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

The influence of epidural blockade with ropivacaine on the pharmacokinetics and pharmacodynamics of propofol sedation - Epidural ropivacaine and the pharmacokinetics / -dynamics of propofol

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON34206
Enrollment
28
Registered
2010-07-26
Start date
2010-12-15
Completion date
Unknown
Last updated
2024-05-06

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

Conditions

patienten die een epiduraal nodig hebben voor een operatie epidural analgesia

Interventions

There are 4 groups of 7 patients. The patients in group 1 will receive no ropivacaine (10 ml of epidural NaCl 0.9%), the patients in group 2 will receive 50 mg of epidural ropivacaine 7.5 mg/ml, the

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: •ASA class I-II •Age 18-65 years •Patients scheduled for surgery requiring epidural anaesthesia and sedation.

Exclusion criteria

Exclusion criteria: •Patients with a BMI >30. •Participation in a trial on investigational drugs within 3 months prior to the study. •Known history of hepatic, renal disease or other disease as judged by the investigators. •Bleeding or coagulation disorders Patients receiving chronic analgesic therapy. •Patients using β-blockers •Pregnancy or lactation. •Alcohol or drug abuses or history of alcohol/drug abuses. •Documented or suspected soybean protein and/or drug allergy or amide type local anesthetic allergy

Design outcomes

Primary

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

Secondary

MeasureTime frame
hemodynamic parameters

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)