The Effect of Prophylactic Antiemetic Dexamethasone on Plasma Cortisol Levels

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01524731
Recruitment Status : Completed
First Posted : February 2, 2012
Last Update Posted : September 4, 2014
Information provided by (Responsible Party):
William Li Pi Shan, McGill University Health Center

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.

Condition or disease Intervention/treatment Phase
Postoperative Nausea and Vomiting Drug: Saline Drug: Dexamethasone Not Applicable

Detailed Description:


The investigators hypothesize that preoperative administration of intravenous dexamethasone in non-cancer gynecologic laparotomy will decrease postoperative cortisol levels in a dose-dependent fashion.


To compare the post-operative plasma cortisol and glucose level in patients receiving various single doses of dexamethasone versus placebo at the start of gynecologic laparotomy.

To assess the dose-dependent effect of dexamethasone on postoperative pain, nausea and vomiting in this particular context.

To assess the dose-dependent effect of dexamethasone on length of hospital stay.


This will be a prospective, randomised, double-blinded trial with two intervention arms and a placebo-control arm conducted at the Royal Victoria Hospital of the McGill University Health Center, Montreal, Canada.

Patients eligible to participate in the study based on inclusion and exclusion criteria will be approached in the preoperative anesthesia clinic (at least one week before the scheduled operation) and some patients will be recruited on the day of surgery hours before in the waiting room by a study personnel who will not be involved in the patient care the day of the surgery. After addressing the patient's questions and concerns, informed consent will be obtained. The patient, the investigators and the anesthesiologist in charge of the patient will be blinded to group allocation until completion of the study.

After patient recruitment, an intravenous line will be placed inside the operating room. Blood will simultaneously be drawn for a baseline plasma cortisol levels. The patients will receive a single IV bolus dose of dexamethasone 4mg, 8mg or an IV normal saline placebo (based on group allocation by randomization) immediately after induction of anesthesia 8. Anesthetic premedication will comprise of 1mg of midazolam. Induction will be performed using 2-3 mg/kg propofol, 2-3 mcg/kg fentanyl, 0.5-1.0 mg/kg rocuronium. Anesthetic maintenance will be performed through an endotracheal tube using desflurane at a minimum of 1 MAC in an equal air/oxygen mixture. Endtidal carbon dioxide tension will be maintained at 40 mmHg using the appropriate ventilator adjustments. Fluid management consists of crystalloid boluses of 20 mg/kg to replace fasting losses, colloid and blood products as necessary according to the surgical losses. Neostigmine and glycopyrrolate reversal will be used if no train of four twitch exists. Ondansetron 4 mg will be given to all patients prior to tracheal extubation.

In the postoperative anesthesia care unit, dimenhydrinate 25-50 mg, prochlorperazine 10 mg will be used should nausea, vomiting, or retching occur. Pain will be controlled by rectal acetaminophen 325mg-1.3 g. Patient controlled analgesia fentanyl will be administered to all patients at a lockout interval of 7 minutes. In the gynaecological ward, dimenhydrinate will be used to control nausea and vomiting.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 63 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Prophylactic Antiemetic Dexamethasone on Plasma Cortisol Levels After Gynecologic Laparotomy
Study Start Date : May 2012
Actual Primary Completion Date : December 2013
Actual Study Completion Date : February 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Placebo Comparator: Placebo
Placebo group
Drug: Saline
Normal Saline
Other Name: Normal Saline

Active Comparator: 4 mg dexamethasone
4 mg dexamethasone group
Drug: Dexamethasone
4 mg
Other Name: 4 mg dexamethasone

Active Comparator: Dexamethasone 8 mg
Dexamethasone 8 mg group
Drug: Dexamethasone
8 mg
Other Name: 8 mg dexamethasone

Primary Outcome Measures :
  1. Post operative cortisol level [ Time Frame: 24h post-operation ]
    The primary outcome is the plasma cortisol level at 24h post-operation.

Secondary Outcome Measures :
  1. plasma cortisol [ Time Frame: 72 hours post-operatively ]
    Plasma cortisol levels at 6, 48 and 72 hours

  2. Post operative nausea and vomiting scale [ Time Frame: 72 hours post-operatively ]
    Post operative nausea and vomiting at 6, 24, 48 and 72 hours

  3. Post operative pain score [ Time Frame: 72 hours post operatively ]
    postoperative pain scores at 6, 24, 48 and 72 hours

  4. Blood glucose level [ Time Frame: 72 hours post-operatively ]
    blood glucose levels at 6, 24, 48 and 72 hours

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01524731

Canada, Quebec
McGill University Health Centre-Royal Victoria Hospital
Montreal, Quebec, Canada, H3A 1A1
Royal Victoria Hospital
Montreal, Quebec, Canada, H3A 1A1
Sponsors and Collaborators
William Li Pi Shan
Principal Investigator: William K. Li Pi Shan, MD McGill University

Responsible Party: William Li Pi Shan, Assistant Professor, McGill University Health Center Identifier: NCT01524731     History of Changes
Other Study ID Numbers: 11-149-SDR
First Posted: February 2, 2012    Key Record Dates
Last Update Posted: September 4, 2014
Last Verified: September 2014

Additional relevant MeSH terms:
Postoperative Nausea and Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Postoperative Complications
Pathologic Processes
Dexamethasone acetate
BB 1101
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action