An interventional study of Dexamethasone (0.1 mg/kg) and Dexamethasone (0.2 mg/kg) in Postoperative Pain, Postoperative Nausea and Vomiting and Fatigue, sponsored by Women's College Hospital. Completed at 1 site in Canada. Open to female participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2013-10-17.
Sponsored by Women's College Hospital · Not applicable, Interventional, and Treatment
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.
5,224 studies on the registry are indexed under Pain, Postoperative; 1,154 are open to participants now.
This study's enrollment of 138 is above the median of 75 across 4,457 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →Women's College Hospital is the lead sponsor of 87 studies on the registry; 18 are open to participants now.
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Drug: Dexamethasone (0.1 mg/kg) · Drug: Dexamethasone (0.2 mg/kg)
Other: Saline
Drug page: Dexamethasone
Also known as: Dose = 0.1 mg/kg
Drug page: Dexamethasone
Also known as: Dose = 0.2 mg/kg
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
The record gives a start of Mar 2009, a primary completion of Dec 2012 and a completion of Dec 2012. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Oct 2013. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Dexamethasone
Women's College Hospital