Clinical trial NCT01490268: Pain Therapy After Elective Cardiac Surgery
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain
Keywords: Pharmacokinetic-pharmacodynamic modeling
Patient-controlled analgesia
Target-controlled infusion
Hydromorphone
Sufentanil
after thoracotomy
cardiac surgery
Lead sponsor: University of Erlangen-Nürnberg Medical School
Sponsor class: OTHER
Collaborators: name: German Federal Ministry of Education and Research
First posted: 2011-12-12
Enrollment: 50
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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

Primary outcomes:
measure: Plasma concentrations of sufentanil and hydromorphone
timeFrame: 48 hours
measure: Numerical Rating Scale for Clinical Pain
timeFrame: 8 hours
Secondary outcomes:
measure: Total amount of hydromorphone
timeFrame: 8 hours
measure: Modified Observer's Assessment of Alertness/Sedation (MOAA/S) Scale
timeFrame: 8 hours
Other outcomes:
Locations:
city: Erlangen
country: Germany
facility: Department of Anesthesiology, University Hospital
Study officials:
affiliation: Department of Anesthesiology, University Hospital Erlangen, Germany
name: Christian Jeleazcov, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.