Efficacy of Low Dose Promethazine for Postoperative Nausea and Vomiting

Sponsor

Women's College Hospital (Other)

Overall Status

Terminated

CT.gov ID

NCT01159548

Collaborator

(none)

400

Enrollment

Location

Arms

Duration (Months)

16.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Ambulatory Gynecological Laparoscopic Procedures	Drug: Promethazine Drug: Promethazine	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

400 participants

Allocation:

Randomized

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Study Start Date :

Jul 1, 2010

Anticipated Primary Completion Date :

Jul 1, 2012

Anticipated Study Completion Date :

Jul 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Saline
Other: Promethazine 6.25 mg	Drug: Promethazine
Other: Promethazine 3 mg	Drug: Promethazine

Arm

Intervention/Treatment

No Intervention: Saline

Other: Promethazine 6.25 mg

Drug: Promethazine

Other: Promethazine 3 mg

Drug: Promethazine

Outcome Measures

Primary Outcome Measures

Absence of emetic episode for 24 h in the postoperative period []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

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.

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)

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

Locations

	Site	City	State	Country	Postal Code
1	Women's College Hospital	Toronto	Ontario	Canada	M5S 1B2

Sponsors and Collaborators

Women's College Hospital

Investigators

Principal Investigator: Jean Kronberg, MD, PhD, Women's College Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT01159548

Other Study ID Numbers:

2009-0034B

First Posted:

Jul 9, 2010

Last Update Posted:

Jul 27, 2011

Last Verified:

Jul 1, 2011

Additional relevant MeSH terms:

Promethazine

Diphenhydramine

Study Results

No Results Posted as of Jul 27, 2011