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Pain Therapy After Elective Cardiac Surgery

NCT ID: NCT01490268

Last Updated: 2014-12-08

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

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2012-09-30

Brief Summary

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The purpose of this study is to determine generation of a target controlled infusion model for the patient controlled analgesia with the strong analgesic, hydromorphone, after planned open heart surgery, during which the strong analgesic, sufentanil, was used.

Detailed Description

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Conditions

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Pain

Keywords

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Pharmacokinetic-pharmacodynamic modeling Patient-controlled analgesia Target-controlled infusion Hydromorphone Sufentanil after thoracotomy cardiac surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Sufentanil Group 1

Sufentanil Low Titration

Group Type ACTIVE_COMPARATOR

Sufentanil, Hydromorphone

Intervention Type DRUG

Intraoperatively: Target controlled infusion with 0.4 ng/ml Sufentanil, Postoperatively: Patient-controlled analgesia with target-controlled infusion of Hydromorphone

Sufentanil Group 2

Sufentanil High Titration

Group Type ACTIVE_COMPARATOR

Sufentanil, Hydromorphone

Intervention Type DRUG

Intraoperatively: Target controlled infusion with 0.8 ng/ml Sufentanil, Postoperatively: Patient-controlled analgesia with target-controlled infusion of Hydromorphone

Interventions

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Sufentanil, Hydromorphone

Intraoperatively: Target controlled infusion with 0.4 ng/ml Sufentanil, Postoperatively: Patient-controlled analgesia with target-controlled infusion of Hydromorphone

Intervention Type DRUG

Sufentanil, Hydromorphone

Intraoperatively: Target controlled infusion with 0.8 ng/ml Sufentanil, Postoperatively: Patient-controlled analgesia with target-controlled infusion of Hydromorphone

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Written informed consent,
* Ability to understand the nature of patient-controlled analgesia and other study-specific procedures,
* Elective cardiac surgery with thoracotomy and subsequent stay in the intensive care unit

Exclusion Criteria

* Use of MAO inhibitors in the last 14 days,
* Chronic alcoholism or drug addiction in medical history,
* Severe obstructive or restrictive pulmonal disorders in medical history,
* Severe hepatic and renal disorders in medical history,
* Hypothyroidism, pancreatitis in medical history,
* ASA IV,
* Pregnant or nursing females
Minimum Eligible Age

30 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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German Federal Ministry of Education and Research

OTHER_GOV

Sponsor Role collaborator

University of Erlangen-Nürnberg Medical School

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Christian Jeleazcov, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Anesthesiology, University Hospital Erlangen, Germany

Locations

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Department of Anesthesiology, University Hospital

Erlangen, , Germany

Site Status

Countries

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Germany

References

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Jeleazcov C, Saari TI, Ihmsen H, Mell J, Frohlich K, Krajinovic L, Fechner J, Schuttler J. Population pharmacokinetic modeling of hydromorphone in cardiac surgery patients during postoperative pain therapy. Anesthesiology. 2014 Feb;120(2):378-91. doi: 10.1097/ALN.0b013e3182a76d05.

Reference Type BACKGROUND
PMID: 23958818 (View on PubMed)

Saari TI, Ihmsen H, Mell J, Frohlich K, Fechner J, Schuttler J, Jeleazcov C. Influence of intensive care treatment on the protein binding of sufentanil and hydromorphone during pain therapy in postoperative cardiac surgery patients. Br J Anaesth. 2014 Oct;113(4):677-87. doi: 10.1093/bja/aeu160. Epub 2014 Jul 6.

Reference Type BACKGROUND
PMID: 25001621 (View on PubMed)

Saari TI, Fechner J, Ihmsen H, Schuttler J, Jeleazcov C. Analysis of total and unbound hydromorphone in human plasma by ultrafiltration and LC-MS/MS: application to clinical trial in patients undergoing open heart surgery. J Pharm Biomed Anal. 2012 Dec;71:63-70. doi: 10.1016/j.jpba.2012.07.025. Epub 2012 Jul 31.

Reference Type BACKGROUND
PMID: 22884788 (View on PubMed)

Saari TI, Fechner J, Ihmsen H, Schuttler J, Jeleazcov C. Determination of total and unbound sufentanil in human plasma by ultrafiltration and LC-MS/MS: application to clinical pharmacokinetic study. J Pharm Biomed Anal. 2012 Jul;66:306-13. doi: 10.1016/j.jpba.2012.03.050. Epub 2012 Apr 3.

Reference Type BACKGROUND
PMID: 22522038 (View on PubMed)

Other Identifiers

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2011-003648-31

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

PKPDHM-001

Identifier Type: -

Identifier Source: org_study_id