NCT01524731

Brief Summary

Dexamethasone is a synthetic corticosteroid that has been proven to be effective and relatively safe for the prophylaxis of the postoperative nausea and vomiting (PONV). However, little is known about its effect on the hypothalamic-pituitary-adrenal (HPA) axis after surgery. The investigators hypothesize that it will inhibit the normal physiologic HPA surge and reduce cortisol levels post-operatively ia a dose-dependant fashion. To answer this question, the investigators will conduct a randomized, double-blinded placebo-controlled trial with two different doses of dexamethasone in women undergoing elective gynecologic laparotomy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
63

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2012

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 24, 2012

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 2, 2012

Completed
3 months until next milestone

Study Start

First participant enrolled

May 1, 2012

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
Last Updated

September 4, 2014

Status Verified

September 1, 2014

Enrollment Period

1.6 years

First QC Date

January 24, 2012

Last Update Submit

September 2, 2014

Conditions

Postoperative Nausea and Vomiting

Outcome Measures

Primary Outcomes (1)

  • Post operative cortisol level

    The primary outcome is the plasma cortisol level at 24h post-operation.

    24h post-operation

Secondary Outcomes (4)

  • plasma cortisol

    72 hours post-operatively

  • Post operative nausea and vomiting scale

    72 hours post-operatively

  • Post operative pain score

    72 hours post operatively

  • Blood glucose level

    72 hours post-operatively

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Placebo group

Drug: Saline

4 mg dexamethasone

ACTIVE COMPARATOR

4 mg dexamethasone group

Drug: Dexamethasone

Dexamethasone 8 mg

ACTIVE COMPARATOR

Dexamethasone 8 mg group

Drug: Dexamethasone

Interventions

SalineDRUG

Normal Saline

Also known as: Normal Saline
Placebo
DexamethasoneDRUG

4 mg

Also known as: 4 mg dexamethasone
4 mg dexamethasone

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women between 18 and 80 years-old scheduled for non-oncologic gynecologic laparotomy, including fibroid myomectomy, hysterectomy and endometrioma resection

You may not qualify if:

  • Communication barrier rendering informed consent inadequate
  • Pregnancy
  • Diabetes mellitus
  • Chronic or acute renal failure
  • Chronic or acute hepatic failure
  • History of chronic opioid use
  • History of corticosteroid use more than 3 weeks in the last 6 months (inhaled, oral or intravenous)
  • History of disorders of the hypothalamus, pituitary gland and/or adrenal glands
  • History of depression and/or bipolar disorder
  • History of allergy or sensitivity to dexamethasone or any medication used in the standardised anesthetic care
  • American Society of Anesthesiologists Physical Status class of 3 and above.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

McGill University Health Centre-Royal Victoria Hospital

Montreal, Quebec, H3A 1A1, Canada

Location

Royal Victoria Hospital

Montreal, Quebec, H3A 1A1, Canada

Location

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Interventions

Sodium ChlorideSaline SolutionDexamethasone

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsNauseaSigns and Symptoms, DigestiveSigns and SymptomsVomiting

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium CompoundsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical PreparationsPregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Study Officials

  • William K. Li Pi Shan, MD

    McGill University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 24, 2012

First Posted

February 2, 2012

Study Start

May 1, 2012

Primary Completion

December 1, 2013

Study Completion

February 1, 2014

Last Updated

September 4, 2014

Record last verified: 2014-09

Locations

CA(2)