- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01524731
The Effect of Prophylactic Antiemetic Dexamethasone on Plasma Cortisol Levels
The Effect of Prophylactic Antiemetic Dexamethasone on Plasma Cortisol Levels After Gynecologic Laparotomy
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Hypothesis:
The investigators hypothesize that preoperative administration of intravenous dexamethasone in non-cancer gynecologic laparotomy will decrease postoperative cortisol levels in a dose-dependent fashion.
Objectives:
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.
Methods:
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
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Quebec
-
Montreal, Quebec, Canada, H3A 1A1
- Royal Victoria Hospital
-
Montreal, Quebec, Canada, H3A 1A1
- McGill University Health Centre-Royal Victoria Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
Placebo group
|
Normal Saline
Other Names:
|
Active Comparator: 4 mg dexamethasone
4 mg dexamethasone group
|
4 mg
Other Names:
8 mg
Other Names:
|
Active Comparator: Dexamethasone 8 mg
Dexamethasone 8 mg group
|
4 mg
Other Names:
8 mg
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Post operative cortisol level
Time Frame: 24h post-operation
|
The primary outcome is the plasma cortisol level at 24h post-operation.
|
24h post-operation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
plasma cortisol
Time Frame: 72 hours post-operatively
|
Plasma cortisol levels at 6, 48 and 72 hours
|
72 hours post-operatively
|
Post operative nausea and vomiting scale
Time Frame: 72 hours post-operatively
|
Post operative nausea and vomiting at 6, 24, 48 and 72 hours
|
72 hours post-operatively
|
Post operative pain score
Time Frame: 72 hours post operatively
|
postoperative pain scores at 6, 24, 48 and 72 hours
|
72 hours post operatively
|
Blood glucose level
Time Frame: 72 hours post-operatively
|
blood glucose levels at 6, 24, 48 and 72 hours
|
72 hours post-operatively
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: William K. Li Pi Shan, MD, McGill University
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Postoperative Complications
- Signs and Symptoms, Digestive
- Nausea
- Vomiting
- Postoperative Nausea and Vomiting
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Anti-Inflammatory Agents
- Antineoplastic Agents
- Antiemetics
- Gastrointestinal Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Protease Inhibitors
- Dexamethasone
- Dexamethasone acetate
- BB 1101
Other Study ID Numbers
- 11-149-SDR
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Postoperative Nausea and Vomiting
-
Methodist Health SystemRecruitingNausea, Postoperative | Vomiting, PostoperativeUnited States
-
Cukurova UniversityTarsus UniversityRecruitingNausea, Postoperative | Vomiting, Postoperative | APFEL RİSK SCORETurkey
-
GlaxoSmithKlineCompletedPostoperative Nausea and Vomiting | Nausea and Vomiting, PostoperativeUnited States, Spain, Philippines, Israel, Hong Kong, Thailand, United Kingdom, Hungary, Slovenia, Norway, Denmark
-
MonoSol RxCompletedNausea With Vomiting Chemotherapy-Induced | Nausea and Vomiting, PostoperativeIndia
-
Yeungnam University College of MedicineCompletedPostoperative Nausea | Postoperative VomitingKorea, Republic of
-
Northwell HealthTerminatedPostoperative Pain | Postoperative Nausea | Postoperative VomitingUnited States
-
Hôpital Privé de Parly II - Le ChesnayCompletedPostoperative Nausea | Postoperative Vomiting | Postoperative EmesisFrance
-
Vestre VikenHF Kongsberg SykehusNorwegian Medical AssociationCompletedPostoperative Complications | Postoperative Pain | Postoperative Vomiting and Nausea | Mental Status Changes PostoperativeKazakhstan, Russian Federation
-
GlaxoSmithKlineCompletedPostoperative Nausea and Vomiting | Nausea and Vomiting, PostoperativeUnited States, Hungary, Canada, Spain, Belgium, Germany
-
Oregon Health and Science UniversityCompletedPostoperative Vomiting and NauseaUnited States
Clinical Trials on Dexamethasone
-
Ottawa Hospital Research InstituteCompletedPain Syndrome | Early-stage Breast CancerCanada
-
Vanderbilt University Medical CenterTerminatedAsthma | CroupUnited States
-
Dr. Stephen ChoiThe Physicians' Services Incorporated FoundationCompletedShoulder Surgery | Nerve BlockCanada
-
Shanghai Jiao Tong University Affiliated Sixth...CompletedAnalgesia | Time | Brachial Plexus Block | Shoulder Surgery | Dexamethasone | Intravenous Drug UsageChina
-
Centre hospitalier de l'Université de Montréal...CompletedPrevention of Hypersensitivity Reactions to PaclitaxelCanada
-
Universidade Federal de PernambucoCompletedDiabetic Macular EdemaBrazil
-
Universitätsklinikum Hamburg-EppendorfGemeinsamer Bundesausschuss (G-BA); Staburo GmbHRecruiting
-
University of BelgradeCompleted
-
Poznan University of Medical SciencesRecruitingWrist Injuries | Hand Injuries | Hand Injuries and Disorders | Hand Disease | Wrist DiseasePoland
-
University of California, San FranciscoCompletedOral Lichen Planus | Pemphigus Vulgaris | Mucous Membrane Pemphigoid | Chronic Graft-versus-host-diseaseUnited States