Ambulatory Gynecological Laparoscopic Procedures Clinical Trial
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.
| Status | Terminated |
| Enrollment | 400 |
| Est. completion date | July 2012 |
| Est. primary completion date | July 2012 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years to 60 Years |
| Eligibility |
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 |
Allocation: Randomized, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
| Country | Name | City | State |
|---|---|---|---|
| Canada | Women's College Hospital | Toronto | Ontario |
| Lead Sponsor | Collaborator |
|---|---|
| Women's College Hospital |
Canada,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Absence of emetic episode for 24 h in the postoperative period |