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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

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

Condition or disease Intervention/treatment Phase
Nausea Vomiting Drug: THC 9-d-tetra hydro cannabinol Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 320 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Does Intravenous Cannabis Reduce Postoperative Nausea and Vomiting (PONV)?
Study Start Date : July 2008
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
Receives 0.125mg/kg THC before emergence
Drug: THC 9-d-tetra hydro cannabinol
0.125mg/kg iv one time
Placebo Comparator: 2
Receives NaCl before emergence
Drug: THC 9-d-tetra hydro cannabinol
0.125mg/kg iv one time



Primary Outcome Measures :
  1. Absence of postoperative Nausea and Vomiting [ Time Frame: 0-24h after Operation ]

Secondary Outcome Measures :
  1. Psychological and physiological data after ingestion of THC Analgetics required [ Time Frame: 0-24h after operation ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00695487


Locations
Switzerland
Inselspital, Bern University Hospital
Bern, Switzerland, 3010
Sponsors and Collaborators
University Hospital Inselspital, Berne
Investigators
Study Director: Robert Greif, MD Department of Anesthesia, Bern University Hospital , Switzerland

Responsible Party: University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier: NCT00695487     History of Changes
Other Study ID Numbers: KEK240_07
THC-001
First Posted: June 12, 2008    Key Record Dates
Last Update Posted: March 12, 2014
Last Verified: March 2014

Keywords provided by University Hospital Inselspital, Berne:
Anesthesia
THC
Postoperative Nausea

Additional relevant MeSH terms:
Nausea
Vomiting
Postoperative Nausea and Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Postoperative Complications
Pathologic Processes