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

• Sponsor: University Hospital Inselspital, Berne (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00695487
• Collaborator: (none)
• Enrollment: 320
• Location: 1
• Arms: 2
• Duration (Months): 41
• Patients Per Site Per Month: 7.8

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Nausea; Vomiting	Drug: THC 9-d-tetra hydro cannabinol	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 320 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Does Intravenous Cannabis Reduce Postoperative Nausea and Vomiting (PONV)?
• Study Start Date: Jul 1, 2008
• Actual Primary Completion Date: Dec 1, 2010
• Actual Study Completion Date: Dec 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. Absence of postoperative Nausea and Vomiting [0-24h after Operation]

Secondary Outcome Measures

1. Psychological and physiological data after ingestion of THC Analgetics required [0-24h after operation]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Hospital Inselspital, Berne
• ClinicalTrials.gov Identifier: NCT00695487
• Other Study ID Numbers: KEK240_07; THC-001
• First Posted: Jun 12, 2008
• Last Update Posted: Mar 12, 2014
• Last Verified: Mar 1, 2014

• Keywords provided by University Hospital Inselspital, Berne: Anesthesia; THC; Postoperative Nausea
• Additional relevant MeSH terms: Nausea; Vomiting; Postoperative Nausea and Vomiting

Study Results

No Results Posted as of Mar 12, 2014