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

Tracking Information

First Received Date ^ICMJE

June 10, 2008

Last Updated Date

April 27, 2009

Start Date ^ICMJE

July 2008

Estimated Primary Completion Date

January 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00695487 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

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

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Nausea
Vomiting

Intervention ^ICMJE

Drug: THC 9-d-tetra hydro cannabinol

Study Arms / Comparison Groups

Experimental: Receives 0.125mg/kg THC before emergence
Placebo Comparator: Receives NaCl before emergence

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

320

Estimated Completion Date

June 2010

Estimated Primary Completion Date

January 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

Gender

Both

Ages

18 Years to 70 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

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

Location Countries ^ICMJE

Switzerland

Administrative Information

NCT ID ^ICMJE

NCT00695487

Responsible Party

Robert Greif, M.D. Associate Professor, Department of Anaesthesia, Inselspital, Bern University Hospital, Switzerland

Study ID Numbers ^ICMJE

KEK240_07, THC-001

Study Sponsor ^ICMJE

University Hospital Inselspital, Berne

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Robert Greif, MD

Department of Anesthesia, Bern University Hospital , Switzerland

Information Provided By

University Hospital Inselspital, Berne

Verification Date

April 2009

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