- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00695487
Does Intravenous Cannabis Reduce Postoperative Nausea and Vomiting (PONV)? (THC)
March 11, 2014 updated by: University Hospital Inselspital, Berne
The investigators evaluate if intravenously applied THC (Cannabis) reduces postoperative Nausea and vomiting.
THC will be given during anesthesia before emergence.
We measure how long and how effective it reduces PONV
Study Overview
Status
Terminated
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
320
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Bern, Switzerland, 3010
- Inselspital, Bern University Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 68 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- ASA I-III
- elective open and laparoscopic surgery >1hour
Exclusion Criteria:
- ambulatory surgery
- pregnancy, breast feeding
- >ASA III
- BMI >35
- antipsychotic, antiemetic, cytostatic therapy
- major cardiovascular, renal, hepatic, central nervous system disease
- current chronic cannabis consumption and hard drug abuse
- schizophrenia
- preoperative nausea and vomiting, vestibular disease
- not speaking german or french
- refusal to participate
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
Receives 0.125mg/kg THC before emergence
|
0.125mg/kg iv one time
|
Placebo Comparator: 2
Receives NaCl before emergence
|
0.125mg/kg iv one time
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Absence of postoperative Nausea and Vomiting
Time Frame: 0-24h after Operation
|
0-24h after Operation
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Psychological and physiological data after ingestion of THC Analgetics required
Time Frame: 0-24h after operation
|
0-24h after operation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Robert Greif, MD, Department of Anesthesia, Bern University Hospital , Switzerland
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2008
Primary Completion (Actual)
December 1, 2010
Study Completion (Actual)
December 1, 2011
Study Registration Dates
First Submitted
June 10, 2008
First Submitted That Met QC Criteria
June 11, 2008
First Posted (Estimate)
June 12, 2008
Study Record Updates
Last Update Posted (Estimate)
March 12, 2014
Last Update Submitted That Met QC Criteria
March 11, 2014
Last Verified
March 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- KEK240_07
- THC-001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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