CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 120 enrolled
Drug / intervention
propofol +1 moredrug
Likely dose
propofol 2 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02588118
NCT02588118N/ACompleted

Effect of Gender on the Pharmacokinetics-pharmacodynamics of Propofol and Cisatracurium Besylate

Medical University of Graz·observational·Posted Oct 27, 2015·Updated Aug 12, 2019

In Brief

An observational study evaluating propofol and Cisatracurium for Gender. Completed, enrolled 120 participants across 2 sites in 2 countries.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsGender
CountriesAustria, China
Collaborators--

Timeline

N/ACompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedOct 27, 2015
Enrollment StartJan 1, 2010
Primary CompletionApr 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 10.7 years ago

Interventions

propofoldrug

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 Serial arterial blood samples (5 ml) were withdrawn in EDTA-tubes before cisatracurium administration, 1, 3, 5, 7, 10, 13, 16, 19, 22, 25, 30, 60 and 90 min following administration.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.

Cisatracuriumdrug

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.