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

This study has been terminated.
(In the intermediate analysis, no effect could be shown, not even a tendency.)
Sponsor:
Information provided by (Responsible Party):
University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier:
NCT00695487
First received: June 10, 2008
Last updated: March 11, 2014
Last verified: March 2014
  Purpose

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 Intervention
Nausea
Vomiting
Drug: THC 9-d-tetra hydro cannabinol

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Does Intravenous Cannabis Reduce Postoperative Nausea and Vomiting (PONV)?

Resource links provided by NLM:


Further study details as provided by University Hospital Inselspital, Berne:

Primary Outcome Measures:
  • Absence of postoperative Nausea and Vomiting [ Time Frame: 0-24h after Operation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Psychological and physiological data after ingestion of THC Analgetics required [ Time Frame: 0-24h after operation ] [ Designated as safety issue: Yes ]

Enrollment: 320
Study Start Date: July 2008
Study Completion Date: December 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
  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: 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
  More Information

No publications provided

Responsible Party: University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier: NCT00695487     History of Changes
Other Study ID Numbers: KEK240_07, THC-001
Study First Received: June 10, 2008
Last Updated: March 11, 2014
Health Authority: Switzerland: Federal Office of Public Health

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

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

ClinicalTrials.gov processed this record on November 25, 2014