NCT01022528

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 138 (actual)
• Sponsor: Women's College Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Postoperative Pain
• Postoperative Nausea and Vomiting
• Fatigue

Interventions

Type	Name	Description
DRUG	Dexamethasone (0.1 mg/kg)
DRUG	Dexamethasone (0.2 mg/kg)
OTHER	Saline

Timeline

• Start date: 2009-03-01
• Primary completion: 2012-12-01
• Completion: 2012-12-01
• First posted: 2009-12-01
• Last updated: 2013-10-17

Locations

1 site across 1 country: Canada