Pain therapy after elective cardiac surgery MedDRA version: 14.0 Level: LLT Classification code 10036236 Term: Postoperative pain relief System Organ Class: 10042613 - Surgical and medical procedures
Conditions
Interventions
Trade Name: Sufenta 50µg/ml Injektionslösung
Pharmaceutical Form: Solution for injection
INN or Proposed INN: SUFENTANIL CITRATE
CAS Number: 60561-17-3
Concentration unit: µg/ml microgram(s)/millilitr
Sponsors
Universitätsklinikum Erlangen
Eligibility
Sex/Gender
All
Inclusion 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 40 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: Use of MAO inhibitors in the last 14 days Chronic alcoholism or drug addiction in medical history Severe obstuctive or restrictive pulmonal disorders in medical history Severe hepatic and renal disorders in medical history Hypothyroidism, prostate hyperplasia, pancreatitis, biliary or renal colic in medical history ASA IV Pregnant or nursing females
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Pharmacokinetic-pharmacodynamic modeling for the interaction of sufentanil (administered during surgery via target-controlled infusion) and hydromorphone (administered after surgery as patient-controlled analgesia via target-controlled infusion) in the early postoperative period;Secondary Objective: • Description and comparison of antinociception caused by sufentanil and hydromorphone in the early postoperative period through indicators assessed in both treatment arms • Description and comparison of safety and tolerability of postoperative pain treatment with hydromorphone TCI, TCI-PCA and PCA after intraoperative sufentanil TCI in both treatment arms • Identification of the minimal hydromorphone target plasma concentration appropriate for postoperative pain treatment;Primary end point(s): • Course and comparison of the course of the Numerical Rating Scale-11 scores over time between the two treatment arms • Plasma concentrations of sufentanil and hydromorphone at predefined timepoints for both treatment arms;Timepoint(s) of evaluation of this end point: Visits 2 and 3 (Day 1 and 2/3) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Amount of sufentanil administered during sufentanil TCI for both treatment arm • Amount of hydromorphone administered during hydromorphone TCI, TCI-PCA and PCA for both treatment arms • Comparison of concentrations of sufentanil and hydromorphone at half-maximal effect EC50 between treatment arms • Pharmacokinetics of sufentanil and hydromorphone for both treatment arms • Frequency and incidence of AEs and SAEs in both treatment groups • MOAA/S at predefined timepoints in both treatment arms;Timepoint(s) of evaluation of this end point: Visits 2, 3 and 4 (Day 1, 2/3 and 3/4) | — |
Countries
Germany
Contacts
Public ContactAnästhesiologische Klinik
Universitätsklinikum Erlangen
Outcome results
None listed