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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

291 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2012-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study was conducted to determine the efficacy of an additional preemptive, single, low-dose dexamethasone in terms of incidence and severity of postoperative nausea/vomiting (PONV), pain level, and the safety in terms of wound complications in patients managed with our antiemetic protocol based on Ramosetron following TKA.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

High vs Low Dose Dexamethasone on Complications in the Immediate Postoperative Phase

NCT03161938

Hip Dysplasia Postoperative Complications

COMPLETED PHASE4

Effect of Preoperative Intravenous Dexamethasone on Postoperative Pain After Primary Total Hip Arthroplasty

NCT03542617

Localized Primary Osteoarthritis of Both Hips (Diagnosis) Osteoarthritis, Hip

UNKNOWN PHASE4

Effect of Peri-operative Glucocorticoids on Short-term Functional Outcome After THA

NCT04317872

Coxarthrosis Avascular Necrosis of Hip

COMPLETED NA

Partial Synovectomy in Articular Side of Quadriceps Tendon Verified to Reduce Crepitus in Retrospective Study

NCT06129214

Osteoarthritis, Knee Rheumatoid Arthritis, Knee Spontaneous Osteonecrosis of Knee

RECRUITING NA

This is a Study to Verify if Periarticular Hip Injection of Corticosteroid After Hip Replacement Reduce the Pain and the Hospitalisation Time

NCT05023369

Femoral Neck Fractures

RECRUITING PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Postoperative pain and emesis can cause postoperative systemic complications and delay recovery and rehabilitation in patients following total knee arthroplasty (TKA). Furthermore, patients who suffered from severe postoperative pain and emesis tend to be dissatisfied with their surgical treatments. Although contemporary protocols to control perioperative pain and emesis after TKA have been reported to substantially reduce postoperative pain and emesis compared with traditional measures, pain and emesis after TKA remain to be a challenging issue for patients and health care providers. In our previous study, the use of Ramosetron was found to reduce postoperative emetic events, but the antiemetic effects by Ramosetron were incomplete. In search of a further antiemetic measure, we identified the use of dexamethasone as the additional measure fortifying our antiemetic protocol using Ramosetron.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Osteoarthritis, Knee

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Dexamethasone

dexamethasone 10 mg administration 1 hour before surgery

Group Type EXPERIMENTAL

Dexamethasone

Intervention Type DRUG

Dexamethasone 10 mg intravenous administration

Control

No dexamethasone

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Dexamethasone

Dexamethasone 10 mg intravenous administration

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No