Pain Therapy After Elective Cardiac Surgery (PKPDHM-001)

This study has been completed.
Sponsor:
Collaborator:
German Federal Ministry of Education and Research
Information provided by (Responsible Party):
University of Erlangen-Nürnberg Medical School
ClinicalTrials.gov Identifier:
NCT01490268
First received: November 28, 2011
Last updated: February 26, 2013
Last verified: February 2013

November 28, 2011
February 26, 2013
November 2011
September 2012   (final data collection date for primary outcome measure)
  • Plasma concentrations of sufentanil and hydromorphone [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
    28 blood samples are taken during the study period of 48 hours postoperatively for characterizing the pharmacokinetics
  • Numerical Rating Scale for Clinical Pain [ Time Frame: 8 hours ] [ Designated as safety issue: Yes ]
    11 assessments of patient's pain sensation using Numerical Rating Scale for Clinical Pain during patient-controlled analgesia with target-controlled infusion of hydromorphone 8 hours after extubation for characterizing the analgesic effect
Same as current
Complete list of historical versions of study NCT01490268 on ClinicalTrials.gov Archive Site
  • Total amount of hydromorphone [ Time Frame: 8 hours ] [ Designated as safety issue: No ]
    Cumulative dose of hydromorphone for patient-controlled analgesia with target-controlled infusion of hydromorphone for characterizing the analgesic requirement
  • Modified Observer's Assessment of Alertness/Sedation (MOAA/S) Scale [ Time Frame: 8 hours ] [ Designated as safety issue: Yes ]
    11 assessments of the Modified Observer's Assessment of Alertness/Sedation (MOAA/S) Scale during patient-controlled analgesia with target-controlled infusion of hydromorphone 8 hours after extubation for characterizing the sedation level
  • Total amount of hydromorphone [ Time Frame: 8 hours ] [ Designated as safety issue: No ]
    Cumulative dose of hydromorphone for patient-controlled analgesia with target-controlled infusion of hydromorphone for characterizing the analgesic requirement
  • Modified Observer's Assessment of Alertness/Sedation (MOAA/S) Scale [ Time Frame: 8 hours ] [ Designated as safety issue: Yes ]
    11 assessements of the Modified Observer's Assessment of Alertness/Sedation (MOAA/S) Scale during patient-controlled analgesia with target-controlled infusion of hydromorphone 8 hours after extubation for characterizing the sedation level
Not Provided
Not Provided
 
Pain Therapy After Elective Cardiac Surgery
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

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Pain
  • Drug: Sufentanil, Hydromorphone
    Intraoperatively: Target controlled infusion with 0.4 ng/ml Sufentanil, Postoperatively: Patient-controlled analgesia with target-controlled infusion of Hydromorphone
  • Drug: Sufentanil, Hydromorphone
    Intraoperatively: Target controlled infusion with 0.8 ng/ml Sufentanil, Postoperatively: Patient-controlled analgesia with target-controlled infusion of Hydromorphone
  • Active Comparator: Sufentanil Group 1
    Sufentanil Low Titration
    Intervention: Drug: Sufentanil, Hydromorphone
  • Active Comparator: Sufentanil Group 2
    Sufentanil High Titration
    Intervention: Drug: Sufentanil, Hydromorphone
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
September 2012
September 2012   (final data collection date for primary outcome measure)

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
Both
30 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01490268
PKPDHM-001, 2011-003648-31
No
University of Erlangen-Nürnberg Medical School
University of Erlangen-Nürnberg Medical School
German Federal Ministry of Education and Research
Principal Investigator: Christian Jeleazcov, MD Department of Anesthesiology, University Hospital Erlangen, Germany
University of Erlangen-Nürnberg Medical School
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP