Gender and PK-PD of Propofol and Cisatracurium
- Registration Number
- NCT02588118
- Lead Sponsor
- Medical University of Graz
- Brief Summary
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.
- 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 Serial arterial blood samples (5 ml) were withdrawn in EDTA-tubes before cisatracurium administration, 1, 3, 5, 7, 10, 13, 16, 19, 22, 25, 30, 60 and 90 min following administration.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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 120
- either males or females
- Liver disease
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description male group Cisatracurium 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. female group propofol 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. male group propofol 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. female group Cisatracurium 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.
- Primary Outcome Measures
Name Time Method propofol elimination half life 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.
- Secondary Outcome Measures
Name Time Method cisatracurium elimination half life 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.
Trial Locations
- Locations (2)
Xijing hospital of Fourth Military Medical University
🇨🇳Xi'an, Shaanxi, China
Medical University of Graz
🇦🇹Graz, Austria