Epidural blockade affects the pharmacokinetics of propofol in surgical patients

The influence of epidural blockade with ropivacaine on the pharmacokinetics and pharmacodynamics of propofol sedation in patients

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN14865526

Enrollment

Registered

2014-01-30

Start date

2010-12-13

Completion date

Unknown

Last updated

2015-01-13

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

Conditions

The effect of epidural analgesia with ropivacaine on the pharmacokinetics and pharmacodynamics of propofol in patients Surgery

Interventions

28 patients were randomly assigned to one of four study groups. After written informed consent the patients received an intravenous cannula, a lumbar epidural catheter at L2-L3, placed 5 cm in the e

it took 30-40 minutes to achieve a steady block level. Thereafter patients received a target controlled infusion with propofol with an initial target concentration of 1 µg/ml. After 6, 12 and 18 min t

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. American Society of Anesthesiologists (ASA) class I-II 2. Age 18-65 years 3. Patients scheduled for surgery requiring epidural anaesthesia and sedation

Exclusion criteria

Exclusion criteria: 1. Patients with a body mass index (BMI) >30 2. Participation in a trial on investigational drugs within 3 months prior to the study 3. Known history of hepatic, renal disease or other disease as judged by the investigators 4. Bleeding or coagulation disorders 5. Patients receiving chronic analgesic therapy 6. Patients using alpha-blockers 7. Pregnancy or lactation 8. Alcohol or drug abuse or history of alcohol/drug abuse 9. Documented or suspected soybean protein and/or drug allergy 10. Allergy for amide-type local anesthetics

Design outcomes

Primary

Measure	Time frame
To evaluate the influence of epidural blockade with ropivacaine on the pharmacokinetics of propofol. Assessments of the epidural blockade level will be performed every 5 min during the first 30 min until a stable level of analgesia is established. A stable level is defined as an unchanged upper blockade level during two consecutive assessments. The level of sensory loss is determined by loss of cold sensation bilateral in the anterior axillary line and by the pin prick test. Motor function loss is tested using the Bromage scale. Every 3rd min, the Ramsay sedation score, the eyelash reflex, the BIS score and state of consciousness will be tested and an arterial blood sample will be taken for blood propofol concentration determination. The state of consciousness is tested by asking the patient to perform a simple task after gently tapping at the shoulder ('open your eyes please'). Unconsciousness will be defined as no response to this command. Samples (5 ml) for the determination of the plasma propofol concentrations will be taken 3, 6, 9, 12, 15 and 18 min after the start of the target controlled propofol infusion and 2, 5, 10, 20, 30, 60, 90 and 120 min after termination of the propofol infusion. Samples for the ropivacaine concentration will be taken 5, 10, 15, 30, 60, 90 and 120 minutes after the epidural loading dose.	—

Measure

Time frame

To evaluate the influence of epidural blockade with ropivacaine on the pharmacokinetics of propofol. Assessments of the epidural blockade level will be performed every 5 min during the first 30 min until a stable level of analgesia is established. A stable level is defined as an unchanged upper blockade level during two consecutive assessments. The level of sensory loss is determined by loss of cold sensation bilateral in the anterior axillary line and by the pin prick test. Motor function loss is tested using the Bromage scale. Every 3rd min, the Ramsay sedation score, the eyelash reflex, the BIS score and state of consciousness will be tested and an arterial blood sample will be taken for blood propofol concentration determination. The state of consciousness is tested by asking the patient to perform a simple task after gently tapping at the shoulder ('open your eyes please'). Unconsciousness will be defined as no response to this command. Samples (5 ml) for the determination of the plasma propofol concentrations will be taken 3, 6, 9, 12, 15 and 18 min after the start of the target controlled propofol infusion and 2, 5, 10, 20, 30, 60, 90 and 120 min after termination of the propofol infusion. Samples for the ropivacaine concentration will be taken 5, 10, 15, 30, 60, 90 and 120 minutes after the epidural loading dose.

—

Secondary

Measure	Time frame
To evaluate the influence of epidural blockade with ropivacaine on the pharmacodynamics of propofol. This includes both the sedative and the hemodynamic effects.	—

Countries

Netherlands

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026