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Analgesic Effect of Preoperative Dexamethasone in Gynecological Laparotomies - a Dose-ranging Study

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: NCT01022528
Recruitment Status : Completed
First Posted : December 1, 2009
Last Update Posted : October 17, 2013
Information provided by (Responsible Party):
Women's College Hospital

Brief Summary:

The objective of the study is to examine the effect of the addition of intravenous dexamethasone 1.5 hours prior to induction of anesthesia on the post-operative opioid consumption, pain scores, fatigue, and recovery in patients undergoing gynecological surgery with laparotomy under general anesthesia.

This is a dose finding study with two different doses (0.1 mg/kg vs. 0.2 mg/kg) of dexamethasone to find out the optimal efficacious dose of dexamethasone with minimal side effects.

Dexamethasone has anti-inflammatory, immunomodulatory, and analgesic effects; and is superior to placebo in providing post-operative pain control, lower analgesic consumption, prevention of postoperative nausea and vomiting, lesser post-operative fatigue, and better recovery profile. No dose response study has been done. The investigators hypothesize that a higher dose of dexamethasone may have an incremental beneficial effect.

Condition or disease Intervention/treatment Phase
Postoperative Pain Postoperative Nausea and Vomiting Fatigue Drug: Dexamethasone (0.1 mg/kg) Drug: Dexamethasone (0.2 mg/kg) Other: Saline Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 138 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Study Start Date : March 2009
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Dexamethasone Drug: Dexamethasone (0.1 mg/kg)
Other Name: Dose = 0.1 mg/kg

Drug: Dexamethasone (0.2 mg/kg)
Other Name: Dose = 0.2 mg/kg

Placebo Comparator: Saline Other: Saline

Primary Outcome Measures :
  1. Total cumulative morphine consumption via the patient-controlled analgesia (PCA) pump in the first 24 hours

Secondary Outcome Measures :
  1. Total cumulative postoperative morphine consumption after 48 hours
  2. Numerical Rating Scale at rest (supine) and on movement (on sitting) at baseline, 1, 6, 12, 24 and 48 hours after surgery
  3. Total fentanyl administration intraoperatively and in the PACU
  4. Time to first analgesic request in the PACU
  5. Time to discharge from the PACU

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients must be non-lactating
  • 18-65 years of age
  • ASA groups I-III for elective total abdominal hysterectomy (with or without salpingo-oophorectomy or minor bladder repair)or myomectomy through a lower transverse or low midline incision under general anesthesia. Incidental appendectomy and /or abdominal lipectomy were allowed as collateral surgical procedures if the same incision was used

Exclusion Criteria:

  • Emergent procedures
  • Diagnosed malignancy
  • History of allergy to dexamethasone
  • Allergy or contraindication to drugs used in study and anesthesia
  • Patients with uncontrolled diabetes mellitus, recent history of gastrointestinal bleeding or ulceration within 30 days before the study)
  • Patients who have taken drugs in the 12 hours preceding the surgery that could confound the analgesic response (specifically analgesics, neuroleptics, corticosteroids, NSAIDs)
  • Patients who have been on long term oral steroid therapy
  • Patients with BMI>40
  • Serious organ disease/ dysfunction
  • Chronic pain patients requiring >30mg morphine per day or equivalent
  • Severe psychiatric disease
  • Drug Addiction
  • Pregnancy
  • Language barrier
  • Inability to cooperate with the use of the intravenous PCA morphine pump

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): NCT01022528

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Canada, Ontario
Women's College Hospital
Toronto, Ontario, Canada, M5S 1B2
Sponsors and Collaborators
Women's College Hospital
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Responsible Party: Women's College Hospital Identifier: NCT01022528    
Other Study ID Numbers: 2009-0005-B
First Posted: December 1, 2009    Key Record Dates
Last Update Posted: October 17, 2013
Last Verified: October 2013
Keywords provided by Women's College Hospital:
Elective total abdominal hysterectomy (with or without salpingo-oophorectomy or minor bladder repair) or myomectomy
through a lower transverse or low midline incision under general anesthesia
Additional relevant MeSH terms:
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Postoperative Nausea and Vomiting
Signs and Symptoms
Postoperative Complications
Pathologic Processes
Signs and Symptoms, Digestive
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