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
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||138 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Study Start Date :||March 2009|
|Actual Primary Completion Date :||December 2012|
|Actual Study Completion Date :||December 2012|
Drug: Dexamethasone (0.1 mg/kg)
Other Name: Dose = 0.1 mg/kgDrug: Dexamethasone (0.2 mg/kg)
Other Name: Dose = 0.2 mg/kg
|Placebo Comparator: Saline||Other: Saline|
- Total cumulative morphine consumption via the patient-controlled analgesia (PCA) pump in the first 24 hours
- 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
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 ClinicalTrials.gov identifier (NCT number): NCT01022528
|Women's College Hospital|
|Toronto, Ontario, Canada, M5S 1B2|