Does Intravenous Cannabis Reduce Postoperative Nausea and Vomiting (PONV)? - Full Text View

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. )

First Received on June 10, 2008. Last Updated on February 4, 2010 History of Changes

Sponsor:	University Hospital Inselspital, Berne
Information provided by:	University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier:	NCT00695487

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:

MedlinePlus related topics: Nausea and Vomiting

Drug Information available for: Cannabinol Cannabis

U.S. FDA Resources

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 ]

Estimated Enrollment:	320
Study Start Date:	July 2008
Estimated Study Completion Date:	June 2010
Primary Completion Date:	December 2009 (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

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:	Robert Greif, M.D. Associate Professor, Department of Anaesthesia, Inselspital, Bern University Hospital, Switzerland
ClinicalTrials.gov Identifier:	NCT00695487 History of Changes
Other Study ID Numbers:	KEK240_07, THC-001
Study First Received:	June 10, 2008
Last Updated:	February 4, 2010
Health Authority:	Switzerland: Federal Office of Public Health

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

ClinicalTrials.gov processed this record on February 13, 2012