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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Women's College Hospital
ClinicalTrials.gov Identifier:
NCT01022528
First received: November 27, 2009
Last updated: October 15, 2013
Last verified: October 2013
  Purpose

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 Intervention
Postoperative Pain
Postoperative Nausea and Vomiting
Fatigue
Drug: Dexamethasone (0.1 mg/kg)
Drug: Dexamethasone (0.2 mg/kg)
Other: Saline

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Women's College Hospital:

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

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

Enrollment: 138
Study Start Date: March 2009
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01022528

Locations
Canada, Ontario
Women's College Hospital
Toronto, Ontario, Canada, M5S 1B2
Sponsors and Collaborators
Women's College Hospital
  More Information

No publications provided

Responsible Party: Women's College Hospital
ClinicalTrials.gov Identifier: NCT01022528     History of Changes
Other Study ID Numbers: 2009-0005-B
Study First Received: November 27, 2009
Last Updated: October 15, 2013
Health Authority: Canada: Ethics Review Committee

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:
Fatigue
Pain, Postoperative
Vomiting
Postoperative Nausea and Vomiting
Signs and Symptoms
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms, Digestive
Nausea
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on April 17, 2014