Clonidine-Remifentanil. Effect of the Combination on Acut... | NCT00730054

Studies
Clonidine-Remifentanil. Effect of the Combination on Acute Pain and Respiration in Healthy Volunteers

NCT00730054

Sponsor

Oslo University Hospital

Status

Completed

Last Update Posted

Jul 6, 2011Estimated

Enrollment

12Actual

Phase

Phase 1Phase 2

Conditions

Acute Pain
Respiration
Sedation

Interventions

Remifentanil+clonidine

Countries

Norway

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

Status Module

Record Verification Date

Aug 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2005

Primary Completion Date

May 2005Actual

Completion Date

May 2005Actual

First Submitted Date

Aug 6, 2008

First Submission Date that Met QC Criteria

Aug 7, 2008

First Posted Date

Aug 8, 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

Jul 3, 2011

Last Update Posted Date

Jul 6, 2011Estimated

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 hypothesis is that systemic remifentanil and Clonidine act in a synergistic manner to relief acute main in an experimental human pain model. Of interest is also the effect of the combination on respiration, sedation and cognitive behavior.

Detailed Description

To examine the possible synergistic effects og systemic remifentanil and clonidine. Its effects on respiration, cognitive function and sedation.

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

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

12Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Active Comparator	Clonidine	Drug: Remifentanil+clonidine
2	Active Comparator	Remifentanil	Drug: Remifentanil+clonidine
4	Experimental	Remifentanil+clonidine	Drug: Remifentanil+clonidine
3	Placebo Comparator	Placebo	Drug: Remifentanil+clonidine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Remifentanil+clonidine	Drug	iv Remifentanil+ iv clonidine	1 2 3 4

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Relief of pain(VAS reduction)		Experimental

Secondary Outcomes

Measure	Description	Time Frame
Reduction in Minute ventilation		Experimental
Reduction in CO2 stimulated Minute Ventilation		experimental
Reduction in BIS score

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy volunteers

Exclusion Criteria:

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jon B Bergmann, Ass. Prof.	Dep of Anesthesia and Intensive Care, Rikshospitalet-Radiumhospitalet Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dep of Anesthesia and Intensive Care, Rikshospitalet-Radiumhospitalet Medical Center		Oslo		0027	Norway

Condition Browse Module

MeSH Terms

ID	Term
D059787	Acute Pain
D053120	Respiratory Aspiration

Ancestor Terms

ID	Term
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077208	Remifentanil
D003000	Clonidine

Ancestor Terms

ID	Term
D011422	Propionates
D000144	Acids, Acyclic
D002264	Carboxylic Acids
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided