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
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.
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
Plasma concentrations of sufentanil and hydromorphone
Numerical Rating Scale for Clinical Pain
Total amount of hydromorphone
Modified Observer's Assessment of Alertness/Sedation (MOAA/S) Scale
Minimum age: 30 Years.
Maximum age: 80 Years.
- Written informed consent,
- Ability to understand the nature of patient-controlled analgesia and other
- Elective cardiac surgery with thoracotomy and subsequent stay in the intensive care
- 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
Department of Anesthesiology, University Hospital, Erlangen, Germany
Jeleazcov C, Saari TI, Ihmsen H, Mell J, FrÃ¶hlich K, Krajinovic L, Fechner J, SchÃ¼ttler 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, FrÃ¶hlich K, Fechner J, SchÃ¼ttler 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, SchÃ¼ttler 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, SchÃ¼ttler 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