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Pain Therapy After Elective Cardiac Surgery

Information source: University of Erlangen-Nürnberg Medical School
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pain

Intervention: Sufentanil, Hydromorphone (Drug); Sufentanil, Hydromorphone (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: University of Erlangen-Nürnberg Medical School

Official(s) and/or principal investigator(s):
Christian Jeleazcov, MD, Principal Investigator, Affiliation: Department of Anesthesiology, University Hospital Erlangen, Germany

Overall contact:
Christian Jeleazcov, MD, Phone: +49 9131 8542363, Email: christian.jeleazcov@kfa.imed.uni-erlangen.de

Summary

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.

Clinical Details

Official title: Pharmacokinetic-pharmacodynamic Modeling of the Postoperative Pain Sensation During Patient-controlled Analgesia With Target-controlled Infusion of Hydromorphone, Taking Into Account the Interaction With Intraoperatively Administered Sufentanil for Elective Cardiac Surgery

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Primary outcome:

Plasma concentrations of sufentanil and hydromorphone

Numerical Rating Scale for Clinical Pain

Secondary outcome:

Total amount of hydromorphone

Modified Observer's Assessment of Alertness/Sedation (MOAA/S) Scale

Eligibility

Minimum age: 30 Years. Maximum age: 80 Years. Gender(s): Both.

Criteria:

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

Locations and Contacts

Christian Jeleazcov, MD, Phone: +49 9131 8542363, Email: christian.jeleazcov@kfa.imed.uni-erlangen.de

Department of Anesthesiology, University Hospital, Erlangen, Germany; Recruiting
Christian Jeleazcov, MD, Phone: +49 9131 8542363, Email: christian.jeleazcov@kfa.imed.uni-erlangen.de
Jörg Fechner, MD, Phone: +49 9131 8542371, Email: joerg.fechner@kfa.imed.uni-erlangen.de
Christian Jeleazcov, MD, Principal Investigator
Jörg Fechner, MD, Sub-Investigator
Ljubica Krajinovic, MD, Sub-Investigator
Teijo Saari, MD, PhD, Sub-Investigator
Additional Information

Starting date: November 2011
Last updated: December 8, 2011

Page last updated: February 07, 2013

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