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

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ClinicalTrials.gov Identifier: NCT00695487
Recruitment Status : Terminated (In the intermediate analysis, no effect could be shown, not even a tendency.)
First Posted : June 12, 2008
Last Update Posted : March 12, 2014
Sponsor:
Information provided by (Responsible Party):
University Hospital Inselspital, Berne

Tracking Information
First Submitted Date  ICMJE June 10, 2008
First Posted Date  ICMJE June 12, 2008
Last Update Posted Date March 12, 2014
Study Start Date  ICMJE July 2008
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 11, 2008)
Absence of postoperative Nausea and Vomiting [ Time Frame: 0-24h after Operation ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 11, 2008)
Psychological and physiological data after ingestion of THC Analgetics required [ Time Frame: 0-24h after operation ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Does Intravenous Cannabis Reduce Postoperative Nausea and Vomiting (PONV)?
Official Title  ICMJE 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 Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Nausea
  • Vomiting
Intervention  ICMJE Drug: THC 9-d-tetra hydro cannabinol
0.125mg/kg iv one time
Study Arms  ICMJE
  • Experimental: 1
    Receives 0.125mg/kg THC before emergence
    Intervention: Drug: THC 9-d-tetra hydro cannabinol
  • Placebo Comparator: 2
    Receives NaCl before emergence
    Intervention: Drug: THC 9-d-tetra hydro cannabinol
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: June 11, 2008)
320
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2011
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00695487
Other Study ID Numbers  ICMJE KEK240_07
THC-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Hospital Inselspital, Berne
Study Sponsor  ICMJE University Hospital Inselspital, Berne
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Robert Greif, MD Department of Anesthesia, Bern University Hospital , Switzerland
PRS Account University Hospital Inselspital, Berne
Verification Date March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP