NCT00695487

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
320

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 10, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 12, 2008

Completed
19 days until next milestone

Study Start

First participant enrolled

July 1, 2008

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

March 12, 2014

Status Verified

March 1, 2014

Enrollment Period

2.4 years

First QC Date

June 10, 2008

Last Update Submit

March 11, 2014

Conditions

NauseaVomiting

Keywords

AnesthesiaTHCPostoperative Nausea

Outcome Measures

Primary Outcomes (1)

  • Absence of postoperative Nausea and Vomiting

    0-24h after Operation

Secondary Outcomes (1)

  • Psychological and physiological data after ingestion of THC Analgetics required

    0-24h after operation

Study Arms (2)

1

EXPERIMENTAL

Receives 0.125mg/kg THC before emergence

Drug: THC 9-d-tetra hydro cannabinol

2

PLACEBO COMPARATOR

Receives NaCl before emergence

Drug: THC 9-d-tetra hydro cannabinol

Interventions

THC 9-d-tetra hydro cannabinolDRUG

0.125mg/kg iv one time

12

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ASA I-III
  • elective open and laparoscopic surgery \>1hour

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Inselspital, Bern University Hospital

Bern, Canton of Bern, 3010, Switzerland

Location

MeSH Terms

Conditions

NauseaVomitingPostoperative Nausea and Vomiting

Interventions

Dronabinol

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsPostoperative ComplicationsPathologic Processes

Intervention Hierarchy (Ancestors)

CannabinoidsTerpenesHydrocarbonsOrganic Chemicals

Study Officials

  • Robert Greif, MD

    Department of Anesthesia, Bern University Hospital , Switzerland

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 10, 2008

First Posted

June 12, 2008

Study Start

July 1, 2008

Primary Completion

December 1, 2010

Study Completion

December 1, 2011

Last Updated

March 12, 2014

Record last verified: 2014-03

Locations

CH(1)