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

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

This study is currently recruiting participants.

Verified by University Hospital Inselspital, Berne, April 2009

First Received: June 10, 2008 Last Updated: April 27, 2009 History of Changes

Sponsored by:	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:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Does Intravenous Cannabis Reduce Postoperative Nausea and Vomiting (PONV)?

Resource links provided by NLM:

MedlinePlus related topics: Anesthesia 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
Estimated Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Receives 0.125mg/kg THC before emergence	Drug: THC 9-d-tetra hydro cannabinol 0.125mg/kg iv one time
2: Placebo Comparator 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

Contacts

Contact: Robert Greif, MD	0041 31 6321629	robert.greif@insel.ch
Contact: Lorenz G Theiler, MD	0041 31 6321629	lorenz.theiler@insel.ch

Locations

Switzerland
Inselspital, Bern University Hospital	Recruiting
Bern, Switzerland, 3010
Contact: Robert Greif, MD 0041316322111 robert.greif@insel.ch
Contact: Lorenz G Theiler, MD 0041316322111 loren.theiler@insel.ch

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:	Department of Anaesthesia, Inselspital, Bern University Hospital, Switzerland ( Robert Greif, M.D. Associate Professor )
Study ID Numbers:	KEK240_07, THC-001
Study First Received:	June 10, 2008
Last Updated:	April 27, 2009
ClinicalTrials.gov Identifier:	NCT00695487 History of Changes
Health Authority:	Switzerland: Federal Office of Public Health

Keywords provided by University Hospital Inselspital, Berne:

Anesthesia
THC
Postoperative Nausea

Study placed in the following topic categories:

Signs and Symptoms
Postoperative Nausea and Vomiting
Vomiting
Postoperative Complications

Signs and Symptoms, Digestive
Anesthetics
Nausea

Additional relevant MeSH terms:

Signs and Symptoms
Postoperative Nausea and Vomiting
Pathologic Processes
Vomiting

Postoperative Complications
Signs and Symptoms, Digestive
Nausea

ClinicalTrials.gov processed this record on July 06, 2009