- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01045876
The Effect of Dexamethasone on Cortisol Levels in Patients Undergoing Thyroid Surgery
The Effect of Dexamethasone on Plasma Cortisol Levels, Pain and PONV in Female Patients Undergoing Thyroid Surgery
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Purpose To examine the effect of dexamethasone, on plasma cortisol levels, postoperative pain, nausea and vomiting in patients undergoing thyroid surgery.
Hypothesis That dexamethasone administered at induction of anesthesia will result in reduced plasma cortisol levels, postoperative pain, nausea and vomiting.
Justification Dexamethasone is a synthetic steroid medication used routinely to prevent nausea and vomiting in patients undergoing general anesthetic. Administration of exogenous steroids can suppress production of endogenous steroids including cortisol.
Currently, no data exists describing the degree of suppression of cortisol production by a single preoperative dose of dexamethasone. This information would guide physicians prescribing dexamethasone in the perioperative period.
Objectives To compare plasma cortisol levels in patients receiving dexamethasone versus placebo at induction of anesthesia. To investigate the effect of dexamethasone on postoperative pain, nausea and vomiting.
Research Methods A prospective, randomized, controlled, double-blinded study conducted at a single center. Thirty patients will be recruited and randomly assigned to dexamethasone or placebo groups, in accordance with sample size calculations. A placebo group is necessary to eliminate the effects of potential confounding factors.
Statistical Analysis An interim analysis will be conducted to confirm the sample size calculation. Plasma cortisol level will be analyzed using 2-way analysis of variance (ANOVA). Secondary outcome measures will be analyzed with appropriate parametric or nonparametric methods.
Study Type
Phase
- Phase 4
Contacts and Locations
Study Locations
-
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British Columbia
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Vancouver, British Columbia, Canada, V6Z 1Y6
- St Paul's Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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:
- A diagnosis of anxiety, depression or bipolar disorder
- Disorders of the central nervous system, pituitary gland or hypothalamic-pituitary-adrenal axis
- Diabetes mellitus
- Pathological conditions affecting cortisol metabolism, including liver disease
- Chronic renal failure
- Alcoholism
- Obesity
- Anorexia nervosa/ starvation
- 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:
- Patients taking exogenous steroid medication which would suppress normal cortisol production.
- 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
Study Plan
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
|
2 ml of 0.9% Saline Solution administered intravenously at induction of anesthesia
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Experimental: Dexamethasone
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One dose of 8 mg of Dexamethasone intravenously at induction of anesthesia
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Plasma Cortisol level.
Time Frame: One, eight and twenty-four hours following Dexamethasone administration.
|
One, eight and twenty-four hours following Dexamethasone administration.
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Incidence of postoperative nausea and vomiting.
Time Frame: Twenty-four hours following surgery.
|
Twenty-four hours following surgery.
|
Pain intensity measured on the visual analogue scale.
Time Frame: Twenty-four hours following surgery
|
Twenty-four hours following surgery
|
Plasma Estradiol level.
Time Frame: One, eight and twenty-four hours following dexamethasone administration.
|
One, eight and twenty-four hours following dexamethasone administration.
|
Plasma Progesterone level.
Time Frame: One, eight and twenty-four hours following dexamethasone administration
|
One, eight and twenty-four hours following dexamethasone administration
|
Plasma ACTH level
Time Frame: One, eight and twenty-four hours following dexamethasone administration.
|
One, eight and twenty-four hours following dexamethasone administration.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jill A Osborn, MD, St Paul's Hospital, Vancouver and University of British Columbia
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Endocrine System Diseases
- Adrenal Gland Diseases
- Adrenal Insufficiency
- Physiological Effects of Drugs
- Autonomic Agents
- Peripheral Nervous System Agents
- Anti-Inflammatory Agents
- Antineoplastic Agents
- Antiemetics
- Gastrointestinal Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Dexamethasone
Other Study ID Numbers
- SPH-1515-DA
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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