Gender and PK-PD of Propofol and Cisatracurium
Condition: Gender
Study type: Observational

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      samples (5 ml) were withdrawn in EDTA-tubes before cisatracurium administration, 1, 3, 5, 7,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.
    

Intervention name(s): propofol; Cisatracurium
Intervention type(s): Drug; Drug
Intervention description(s): 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 intervention name(s): diprivan; nimbix
Intervention MeSH terms: Propofol; Cisatracurium
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        differences between equal numbers of males and females