Efficacy of Low Dose Promethazine for Postoperative Nausea and Vomiting

This study has been terminated.
(Population of interest was no longer available)
Sponsor:
Information provided by:
Women's College Hospital
ClinicalTrials.gov Identifier:
NCT01159548
First received: July 7, 2010
Last updated: July 26, 2011
Last verified: July 2011
  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

Resource links provided by NLM:


Further study details as provided by Women's College Hospital:

Primary Outcome Measures:
  • 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
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01159548

Locations
Canada, Ontario
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
  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 July 29, 2014