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

Primary Purpose

Nausea, Vomiting

Status
Terminated
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
THC 9-d-tetra hydro cannabinol
Sponsored by
Insel Gruppe AG, University Hospital Bern
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nausea focused on measuring Anesthesia, THC, Postoperative Nausea

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Inselspital, Bern University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

Receives 0.125mg/kg THC before emergence

Receives NaCl before emergence

Outcomes

Primary Outcome Measures

Absence of postoperative Nausea and Vomiting

Secondary Outcome Measures

Psychological and physiological data after ingestion of THC Analgetics required

Full Information

First Posted
June 10, 2008
Last Updated
March 11, 2014
Sponsor
Insel Gruppe AG, University Hospital Bern
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1. Study Identification

Unique Protocol Identification Number
NCT00695487
Brief Title
Does Intravenous Cannabis Reduce Postoperative Nausea and Vomiting (PONV)?
Acronym
THC
Official Title
Does Intravenous Cannabis Reduce Postoperative Nausea and Vomiting (PONV)?
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Terminated
Why Stopped
In the intermediate analysis, no effect could be shown, not even a tendency.
Study Start Date
July 2008 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Insel Gruppe AG, University Hospital Bern

4. Oversight

Data Monitoring Committee
No

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nausea, Vomiting
Keywords
Anesthesia, THC, Postoperative Nausea

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
320 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Receives 0.125mg/kg THC before emergence
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Receives NaCl before emergence
Intervention Type
Drug
Intervention Name(s)
THC 9-d-tetra hydro cannabinol
Intervention Description
0.125mg/kg iv one time
Primary Outcome Measure Information:
Title
Absence of postoperative Nausea and Vomiting
Time Frame
0-24h after Operation
Secondary Outcome Measure Information:
Title
Psychological and physiological data after ingestion of THC Analgetics required
Time Frame
0-24h after operation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Greif, MD
Organizational Affiliation
Department of Anesthesia, Bern University Hospital , Switzerland
Official's Role
Study Director
Facility Information:
Facility Name
Inselspital, Bern University Hospital
City
Bern
ZIP/Postal Code
3010
Country
Switzerland

12. IPD Sharing Statement

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

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