Pain Therapy After Elective Cardiac Surgery

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01490268

Acronym

PKPDHM-001

Enrollment

Registered

2011-12-12

Start date

2011-11-30

Completion date

2012-09-30

Last updated

2014-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain

Keywords

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

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.

Interventions

DRUGSufentanil, Hydromorphone

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

30 Years to 80 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Plasma concentrations of sufentanil and hydromorphone	48 hours	28 blood samples are taken during the study period of 48 hours postoperatively for characterizing the pharmacokinetics
Numerical Rating Scale for Clinical Pain	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

Measure	Time frame	Description
Total amount of hydromorphone	8 hours	Cumulative dose of hydromorphone for patient-controlled analgesia with target-controlled infusion of hydromorphone for characterizing the analgesic requirement
Modified Observer's Assessment of Alertness/Sedation (MOAA/S) Scale	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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 20, 2026