- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02588118
Gender and PK-PD of Propofol and Cisatracurium (BIS5)
Effect of Gender on the Pharmacokinetics-pharmacodynamics of Propofol and Cisatracurium Besylate
Study Overview
Detailed Description
Background: In recent years it has become clear that gender differences exist both in the pharmacokinetics and the pharmacodynamics of drugs related to the practice of anesthesia. Differences in pharmacokinetics are more straightforward to study than differences in clinical effects. However, isolated pharmacokinetic data are of less value if they are not accompanied by measurements of clinical effects. Males are more sensitive than females to propofol. It may therefore be necessary to decrease the propofol dose by 30-40% in males. Females have 20-30% greater sensitivity to the muscle relaxant effects.
Methods: Anaesthesia is induced with propofol 2 mg/kg (t0) followed by cisatracurium 0.1 mg/kg 1 min from propofol administration (t2). Patients will be monitored using the conventionally available bispectral index monitoring for propofol concentrations and Relaxometer mechanomyograph neuromuscular monitoring for cisatracurium. Serial arterial blood samples (5 ml) were withdrawn in EDTA-tubes before cisatracurium administration, 1, 3, 5, 7, 10, 13, 16, 19, 22, 25, 30, 60 and 90 min following administration. Blood samples were assayed in duplicate using high performance liquid chromatograph. Pharmacokinetic analysis was performed by fitting the cisatracurium blood concentration time profile of individual patients, to non-compartmental as well as multi-compartmental pharmacokinetic models.
Study Type
Enrollment (Actual)
Contacts and Locations
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
1. either males or females
Exclusion Criteria:
1. Liver disease
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
male group
Propofol 2 mg/kg (t0) followed by cisatracurium 0.1 mg/kg 1 min (t2).
Patients will be monitored using bispectral index monitoring for propofol and Relaxometer mechanomyograph neuromuscular monitoring for cisatracurium.
Serial arterial blood samples (5 ml) were withdrawn in EDTA-tubes before cisatracurium administration, 1, 3, 5, 7, 10, 13, 16, 19, 22, 25, 30, 60 and 90 min following administration.
Blood samples were assayed in duplicate using high performance liquid chromatograph for Pharmacokinetic analysis.
|
Propofol 2 mg/kg (t0) followed by cisatracurium 0.1 mg/kg 1 min (t2).
Patients will be monitored using bispectral index monitoring for propofol and Relaxometer mechanomyograph neuromuscular monitoring for cisatracurium.
Serial arterial blood samples (5 ml) were withdrawn in EDTA-tubes before cisatracurium administration, 1, 3, 5, 7, 10, 13, 16, 19, 22, 25, 30, 60 and 90 min following administration.
Blood samples were assayed in duplicate using high performance liquid chromatograph for Pharmacokinetic analysis.
Other Names:
Propofol 2 mg/kg (t0) followed by cisatracurium 0.1 mg/kg 1 min (t2).
Patients will be monitored using bispectral index monitoring for propofol and Relaxometer mechanomyograph neuromuscular monitoring for cisatracurium.
Serial arterial blood samples (5 ml) were withdrawn in EDTA-tubes before cisatracurium administration, 1, 3, 5, 7, 10, 13, 16, 19, 22, 25, 30, 60 and 90 min following administration.
Blood samples were assayed in duplicate using high performance liquid chromatograph for Pharmacokinetic analysis.
Other Names:
|
female group
Propofol 2 mg/kg (t0) followed by cisatracurium 0.1 mg/kg 1 min (t2).
Patients will be monitored using bispectral index monitoring for propofol and Relaxometer mechanomyograph neuromuscular monitoring for cisatracurium.
Serial arterial blood samples (5 ml) were withdrawn in EDTA-tubes before cisatracurium administration, 1, 3, 5, 7, 10, 13, 16, 19, 22, 25, 30, 60 and 90 min following administration.
Blood samples were assayed in duplicate using high performance liquid chromatograph for Pharmacokinetic analysis.
|
Propofol 2 mg/kg (t0) followed by cisatracurium 0.1 mg/kg 1 min (t2).
Patients will be monitored using bispectral index monitoring for propofol and Relaxometer mechanomyograph neuromuscular monitoring for cisatracurium.
Serial arterial blood samples (5 ml) were withdrawn in EDTA-tubes before cisatracurium administration, 1, 3, 5, 7, 10, 13, 16, 19, 22, 25, 30, 60 and 90 min following administration.
Blood samples were assayed in duplicate using high performance liquid chromatograph for Pharmacokinetic analysis.
Other Names:
Propofol 2 mg/kg (t0) followed by cisatracurium 0.1 mg/kg 1 min (t2).
Patients will be monitored using bispectral index monitoring for propofol and Relaxometer mechanomyograph neuromuscular monitoring for cisatracurium.
Serial arterial blood samples (5 ml) were withdrawn in EDTA-tubes before cisatracurium administration, 1, 3, 5, 7, 10, 13, 16, 19, 22, 25, 30, 60 and 90 min following administration.
Blood samples were assayed in duplicate using high performance liquid chromatograph for Pharmacokinetic analysis.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
propofol elimination half life
Time Frame: before administration till 120 minutes
|
Propofol 3 mg/kg (t0) followed by cisatracurium 0.1 mg/kg 2 min (t2).
Patients will be monitored using bispectral index monitoring for propofol.
Serial arterial blood samples (5 ml) were withdrawn in EDTA-tubes before cisatracurium administration, 1, 3, 5, 7, 10, 13, 16, 19, 22, 25, 30, 60 and 90 min following administration.
Blood samples were assayed in duplicate using high performance liquid chromatograph for Pharmacokinetic analysis.
|
before administration till 120 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
cisatracurium elimination half life
Time Frame: before administration till 120 minutes
|
Propofol 3 mg/kg (t0) followed by cisatracurium 0.1 mg/kg 2 min (t2).
Patients will be monitored using TOF-Watch neuromuscular monitoring for cisatracurium.
Serial arterial blood samples (5 ml) were withdrawn in EDTA-tubes before cisatracurium administration, 1, 3, 5, 7, 10, 13, 16, 19, 22, 25, 30, 60 and 90 min following administration.
Blood samples were assayed in duplicate using high performance liquid chromatograph for Pharmacokinetic analysis.
|
before administration till 120 minutes
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ashraf Dahaba, Medical University of Graz
Publications and helpful links
General Publications
- Schmith VD, Fiedler-Kelly J, Phillips L, Grasela TH Jr. Prospective use of population pharmacokinetics/pharmacodynamics in the development of cisatracurium. Pharm Res. 1997 Jan;14(1):91-7. doi: 10.1023/a:1012015719694.
- Vuyk J, Oostwouder CJ, Vletter AA, Burm AG, Bovill JG. Gender differences in the pharmacokinetics of propofol in elderly patients during and after continuous infusion. Br J Anaesth. 2001 Feb;86(2):183-8. doi: 10.1093/bja/86.2.183.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MUGraz5
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