NCT00757198

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for phase_4 pain

Timeline
Completed

Started Sep 2008

Longer than P75 for phase_4 pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2008

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

September 22, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 23, 2008

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

September 12, 2013

Status Verified

September 1, 2013

Enrollment Period

3.2 years

First QC Date

September 22, 2008

Last Update Submit

September 11, 2013

Conditions

Pain

Keywords

pain, postoperative, opioid, PCA, cardiac surgery

Outcome Measures

Primary Outcomes (1)

  • Postoperative opioid (oxycodone) consumption

    Postoperatively 48 hours

Study Arms (2)

1

EXPERIMENTAL

remifentanil o.1 mcg/kg/min

Drug: remifentanil

2

ACTIVE COMPARATOR

remifentanil 0.3 mcg/kg/min

Drug: remifentanil

Interventions

remifentanilDRUG

remifentanil infusion

1

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Coronary artery bypass grafting patients

You may not qualify if:

  • Psychiatric disorders, sleep apnea, cardiac insufficiency

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kuopio University hospital

Kuopio, 70210, Finland

Location

MeSH Terms

Conditions

Pain

Interventions

Remifentanil

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PropionatesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Pasi Lahtinen, MD

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

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD,MD

Study Record Dates

First Submitted

September 22, 2008

First Posted

September 23, 2008

Study Start

September 1, 2008

Primary Completion

November 1, 2011

Study Completion

December 1, 2011

Last Updated

September 12, 2013

Record last verified: 2013-09

Locations

FI(1)