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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Tae Kyun Kim, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01612702
First received: June 3, 2012
Last updated: May 21, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention Phase
Osteoarthritis, Knee
Drug: Dexamethasone
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Use of a Single, Low-dose Dexamethasone in Total Knee Arthroplasty

Resource links provided by NLM:


Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • Incidence of Nausea and Vomiting [ Time Frame: within 72 hours after surgery ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Pain Level [ Time Frame: 6 to 24 hours after surgery ] [ Designated as safety issue: No ]
    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).

  • Wound Complication [ Time Frame: within 30 days after surgery ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 291
Study Start Date: April 2011
Study Completion Date: January 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dexamethasone
dexamethasone 10 mg administration 1 hour before surgery
Drug: Dexamethasone
Dexamethasone 10 mg intravenous administration
No Intervention: Control
No dexamethasone

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01612702

Locations
Korea, Republic of
Joint Reconstruction Center, Seoul National University Bundang Hospital
Seongnam-Si, Gyeonggi-do, Korea, Republic of, 463-707
Sponsors and Collaborators
Tae Kyun Kim
Investigators
Principal Investigator: T K Kim, MD, PhD Joint Recontruction Center, Seoul National University Bundang hospital
  More Information

No publications provided

Responsible Party: Tae Kyun Kim, Direcor, Joint reconstruction center, SNUBH, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01612702     History of Changes
Other Study ID Numbers: B-1102/121-006
Study First Received: June 3, 2012
Results First Received: June 6, 2012
Last Updated: May 21, 2013
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by Seoul National University Hospital:
postoperative nausea and vomiting
postoperative pain

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 30, 2014