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Pain Therapy After Elective Cardiac Surgery

Information source: University of Erlangen-Nürnberg Medical School
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pain

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

Phase: Phase 4

Status: Completed

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


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


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


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,


- Pregnant or nursing females

Locations and Contacts

Department of Anesthesiology, University Hospital, Erlangen, Germany
Additional Information

Related publications:

Jeleazcov C, Saari TI, Ihmsen H, Mell J, Fröhlich K, Krajinovic L, Fechner J, Schüttler 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.

Saari TI, Ihmsen H, Mell J, Fröhlich K, Fechner J, Schüttler 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.

Saari TI, Fechner J, Ihmsen H, Schüttler 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.

Saari TI, Fechner J, Ihmsen H, Schüttler 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.

Starting date: November 2011
Last updated: December 5, 2014

Page last updated: August 23, 2015

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