Efficacy of Low Dose Promethazine for Postoperative Nausea and Vomiting

NCT ID: NCT01159548

Last Updated: 2011-07-27

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-07-31
• Study Completion Date: 2012-07-31

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 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.

Conditions

Ambulatory Gynecological Laparoscopic Procedures

Study Design

• Allocation Method: RANDOMIZED
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Saline

Group Type: NO_INTERVENTION

No interventions assigned to this group

Promethazine 6.25 mg

Group Type: OTHER

Promethazine

Intervention Type: DRUG

Promethazine 3 mg

Group Type: OTHER

Promethazine

Intervention Type: DRUG

Interventions

Promethazine

Intervention Type: DRUG

Promethazine

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Women's College Hospital

OTHER

Sponsor Role: lead

Responsible Party

Women's College Hospital

Principal Investigators

Jean Kronberg, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Women's College Hospital

Locations

Women's College Hospital

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

2009-0034B

Identifier Type: -

Identifier Source: org_study_id