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

Tae Kyun Kim

Status and phase: Completed; Phase 4

Conditions: Osteoarthritis, Knee

Treatments: Drug: Dexamethasone

Study type: Interventional

Funder types: Other

Identifiers

NCT01612702

B-1102/121-006

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 291 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

291 participants in 2 patient groups

Dexamethasone

Experimental group

Description:

dexamethasone 10 mg administration 1 hour before surgery

Treatment:

Drug: Dexamethasone

Control

No Intervention group

Description:

No dexamethasone