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Completed

NCT Number: NCT01490268

Pain Therapy After 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.

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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

30 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Anesthesiology, University Hospital

Erlangen, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sufentanil, Hydromorphone

Drug

Intraoperatively: Target controlled infusion with 0.4 ng/ml Sufentanil, Postoperatively: Patient-controlled analgesia with target-controlled infusion of Hydromorphone

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Erlangen-Nürnberg Medical School

Other

Collaborators

  • German Federal Ministry of Education and Research

Registry information

Official study 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

Acronym: PKPDHM-001

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Dec 12, 2011
Registry last updated
Dec 8, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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