Pain Therapy After Elective Cardiac Surgery

NCT01490268 | Completed Phase 4

• 2 other identifiers: PKPDHM-0012011-003648-31
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain

Keywords

Pharmacokinetic-pharmacodynamic modeling; Patient-controlled analgesia; Target-controlled infusion; Hydromorphone; Sufentanil; after thoracotomy; cardiac surgery

Outcome Measures

Primary Outcomes (2)

• Plasma concentrations of sufentanil and hydromorphone

  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

  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 Outcomes (2)

• Total amount of hydromorphone

  8 hours

• Modified Observer's Assessment of Alertness/Sedation (MOAA/S) Scale

  8 hours

Study Arms (2)

Sufentanil Group 1

ACTIVE COMPARATOR

Sufentanil Low Titration

Drug: Sufentanil, Hydromorphone

Sufentanil Group 2

ACTIVE COMPARATOR

Sufentanil High Titration

Drug: Sufentanil, Hydromorphone

Interventions

Sufentanil, Hydromorphone DRUG

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

Sufentanil Group 1

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Erlangen-Nürnberg Medical School: lead
• German Federal Ministry of Education and Research: collaborator

Study Sites (1)

Department of Anesthesiology, University Hospital

Erlangen, Germany

Location

Related Publications (4)

• Jeleazcov C, Saari TI, Ihmsen H, Mell J, Frohlich K, Krajinovic L, Fechner J, Schuttler J. Population pharmacokinetic modeling of hydromorphone in cardiac surgery patients during postoperative pain therapy. Anesthesiology. 2014 Feb;120(2):378-91. doi: 10.1097/ALN.0b013e3182a76d05.

  PMID: 23958818 BACKGROUND

• Saari TI, Ihmsen H, Mell J, Frohlich K, Fechner J, Schuttler J, Jeleazcov C. Influence of intensive care treatment on the protein binding of sufentanil and hydromorphone during pain therapy in postoperative cardiac surgery patients. Br J Anaesth. 2014 Oct;113(4):677-87. doi: 10.1093/bja/aeu160. Epub 2014 Jul 6.

  PMID: 25001621 BACKGROUND

• Saari TI, Fechner J, Ihmsen H, Schuttler 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.

  PMID: 22884788 BACKGROUND

• Saari TI, Fechner J, Ihmsen H, Schuttler J, Jeleazcov C. Determination of total and unbound sufentanil in human plasma by ultrafiltration and LC-MS/MS: application to clinical pharmacokinetic study. J Pharm Biomed Anal. 2012 Jul;66:306-13. doi: 10.1016/j.jpba.2012.03.050. Epub 2012 Apr 3.

  PMID: 22522038 BACKGROUND

MeSH Terms

Conditions

Pain

Interventions

Sufentanil; Hydromorphone

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Fentanyl; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Christian Jeleazcov, MD

  Department of Anesthesiology, University Hospital Erlangen, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2011
• First Posted: December 12, 2011
• Study Start: November 1, 2011
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: December 8, 2014

Record last verified: 2014-12

Locations

DE (1)