Efficacy of Low Dose Promethazine for Postoperative Nausea and Vomiting

Women's College Hospital

Status: Terminated

Conditions: Ambulatory Gynecological Laparoscopic Procedures

Treatments: Drug: Promethazine

Study type: Interventional

Funder types: Other

Identifiers

NCT01159548

2009-0034B

Details and patient eligibility

About

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.

Enrollment: 400 estimated patients

Sex: Female

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

400 participants in 3 patient groups

Saline

No Intervention group

Promethazine 6.25 mg

Other group

Treatment:

Drug: Promethazine

Drug: Promethazine

Promethazine 3 mg

Other group

Treatment:

Drug: Promethazine

Drug: Promethazine