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Pain Therapy After Elective Cardiac Surgery (PKPDHM-001)

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ClinicalTrials.gov Identifier: NCT01490268
Recruitment Status : Completed
First Posted : December 12, 2011
Last Update Posted : December 8, 2014
Sponsor:
Collaborator:
German Federal Ministry of Education and Research
Information provided by (Responsible Party):
University of Erlangen-Nürnberg Medical School

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.

Condition or disease Intervention/treatment Phase
Pain Drug: Sufentanil, Hydromorphone Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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
Study Start Date : November 2011
Actual Primary Completion Date : September 2012
Actual Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Plasma concentrations of sufentanil and hydromorphone [ Time Frame: 48 hours ]
    28 blood samples are taken during the study period of 48 hours postoperatively for characterizing the pharmacokinetics

  2. Numerical Rating Scale for Clinical Pain [ Time Frame: 8 hours ]
    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 :
  1. Total amount of hydromorphone [ Time Frame: 8 hours ]
    Cumulative dose of hydromorphone for patient-controlled analgesia with target-controlled infusion of hydromorphone for characterizing the analgesic requirement

  2. Modified Observer's Assessment of Alertness/Sedation (MOAA/S) Scale [ Time Frame: 8 hours ]
    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



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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications:
Responsible Party: University of Erlangen-Nürnberg Medical School
ClinicalTrials.gov Identifier: NCT01490268     History of Changes
Other Study ID Numbers: PKPDHM-001
2011-003648-31 ( EudraCT Number )
First Posted: December 12, 2011    Key Record Dates
Last Update Posted: December 8, 2014
Last Verified: December 2014

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:
Sufentanil
Hydromorphone
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics