Does Intravenous Cannabis Reduce Postoperative Nausea and... | NCT00695487

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

NCT00695487

Sponsor

Insel Gruppe AG, University Hospital Bern

Status

Terminated

Last Update Posted

Mar 12, 2014Estimated

Enrollment

320Actual

Phase

Not Applicable

Conditions

Nausea
Vomiting

Interventions

THC 9-d-tetra hydro cannabinol

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
THC-001

Status Module

Record Verification Date

Mar 2014

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

In the intermediate analysis, no effect could be shown, not even a tendency.

Expanded Access Info

Start Date

Jul 2008

Primary Completion Date

Dec 2010Actual

Completion Date

Dec 2011Actual

First Submitted Date

Jun 10, 2008

First Submission Date that Met QC Criteria

Jun 11, 2008

First Posted Date

Jun 12, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 11, 2014

Last Update Posted Date

Mar 12, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

320Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
THC 9-d-tetra hydro cannabinol	Drug	0.125mg/kg iv one time	1 2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Absence of postoperative Nausea and Vomiting		0-24h after Operation

Secondary Outcomes

Measure	Description	Time Frame
Psychological and physiological data after ingestion of THC Analgetics required		0-24h after operation

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Robert Greif, MD	Department of Anesthesia, Bern University Hospital , Switzerland	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Inselspital, Bern University Hospital		Bern	Canton of Bern	3010	Switzerland

Condition Browse Module

MeSH Terms

ID	Term
D009325	Nausea
D014839	Vomiting
D020250	Postoperative Nausea and Vomiting

Ancestor Terms

ID	Term
D012817	Signs and Symptoms, Digestive
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D011183	Postoperative Complications

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D013759	Dronabinol

Ancestor Terms

ID	Term
D002186	Cannabinoids
D013729	Terpenes
D006838	Hydrocarbons
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided