Requirement of Analgesics After Two Remifentanil Dosing R... | NCT00757198

Studies
Requirement of Analgesics After Two Remifentanil Dosing Regimen in Cardiac Surgery.

NCT00757198

Sponsor

Kuopio University Hospital

Status

Completed

Last Update Posted

Sep 12, 2013Estimated

Enrollment

90Actual

Phase

Phase 4

Conditions

Pain

Interventions

remifentanil
remifentanil

Countries

Finland

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
EudraCT 2008-000597-21

Status Module

Record Verification Date

Sep 2013

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

Sep 2008

Primary Completion Date

Nov 2011Actual

Completion Date

Dec 2011Actual

First Submitted Date

Sep 22, 2008

First Submission Date that Met QC Criteria

Sep 22, 2008

First Posted Date

Sep 23, 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

Sep 11, 2013

Last Update Posted Date

Sep 12, 2013Estimated

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

Prospective double blind study comparing two remifentanil dosing protocols (0.1 and 0.3 mcg/kg/min) during cardiac surgery. Main outcome measures are postoperative opioid requirements (PCA oxycodone) and postoperative pain (VAS, verbal rating scale).

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

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

90Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	remifentanil o.1 mcg/kg/min	Drug: remifentanil
2	Active Comparator	remifentanil 0.3 mcg/kg/min	Drug: remifentanil

Interventions

Name	Type	Description	Arm Group Labels	Other Names
remifentanil	Drug	remifentanil infusion	1
remifentanil

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Postoperative opioid (oxycodone) consumption		Postoperatively 48 hours

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Coronary artery bypass grafting patients

Exclusion Criteria:

Psychiatric disorders, sleep apnea, cardiac insufficiency

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 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
Pasi Lahtinen, MD	Department of Anesthesiology and Intensive Care, Kuopio University hospital, Kuopio, Finland	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kuopio University hospital		Kuopio		70210	Finland

Condition Browse Module

MeSH Terms

ID	Term
D010146	Pain

Ancestor Terms

ID	Term
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

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided