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

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

Tracking Information
First Submitted Date  ICMJE November 27, 2009
First Posted Date  ICMJE December 1, 2009
Last Update Posted Date October 17, 2013
Study Start Date  ICMJE March 2009
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 30, 2009)
Total cumulative morphine consumption via the patient-controlled analgesia (PCA) pump in the first 24 hours
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01022528 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 30, 2009)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Analgesic Effect of Preoperative Dexamethasone in Gynecological Laparotomies - a Dose-ranging Study
Official Title  ICMJE Not Provided
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Postoperative Pain
  • Postoperative Nausea and Vomiting
  • Fatigue
Intervention  ICMJE
  • 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
  • Other: Saline
Study Arms  ICMJE
  • Experimental: Dexamethasone
    Interventions:
    • Drug: Dexamethasone (0.1 mg/kg)
    • Drug: Dexamethasone (0.2 mg/kg)
  • Placebo Comparator: Saline
    Intervention: Other: Saline
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 30, 2009)
138
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2012
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01022528
Other Study ID Numbers  ICMJE 2009-0005-B
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Women's College Hospital
Study Sponsor  ICMJE Women's College Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Women's College Hospital
Verification Date October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP