Efficacy of Low Dose Promethazine for Postoperative Nausea and Vomiting

NCT01159548 | Terminated

• 1 other identifier: 2009-0034B
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Absence of emetic episode for 24 h in the postoperative period

Study Arms (3)

Saline

NO INTERVENTION

Promethazine 6.25 mg

OTHER

Drug: Promethazine

Promethazine 3 mg

OTHER

Drug: Promethazine

Interventions

Promethazine DRUG

Promethazine 6.25 mg

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \. Patient is between 18 - 60 yrs of age
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Women's College Hospital: lead

Study Sites (1)

Women's College Hospital

Toronto, Ontario, M5S 1B2, Canada

Location

MeSH Terms

Interventions

Promethazine

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Phenothiazines; Sulfur Compounds; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Jean Kronberg, MD, PhD

  Women's College Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 7, 2010
• First Posted: July 9, 2010
• Study Start: July 1, 2010
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: July 27, 2011

Record last verified: 2011-07

Locations

CA (1)