Pain Therapy After Elective Cardiac Surgery (PKPDHM-001)

University of Erlangen-Nürnberg Medical School

Status and phase: Completed; Phase 4

Conditions: Pain

Treatments: Drug: Sufentanil, Hydromorphone

Study type: Interventional

Funder types: Other

Identifiers

NCT01490268

2011-003648-31 (EudraCT Number)

PKPDHM-001

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 30 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups

Sufentanil Group 1

Active Comparator group

Description:

Sufentanil Low Titration

Treatment:

Drug: Sufentanil, Hydromorphone

Drug: Sufentanil, Hydromorphone

Sufentanil Group 2

Active Comparator group

Description:

Sufentanil High Titration

Treatment:

Drug: Sufentanil, Hydromorphone

Drug: Sufentanil, Hydromorphone