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
  Purpose

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.


Condition Intervention Phase
Pain
Drug: Sufentanil, Hydromorphone
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by University of Erlangen-Nürnberg Medical School:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Enrollment: 50
Study Start Date: November 2011
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Sufentanil Group 1
Sufentanil Low Titration
Drug: Sufentanil, Hydromorphone
Intraoperatively: Target controlled infusion with 0.4 ng/ml Sufentanil, Postoperatively: Patient-controlled analgesia with target-controlled infusion of Hydromorphone
Active Comparator: Sufentanil Group 2
Sufentanil High Titration
Drug: Sufentanil, Hydromorphone
Intraoperatively: Target controlled infusion with 0.8 ng/ml Sufentanil, Postoperatively: Patient-controlled analgesia with target-controlled infusion of Hydromorphone

  Eligibility

Ages Eligible for Study:   30 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01490268

Locations
Germany
Department of Anesthesiology, University Hospital
Erlangen, Germany
Sponsors and Collaborators
University of Erlangen-Nürnberg Medical School
German Federal Ministry of Education and Research
Investigators
Principal Investigator: Christian Jeleazcov, MD Department of Anesthesiology, University Hospital Erlangen, Germany
  More Information

No publications provided by University of Erlangen-Nürnberg Medical School

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Erlangen-Nürnberg Medical School
ClinicalTrials.gov Identifier: NCT01490268     History of Changes
Other Study ID Numbers: PKPDHM-001, 2011-003648-31
Study First Received: November 28, 2011
Last Updated: February 26, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University of Erlangen-Nürnberg Medical School:
Pharmacokinetic-pharmacodynamic modeling
Patient-controlled analgesia
Target-controlled infusion
Hydromorphone
Sufentanil
after thoracotomy
cardiac surgery

Additional relevant MeSH terms:
Hydromorphone
Sufentanil
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics

ClinicalTrials.gov processed this record on September 16, 2014