Efficacy of Low Dose Promethazine for Postoperative Nausea and Vomiting
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention |
|---|---|
|
Ambulatory Gynecological Laparoscopic Procedures |
Drug: Promethazine |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
- Absence of emetic episode for 24 h in the postoperative period
| Estimated Enrollment: | 400 |
| Study Start Date: | July 2010 |
| Estimated Study Completion Date: | July 2012 |
| Estimated Primary Completion Date: | July 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| No Intervention: Saline | |
| Promethazine 6.25 mg | Drug: Promethazine |
| Promethazine 3 mg | Drug: Promethazine |
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
More Information
No publications provided
| Responsible Party: | Dr. Jean Kronberg, Women's College Hospital |
| ClinicalTrials.gov Identifier: | NCT01159548 History of Changes |
| Other Study ID Numbers: | 2009-0034B |
| Study First Received: | July 7, 2010 |
| Last Updated: | July 26, 2011 |
| Health Authority: | Canada: Women's College Hospital Reserach Ethics Board |
Additional relevant MeSH terms:
|
Postoperative Nausea and Vomiting Postoperative Complications Pathologic Processes Nausea Signs and Symptoms, Digestive Signs and Symptoms Vomiting Promethazine Diphenhydramine Antipruritics Dermatologic Agents Therapeutic Uses Pharmacologic Actions Histamine H1 Antagonists Histamine Antagonists |
Histamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Anti-Allergic Agents Antiemetics Autonomic Agents Peripheral Nervous System Agents Central Nervous System Agents Gastrointestinal Agents Hypnotics and Sedatives Central Nervous System Depressants Anesthetics, Local Anesthetics Sensory System Agents |
ClinicalTrials.gov processed this record on May 21, 2013