Trial Outcomes & Findings for Efficacy and Safety of Single, Low-dose Dexamethasone in Patients After Total Knee Arthroplasty (NCT NCT01612702)

Results Overview

A clinical investigator who is blinded to randomization assessed the incidence of postoperative nausea which defined as subjective unpleasant sensation associated with awareness of the urge to vomit and as emetic episode and vomiting

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

291 participants

Primary outcome timeframe

within 72 hours after surgery

Results posted on

2013-05-27

Participant Flow

305 patients who were scheduled for unilateral total knee arthroplasty at Seoul National Bundang Hospital from April 2011 to December 2011 were recruited.

14 patients were excluded before assignment. 5 were other diagnosis such as rheumatoid arthritis, secondary osteoarthritis, 4 had serious medical conditions such as renal failure, heary failure, 5 refused to participate

Participant milestones

Participant milestones
Measure	Dexamethasone dexamethasone 10 mg administration 1 hour before surgery	Control No dexamethasone
Overall Study STARTED	146	145
Overall Study COMPLETED	135	134
Overall Study NOT COMPLETED	11	11

Reasons for withdrawal

Reasons for withdrawal
Measure	Dexamethasone dexamethasone 10 mg administration 1 hour before surgery	Control No dexamethasone
Overall Study Protocol Violation	11	11

Baseline Characteristics

Efficacy and Safety of Single, Low-dose Dexamethasone in Patients After Total Knee Arthroplasty

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dexamethasone n=146 Participants dexamethasone 10 mg administration 1 hour before surgery	Control n=145 Participants No dexamethasone	Total n=291 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	14 Participants n=5 Participants	14 Participants n=7 Participants	28 Participants n=5 Participants
Age, Categorical >=65 years	132 Participants n=5 Participants	131 Participants n=7 Participants	263 Participants n=5 Participants
Age Continuous	72 years STANDARD_DEVIATION 6.7 • n=5 Participants	72 years STANDARD_DEVIATION 6.2 • n=7 Participants	72 years STANDARD_DEVIATION 6.4 • n=5 Participants
Sex: Female, Male Female	117 Participants n=5 Participants	119 Participants n=7 Participants	236 Participants n=5 Participants
Sex: Female, Male Male	29 Participants n=5 Participants	26 Participants n=7 Participants	55 Participants n=5 Participants
Region of Enrollment Korea, Republic of	146 participants n=5 Participants	145 participants n=7 Participants	291 participants n=5 Participants

PRIMARY outcome

Timeframe: within 72 hours after surgery

A clinical investigator who is blinded to randomization assessed the incidence of postoperative nausea which defined as subjective unpleasant sensation associated with awareness of the urge to vomit and as emetic episode and vomiting

Outcome measures

Outcome measures
Measure	Dexamethasone n=146 Participants dexamethasone 10 mg administration 1 hour before surgery	Control n=145 Participants No dexamethasone
Incidence of Nausea and Vomiting	24 percentage of participant Interval 22.8 to 25.2	40 percentage of participant Interval 38.0 to 42.0

SECONDARY outcome

Timeframe: 6 to 24 hours after surgery

A blinded investigator asked participants to recall the most severe pain level during 6 to 24 hour after surgery using with a visual analogue scale that ranged from 0 (no pain) to 10 (worst imaginable pain).

Outcome measures

Outcome measures
Measure	Dexamethasone n=146 Participants dexamethasone 10 mg administration 1 hour before surgery	Control n=145 Participants No dexamethasone
Pain Level	2.4 units on a scale Standard Deviation 1.0	4.0 units on a scale Standard Deviation 2.0

SECONDARY outcome

Timeframe: within 30 days after surgery

Number of participants with a sinus tract communicating with the prosthesis; a pathogen was isolated by culture from tissue or fluid samples taken from the affected joint; tests revealed elevated serum erythrocyte sedimentation rate (ESR) or serum C-reactive protein (CRP) concentration with elevated synovial white blood cell (WBC) count or neutrophil percentage; or pus discharge from the affected joint was present within 30 days after total knee arthroplasty were measured.

Outcome measures

Outcome measures
Measure	Dexamethasone n=146 Participants dexamethasone 10 mg administration 1 hour before surgery	Control n=145 Participants No dexamethasone
Wound Complication	1 participant	1 participant

Adverse Events

Dexamethasone

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Dexamethasone n=146 participants at risk dexamethasone 10 mg administration 1 hour before surgery	Control n=145 participants at risk No dexamethasone
Surgical and medical procedures Wound complication	0.68% 1/146 • Number of events 1 • 30 days after total knee arthroplasty wound complication such as postoperative infection, wound dehescence.	0.69% 1/145 • Number of events 1 • 30 days after total knee arthroplasty wound complication such as postoperative infection, wound dehescence.

Other adverse events

Adverse event data not reported

Additional Information

Dr. TK Kim

Joint Reconstruction Center, Seoul National University Bundang Hospital

Phone: 82-31-787-7196

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place