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Does Intravenous Cannabis Reduce Postoperative Nausea and Vomiting (PONV)? (THC)

This study is currently recruiting participants.
Study NCT00695487.   Last updated on August 22, 2008.   Information provided by University Hospital Inselspital, Berne

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Descriptive Information Fields
Brief Title  Does Intravenous Cannabis Reduce Postoperative Nausea and Vomiting (PONV)?
Official Title  Does Intravenous Cannabis Reduce Postoperative Nausea and Vomiting (PONV)?
Brief Summary

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

Detailed Description
Study Phase
Study Type  Interventional
Study Design  Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Primary Outcome Measure  Absence of postoperative Nausea and Vomiting [ Time Frame: 0-24h after Operation ] [ Designated as safety issue: No ]
Secondary Outcome Measure  Psychological and physiological data after ingestion of THC Analgetics required [ Time Frame: 0-24h after operation ] [ Designated as safety issue: Yes ]
Condition  Nausea
Vomiting
Intervention  Drug: THC 9-d-tetra hydro cannabinol
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status  Recruiting
Enrollment  320
Start Date  July 2008
Completion Date June 2010
Eligibility Criteria 

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
Gender Both
Ages 18 Years to 70 Years
Accepts Healthy Volunteers No
Contacts ††
Contact: Robert Greif, MD     0041 31 6321629     robert.greif@insel.ch    
Contact: Lorenz G Theiler, MD     0041 31 6321629     lorenz.theiler@insel.ch    
Location Countries  Switzerland
Administrative Information Fields
NCT ID  NCT00695487
Organization ID KEK240_07
Secondary IDs †† THC-001
Study Sponsor  University Hospital Inselspital, Berne
Collaborators ††
Investigators 
Study Director:     Robert Greif, MD     Department of Anesthesia, Bern University Hospital , Switzerland    
Information Provided By University Hospital Inselspital, Berne
Verification Date August 2008
First Received Date  June 10, 2008
Last Updated Date August 22, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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