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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2012 by St. Paul's Hospital, Canada
Sponsor:
Information provided by (Responsible Party):
Jill Osborn, St. Paul's Hospital, Canada
ClinicalTrials.gov Identifier:
NCT01045876
First received: January 8, 2010
Last updated: June 5, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention Phase
Adrenal Insufficiency
Drug: Dexamethasone
Other: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Official Title: The Effect of Dexamethasone on Plasma Cortisol Levels, Pain and PONV in Female Patients Undergoing Thyroid Surgery

Resource links provided by NLM:


Further study details as provided by St. Paul's Hospital, Canada:

Primary Outcome Measures:
  • Plasma Cortisol level. [ Time Frame: One, eight and twenty-four hours following Dexamethasone administration. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence of postoperative nausea and vomiting. [ Time Frame: Twenty-four hours following surgery. ] [ Designated as safety issue: No ]
  • Pain intensity measured on the visual analogue scale. [ Time Frame: Twenty-four hours following surgery ] [ Designated as safety issue: No ]
  • Plasma Estradiol level. [ Time Frame: One, eight and twenty-four hours following dexamethasone administration. ] [ Designated as safety issue: No ]
  • Plasma Progesterone level. [ Time Frame: One, eight and twenty-four hours following dexamethasone administration ] [ Designated as safety issue: No ]
  • Plasma ACTH level [ Time Frame: One, eight and twenty-four hours following dexamethasone administration. ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: May 2010
Estimated Study Completion Date: February 2016
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dexamethasone Drug: Dexamethasone
One dose of 8 mg of Dexamethasone intravenously at induction of anesthesia
Placebo Comparator: Placebo Other: Placebo
2 ml of 0.9% Saline Solution administered intravenously at induction of anesthesia

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01045876

Contacts
Contact: Jill Osborn, MD 01-604-806-8337 jillosborn@novuscom.net
Contact: Eleanor C Cleary, MB 353-86-984-5528 clearychristine@gmail.com

Locations
Canada, British Columbia
St Paul's Hospital Recruiting
Vancouver, British Columbia, Canada, V6Z 1Y6
Sponsors and Collaborators
St. Paul's Hospital, Canada
Investigators
Principal Investigator: Jill A Osborn, MD St Paul's Hospital, Vancouver and University of British Columbia
  More Information

No publications provided

Responsible Party: Jill Osborn, Anesthesiologist, St. Paul's Hospital, Canada
ClinicalTrials.gov Identifier: NCT01045876     History of Changes
Other Study ID Numbers: SPH-1515-DA
Study First Received: January 8, 2010
Last Updated: June 5, 2012
Health Authority: Canada: Health Canada

Keywords provided by St. Paul's Hospital, Canada:
Randomized controlled trial
Dexamethasone
Single dose
Preoperative
Plasma Cortisol level

Additional relevant MeSH terms:
Adrenal Insufficiency
Adrenal Gland Diseases
Endocrine System Diseases
BB 1101
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Anti-Inflammatory Agents
Antiemetics
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Autonomic Agents
Central Nervous System Agents
Enzyme Inhibitors
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protease Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014