Status:
UNKNOWN
Preoperative Oral Dexamethasone to Improve Recovery After Surgery
Lead Sponsor:
University of Manitoba
Conditions:
Breast Cancer
Eligibility:
FEMALE
18-80 years
Phase:
PHASE2
Brief Summary
Randomized controlled trial of pre-operative oral dexamethasone vs placebo for the improvement of quality of recovery from surgery. The study population is limited to breast surgery patients. The inve...
Detailed Description
Design: This will be a single centre randomized, double blind, parallel-group, intention to treat, controlled trial. Patients are randomly assigned to pre-operative oral dexamethasone or placebo Grou...
Eligibility Criteria
Inclusion
- Adults (18 to 80 years of age) undergoing general anesthesia for elective breast surgery (lumpectomy or mastectomy) and providing informed consent.
- American Society of Anesthesia (ASA) class I, II, \& III patients
Exclusion
- ASA class IV and V patients
- Pregnancy
- Diabetes
- History of allergy to any study medications
- Use of steroids or anti emetics within 1 month of surgery
- Chronic pain requiring opioid treatment
- History of alcohol or drug abuse (including smoking tobacco)
- Severe renal impairment (i.e. serum creatinine more than 160 umol/L)
- Poor English comprehension or psychiatric/central nervous system disturbance that would preclude completion of the QoR-40 questionnaire
Key Trial Info
Start Date :
August 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2015
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT02234466
Start Date
August 1 2014
End Date
June 1 2015
Last Update
September 9 2014
Active Locations (1)
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1
Health Science Centre
Winnipeg, Manitoba, Canada, R3A 1R9