Adrenal InsufficiencyPhase 4NCT01045876
The Effect of Dexamethasone on Cortisol Levels in Patients Undergoing Thyroid Surgery
A Phase 4 study testing Dexamethasone in people with Adrenal Insufficiency, run by St. Paul's Hospital, Canada at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Adrenal Insufficiency
- What is being tested?
- Dexamethasone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- May 2010to Feb 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Dexamethasone on Plasma Cortisol Levels, Pain and PONV in Female Patients Undergoing Thyroid Surgery
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.
Read the 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.
- Conditions
- Adrenal Insufficiency
- Being tested
- Dexamethasone, Placebo
- Keywords
- Randomized controlled trial, Dexamethasone, Single dose, Preoperative, Plasma Cortisol level
- Medical subject headings
- Adrenal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
One dose of 8 mg of Dexamethasone intravenously at induction of anesthesia
PlaceboOther
2 ml of 0.9% Saline Solution administered intravenously at induction of anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Dexamethasone | Experimental | Not described Receives: Drug: Dexamethasone |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma Cortisol level.
Measured: One, eight and twenty-four hours following Dexamethasone administration.
Secondary outcomes (5)
Incidence of postoperative nausea and vomiting.
Measured: Twenty-four hours following surgery.
Pain intensity measured on the visual analogue scale.
Measured: Twenty-four hours following surgery
Plasma Estradiol level.
Measured: One, eight and twenty-four hours following dexamethasone administration.
Plasma Progesterone level.
Measured: One, eight and twenty-four hours following dexamethasone administration
Plasma ACTH level
Measured: One, eight and twenty-four hours following dexamethasone administration.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2010 (estimated)
- Study startMay 2010
- Primary completionFeb 2014 (estimated)
- Study completionFeb 2016 (estimated)
Why it stopped: Lack of resources
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adrenal InsufficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Paul's Hospital, Canada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jill Osborn, St. Paul's Hospital, Canada
- Investigators
- Jill A Osborn, MD, Principal investigator, St Paul's Hospital, Vancouver and University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01045876
- Sponsor's protocol ID
- SPH-1515-DA
- Status last verified
- Apr 2016
- First submitted
- 8 Jan 2010
- Last updated
- 19 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Dexamethasone on Plasma Cortisol Levels, Pain and PONV in Female Patients Undergoing Thyroid Surgery
- ClinicalTrials.gov ID
- NCT01045876
- Acronym / sponsor ID
- SPH-1515-DA
- Conditions
- Adrenal Insufficiency
- Keywords
- Randomized controlled trial, Dexamethasone, Single dose, Preoperative, Plasma Cortisol level
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of resources
- Enrolment
- 0 participants (actual)
- Lead sponsor
- St. Paul's Hospital, CanadaUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Feb 2014 (estimated)
- Study completion
- Feb 2016 (estimated)
- First posted
- 11 Jan 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexamethasone | Experimental | Drug: Dexamethasone |
| Placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (17 listed)
- 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:
- Patients taking medication which might alter the normal function of the hypothalamic-pituitary-adrenal axis. This category includes:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DexamethasoneOne dose of 8 mg of Dexamethasone intravenously at induction of anesthesia | Drug | Dexamethasone |
| Placebo2 ml of 0.9% Saline Solution administered intravenously at induction of anesthesia | Other | Placebo |
Primary outcome
Plasma Cortisol level.
Time frame: One, eight and twenty-four hours following Dexamethasone administration.
5 secondary outcomes
Incidence of postoperative nausea and vomiting.
Time frame: Twenty-four hours following surgery.
Pain intensity measured on the visual analogue scale.
Time frame: Twenty-four hours following surgery
Plasma Estradiol level.
Time frame: One, eight and twenty-four hours following dexamethasone administration.
Plasma Progesterone level.
Time frame: One, eight and twenty-four hours following dexamethasone administration
Plasma ACTH level
Time frame: One, eight and twenty-four hours following dexamethasone administration.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jill A Osborn, MD principal investigator
St Paul's Hospital, Vancouver and University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexamethasone in people with Adrenal Insufficiency, run by St. Paul's Hospital, Canada at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 19 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma Cortisol level. (time frame: One, eight and twenty-four hours following Dexamethasone administration.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2016.