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

NCT ID: NCT00757198

Last Updated: 2013-09-12

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

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2011-12-31

Brief Summary

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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

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Conditions

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Pain

Keywords

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pain, postoperative, opioid, PCA, cardiac surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

remifentanil o.1 mcg/kg/min

Group Type EXPERIMENTAL

remifentanil

Intervention Type DRUG

remifentanil infusion

2

remifentanil 0.3 mcg/kg/min

Group Type ACTIVE_COMPARATOR

remifentanil

Intervention Type DRUG

remifentanil infusion

Interventions

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remifentanil

remifentanil infusion

Intervention Type DRUG

remifentanil

remifentanil infusion

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Coronary artery bypass grafting patients

Exclusion Criteria

* Psychiatric disorders, sleep apnea, cardiac insufficiency
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kuopio University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Pasi Lahtinen

PhD,MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Pasi Lahtinen, MD

Role: STUDY_DIRECTOR

Department of Anesthesiology and Intensive Care, Kuopio University hospital, Kuopio, Finland

Locations

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Kuopio University hospital

Kuopio, , Finland

Site Status

Countries

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Finland

Other Identifiers

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EudraCT 2008-000597-21

Identifier Type: -

Identifier Source: secondary_id

KUH5070206

Identifier Type: -

Identifier Source: org_study_id