Pain Therapy After Elective Cardiac Surgery

University of Erlangen-Nürnberg Medical School50 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Pain

Interventions

Sufentanil, HydromorphoneDRUG

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

Sufentanil, HydromorphoneDRUG

Intraoperatively: Target controlled infusion with 0.8 ng/ml Sufentanil, Postoperatively: Patient-controlled analgesia with target-controlled infusion of Hydromorphone

Eligibility

Sex: ALLMin age: 30 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Department of Anesthesiology, University Hospital

Erlangen, Germany

Outcomes

Primary Outcomes

Plasma concentrations of sufentanil and hydromorphone

28 blood samples are taken during the study period of 48 hours postoperatively for characterizing the pharmacokinetics

Time frame: 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

Time frame: 8 hours

Secondary Outcomes

Total amount of hydromorphone

Cumulative dose of hydromorphone for patient-controlled analgesia with target-controlled infusion of hydromorphone for characterizing the analgesic requirement

Time frame: 8 hours

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

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

Time frame: 8 hours

Data from ClinicalTrials.gov

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