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 hydromorphoneNumerical Rating Scale for Clinical Pain
Secondary outcome: Total amount of hydromorphoneModified 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
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