Pain Therapy After Elective Cardiac Surgery (PKPDHM-001)

December 5, 2014 updated by: University of Erlangen-Nürnberg Medical School

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Erlangen, Germany
        • Department of Anesthesiology, University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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
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 2
Sufentanil High Titration
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
48 hours
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
8 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
8 hours
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
8 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Erlangen-Nürnberg Medical School

Collaborators

German Federal Ministry of Education and Research

Investigators

  • Principal Investigator: Christian Jeleazcov, MD, Department of Anesthesiology, University Hospital Erlangen, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2011

Primary Completion (Actual)

September 1, 2012

Study Completion (Actual)

September 1, 2012

Study Registration Dates

First Submitted

November 28, 2011

First Submitted That Met QC Criteria

December 8, 2011

First Posted (Estimate)

December 12, 2011

Study Record Updates

Last Update Posted (Estimate)

December 8, 2014

Last Update Submitted That Met QC Criteria

December 5, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PKPDHM-001
  • 2011-003648-31 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pain

Clinical Trials on Sufentanil, Hydromorphone

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Australia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe