NCT01045876

Brief 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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started May 2010

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 8, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 11, 2010

Completed
4 months until next milestone

Study Start

First participant enrolled

May 1, 2010

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

April 19, 2016

Status Verified

April 1, 2016

Enrollment Period

3.8 years

First QC Date

January 8, 2010

Last Update Submit

April 18, 2016

Conditions

Adrenal Insufficiency

Keywords

Randomized controlled trialDexamethasoneSingle dosePreoperativePlasma Cortisol level

Outcome Measures

Primary Outcomes (1)

  • Plasma Cortisol level.

    One, eight and twenty-four hours following Dexamethasone administration.

Secondary Outcomes (5)

  • Incidence of postoperative nausea and vomiting.

    Twenty-four hours following surgery.

  • Pain intensity measured on the visual analogue scale.

    Twenty-four hours following surgery

  • Plasma Estradiol level.

    One, eight and twenty-four hours following dexamethasone administration.

  • Plasma Progesterone level.

    One, eight and twenty-four hours following dexamethasone administration

  • Plasma ACTH level

    One, eight and twenty-four hours following dexamethasone administration.

Study Arms (2)

Dexamethasone

EXPERIMENTAL
Drug: Dexamethasone

Placebo

PLACEBO COMPARATOR
Other: Placebo

Interventions

DexamethasoneDRUG

One dose of 8 mg of Dexamethasone intravenously at induction of anesthesia

Dexamethasone
PlaceboOTHER

2 ml of 0.9% Saline Solution administered intravenously at induction of anesthesia

Placebo

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St Paul's Hospital

Vancouver, British Columbia, V6Z 1Y6, Canada

Location

MeSH Terms

Conditions

Adrenal Insufficiency

Interventions

Dexamethasone

Condition Hierarchy (Ancestors)

Adrenal Gland DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Study Officials

  • Jill A Osborn, MD

    St Paul's Hospital, Vancouver and University of British Columbia

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Anesthesiologist

Study Record Dates

First Submitted

January 8, 2010

First Posted

January 11, 2010

Study Start

May 1, 2010

Primary Completion

February 1, 2014

Study Completion

February 1, 2016

Last Updated

April 19, 2016

Record last verified: 2016-04

Locations

CA(1)