The Effect of Prophylactic Antiemetic Dexamethasone on Plasma Cortisol Levels

• Status: Completed
• Trial end date: 2014-02-01
• Target enrollment: 0
• Participant gender: Female

Summary

Dexamethasone is a synthetic corticosteroid that has been proven to be effective and relatively safe for the prophylaxis of the postoperative nausea and vomiting (PONV).

However, little is known about its effect on the hypothalamic-pituitary-adrenal (HPA) axis after surgery. The investigators hypothesize that it will inhibit the normal physiologic HPA surge and reduce cortisol levels post-operatively ia a dose-dependant fashion. To answer this question, the investigators will conduct a randomized, double-blinded placebo-controlled trial with two different doses of dexamethasone in women undergoing elective gynecologic laparotomy.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: William Li Pi Shan
• Treatments: Antiemetics; BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Hydrocortisone

Criteria

Inclusion Criteria:

• Women between 18 and 80 years-old scheduled for non-oncologic gynecologic laparotomy, including fibroid myomectomy, hysterectomy and endometrioma resection

Exclusion Criteria:

• Communication barrier rendering informed consent inadequate

• Pregnancy

• Diabetes mellitus

• Chronic or acute renal failure

• Chronic or acute hepatic failure

• History of chronic opioid use

• History of corticosteroid use more than 3 weeks in the last 6 months (inhaled, oral or intravenous)

• History of disorders of the hypothalamus, pituitary gland and/or adrenal glands

• History of depression and/or bipolar disorder

• History of allergy or sensitivity to dexamethasone or any medication used in the standardised anesthetic care

• American Society of Anesthesiologists Physical Status class of 3 and above.