The Effect of Dexamethasone on Cortisol Levels in Patients Undergoing Thyroid Surgery

• Status: Withdrawn
• Trial end date: 2016-02-01
• Target enrollment: 0
• Participant gender: Female

Summary

Many drugs are used to prevent nausea and vomiting and pain after surgery. In this study the investigators will be looking at a drug, dexamethasone, which is commonly used to prevent nausea and vomiting and pain after surgery but has other side effects. Dexamethasone is a man-made drug that is commonly used during surgery but also can affect naturally occuring hormones. In this study the investigators will be looking at dexamethasone's effect on a number of naturally occuring hormones over a twenty four hour period after thyroid surgery. The investigators hypothesize that plasma cortisol levels will be decreased following administration of dexamethasone.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: St. Paul's Hospital, Canada
• Treatments: BB 1101; Cortisol succinate; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Hydrocortisone; Hydrocortisone 17-butyrate 21-propionate; Hydrocortisone acetate

Criteria

Inclusion Criteria:

• Female adult patients

• Undergoing thyroid surgery

• Euthyroid patients

• Qualify as Class I or II according to the American Society of Anesthesiologists physical status classification system

• Written informed consent

Exclusion Criteria:

• Patients who have medical conditions associated with abnormalities of the hypothalamic-pituitary-adrenal axis which might alter plasma cortisol levels will be excluded from the study. This category includes the following conditions:

1. A diagnosis of anxiety, depression or bipolar disorder

2. Disorders of the central nervous system, pituitary gland or hypothalamic-pituitary-adrenal axis

3. Diabetes mellitus

4. Pathological conditions affecting cortisol metabolism, including liver disease

5. Chronic renal failure

6. Alcoholism

7. Obesity

8. Anorexia nervosa/ starvation

9. High estrogen states, including pregnancy or use of OCP

• Patients taking medication which might alter the normal function of the hypothalamic-pituitary-adrenal axis. This category includes:

1. Patients taking exogenous steroid medication which would suppress normal cortisol production.

2. Patients taking medication which alters steroid metabolism, including barbiturates, phenytoin and rifampicin.

• Patients who have a known history of allergy, sensitivity or any other form of reaction to dexamethasone will be excluded from this study as they would be at risk of further reaction to dexamethasone.

• Patients who have previously been included in this study will be excluded from further recruitment.

• Patients who will undergo lateral neck dissection in association with the thyroid surgery will be excluded from the study as they will experience greater pain levels.

• Patients who participate in other clinical studies during this study or in the 14 days prior to admission to this study will be excluded