Status:
TERMINATED
Efficacy of Low Dose Promethazine for Postoperative Nausea and Vomiting
Lead Sponsor:
Women's College Hospital
Conditions:
Ambulatory Gynecological Laparoscopic Procedures
Eligibility:
FEMALE
18-60 years
Phase:
NA
Brief Summary
There has been an increase in ambulatory surgical procedures performed across Canada; ambulatory procedures account for almost 70% of all surgeries. Postoperative nausea and vomiting (PONV) and pain a...
Eligibility Criteria
Inclusion
- 1\. Patient is between 18 - 60 yrs of age
- 2 Patient's health is graded as class I-III according to the American Society of Anesthesiologists physical status classification.
- 3\. The patient has 2 or more of the following risk factors:
- Female
- Non-smoker
- History of PONV/motion sickness
- Use of post-operative opioids (current surgery)
- 4\. Undergoing ambulatory gynecological laparoscopic procedures of at least 30 minutes duration
Exclusion
- preexisting nausea, vomiting or retching, gastric outlet or intestinal obstruction
- clinical evidence of a difficult airway
- obesity (body mass index \> 40 kg m-2)
- scheduled to receive propofol for anesthesia maintenance
- current pregnancy
- psychiatric illness
- clinically significant major organic disease
- preoperative QTc interval \> 440 ms on electrocardiogram
- known hypersensitivity to promethazine, granisetron, ondansetron or other 5 HT3-receptor antagonists
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2012
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT01159548
Start Date
July 1 2010
End Date
July 1 2012
Last Update
July 27 2011
Active Locations (1)
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1
Women's College Hospital
Toronto, Ontario, Canada, M5S 1B2