Preoperative Oral Dexamethasone to Improve Recovery After Surgery

• Status: Unknown status
• Trial end date: 2015-06-01
• Target enrollment: 0
• Participant gender: Female

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 investigators will also look at the effect of our intervention on post operative nausea and vomiting.

Patients will be recruited before the date of their surgery and will complete the Quality of Recovery-40 (QOR-40) questionnaire before their surgery and at 24 hours post op. They will also complete a Clinically significant nausea and vomiting score upon discharge from the post anesthesia recovery room, repeated at 24 hours post op.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Manitoba
• Treatments: BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Ondansetron

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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