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Efficacy of Low Dose Promethazine for Postoperative Nausea and Vomiting

This study has been terminated.
(Population of interest was no longer available)
Sponsor:
Information provided by:
Women's College Hospital
ClinicalTrials.gov Identifier:
NCT01159548
First received: July 7, 2010
Last updated: July 26, 2011
Last verified: July 2011

July 7, 2010
July 26, 2011
July 2010
July 2012   (final data collection date for primary outcome measure)
Absence of emetic episode for 24 h in the postoperative period
Same as current
Complete list of historical versions of study NCT01159548 on ClinicalTrials.gov Archive Site
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Efficacy of Low Dose Promethazine for Postoperative Nausea and Vomiting
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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 are the most frequently reported adverse events by patients prior to discharge after ambulatory surgery. The incidence can be as high as 70 to 80% in high-risk patients.

PONV is a cause of morbidity particularly in gynecological procedures and the incidence of patients experiencing PONV is as high as 58-75%. Apart from delayed recovery, the occurrence of PONV has been linked to gastric aspiration, psychological distress and wound dehiscence. The occurrence of PONV delays patient discharge and further more is a leading cause of unexpected admission after ambulatory anesthesia

Promethazine, is an antiemetic medication that has been widely used over the last 50 years, and although effective at reducing PONV, it tends to cause sedation. In this study, we are trying to determine if a smaller dose of promethazine, in addition to the standard treatment for post-surgical nausea and vomiting, will be more beneficial than the standard treatment on its own.

It is hypothesized that the use of low dose promethazine (3 mg) as part of a multimodal antiemetic regimen will be efficacious in preventing PONV without the sedative effects of promethazine.

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Interventional
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Allocation: Randomized
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Ambulatory Gynecological Laparoscopic Procedures
Drug: Promethazine
  • No Intervention: Saline
  • Promethazine 6.25 mg
    Intervention: Drug: Promethazine
  • Promethazine 3 mg
    Intervention: Drug: Promethazine
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
400
July 2012
July 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

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 Criteria:

  • 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
Female
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01159548
2009-0034B
No
Dr. Jean Kronberg, Women's College Hospital
Women's College Hospital
Not Provided
Principal Investigator: Jean Kronberg, MD, PhD Women's College Hospital
Women's College Hospital
July 2011

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