Pain Therapy After Elective Cardiac Surgery

Phase 4 Completed 50 enrolled University of Erlangen-Nürnberg Medical School German Federal Ministry of Education and Research · collab

RandomizedParallel-groupSingle-blindTreatment

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.

Timeline

Start: 2011-11
Primary completion: 2012-09
Completion: 2012-09

Publications

Background 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.
Background 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.
Background 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.
Background 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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Hydromorphone	Other / unclassified	—	Other
Comparator	Sufentanil	Other / unclassified	0.4 ng/ml	Other
Comparator	Sufentanil	Other / unclassified	0.8 ng/ml	Other

Indications

No indication recorded.