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

NCT ID: NCT00695487

Last Updated: 2014-03-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

320 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2011-12-31

Brief Summary

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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

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Conditions

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Nausea Vomiting

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Receives 0.125mg/kg THC before emergence

Group Type EXPERIMENTAL

THC 9-d-tetra hydro cannabinol

Intervention Type DRUG

0.125mg/kg iv one time

2

Receives NaCl before emergence

Group Type PLACEBO_COMPARATOR

THC 9-d-tetra hydro cannabinol

Intervention Type DRUG

0.125mg/kg iv one time

Interventions

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THC 9-d-tetra hydro cannabinol

0.125mg/kg iv one time

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Robert Greif, MD

Role: STUDY_DIRECTOR

Department of Anesthesia, Bern University Hospital , Switzerland

Locations

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Inselspital, Bern University Hospital

Bern, Canton of Bern, Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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THC-001

Identifier Type: -

Identifier Source: secondary_id

KEK240_07

Identifier Type: -

Identifier Source: org_study_id

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