT COMPLETED
11
12

Reasons for withdrawal

Reasons for withdrawal
Measure
Ramosetron Prophylaxis
ramosetron prophylaxis at the end of surgery with starting PCA and 1 day after surgery
Control
no antiemetic prophylaxis
Overall Study
Protocol Violation
11
12

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Ramosetron Prophylaxis
n=71 Participants
ramosetron prophylaxis at the end of surgery with starting PCA and 1 day after surgery
Control
n=71 Participants
no antiemetic prophylaxis
Total
n=142 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
13 Participants
n=5 Participants
16 Participants
n=7 Participants
29 Participants
n=5 Participants
Age, Categorical
>=65 years
58 Participants
n=5 Participants
55 Participants
n=7 Participants
113 Participants
n=5 Participants
Age Continuous
69.1 years
STANDARD_DEVIATION 6.3 • n=5 Participants
69.0 years
STANDARD_DEVIATION 7.5 • n=7 Participants
69.1 years
STANDARD_DEVIATION 6.8 • n=5 Participants
Sex: Female, Male
Female
64 Participants
n=5 Participants
65 Participants
n=7 Participants
129 Participants
n=5 Participants
Sex: Female, Male
Male
7 Participants
n=5 Participants
6 Participants
n=7 Participants
13 Participants
n=5 Participants
Region of Enrollment
Korea, Republic of
71 participants
n=5 Participants
71 participants
n=7 Participants
142 participants
n=5 Participants

PRIMARY outcome

Timeframe: within 48 hours after surgery

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

Outcome measures

Outcome measures
Measure
Ramosetron Prophylaxis
n=71 Participants
ramosetron prophylaxis at the end of surgery with starting PCA and 1 day after surgery
Control
n=71 Participants
no antiemetic prophylaxis
Incidence of Nausea and Vomiting
25 participants
32 participants

SECONDARY outcome

Timeframe: within 48 hours after surgery

outcome assessor assessed the incidence of rescue antiemetic administration

Outcome measures

Outcome data not reported

Adverse Events

Ramosetron Prophylaxis

Serious events: 27 serious events
Other events: 4 other events
Deaths: 0 deaths

Control

Serious events: 25 serious events
Other events: 2 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
Ramosetron Prophylaxis
n=71 participants at risk
ramosetron prophylaxis at the end of surgery with starting PCA and 1 day after surgery
Control
n=71 participants at risk
no antiemetic prophylaxis
Nervous system disorders
Drowsiness
38.0%
27/71
35.2%
25/71

Other adverse events

Other adverse events
Measure
Ramosetron Prophylaxis
n=71 participants at risk
ramosetron prophylaxis at the end of surgery with starting PCA and 1 day after surgery
Control
n=71 participants at risk
no antiemetic prophylaxis
Nervous system disorders
headache
5.6%
4/71
2.8%
2/71

Additional Information

TK Kim

Joint Reconstruction Center, Seoul National University Bundang Hospital

Phone: 82-31-787-7196

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place