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

Nausea Clinical Trial

— THC  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00695487
• Other study ID #: KEK240_07
• Secondary ID: THC-001
• Status: Terminated
• Phase: N/A
• First received: June 10, 2008
• Last updated: March 11, 2014
• Start date: July 2008
• Est. completion date: December 2011

Study information

• Verified date: March 2014
• Source: University Hospital Inselspital, Berne
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Federal Office of Public Health
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 320
• Est. completion date: December 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Nausea
• Postoperative Nausea and Vomiting
• Vomiting

Intervention

Drug:
• THC 9-d-tetra hydro cannabinol
0.125mg/kg iv one time

Locations

Country	Name	City	State
Switzerland	Inselspital, Bern University Hospital	Bern

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Inselspital, Berne

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Absence of postoperative Nausea and Vomiting		0-24h after Operation	No
Secondary	Psychological and physiological data after ingestion of THC Analgetics required		0-24h after operation	Yes