Gender and PK-PD of Propofol and Cisatracurium

NCT02588118 | Completed

• 1 other identifier: MUGraz5
• Study Type: observational
• Target: 120
• Locations: 2 countries
• Sites: 2

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.

Conditions

Gender

Outcome Measures

Primary Outcomes (1)

• propofol elimination half life

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 Serial arterial blood samples (5 ml) were withdrawn in EDTA-tubes before cisatracurium administration, 1, 3, 5, 7, 10, 13, 16, 19, 22, 25, 30, 60 and 90 min following administration.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

• cisatracurium elimination half life

  before administration till 120 minutes

Study Arms (2)

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 Serial arterial blood samples (5 ml) were withdrawn in EDTA-tubes before cisatracurium administration, 1, 3, 5, 7, 10, 13, 16, 19, 22, 25, 30, 60 and 90 min following administration.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

Drug: propofol; Drug: Cisatracurium

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 Serial arterial blood samples (5 ml) were withdrawn in EDTA-tubes before cisatracurium administration, 1, 3, 5, 7, 10, 13, 16, 19, 22, 25, 30, 60 and 90 min following administration.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

Drug: propofol; Drug: Cisatracurium

Interventions

propofol DRUG

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.

Also known as: diprivan

female group; male group

Cisatracurium DRUG

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.

Also known as: nimbix

female group; male group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

differences between equal numbers of males and females

You may qualify if:

• \. either males or females

You may not qualify if:

• \. Liver disease

Sponsors & Collaborators

• Medical University of Graz: lead

Study Sites (2)

Medical University of Graz

Graz, 8046, Austria

Location

Xijing hospital of Fourth Military Medical University

Xi'an, Shaanxi, China

Location

Related Publications (2)

• 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.

  PMID: 9034227 BACKGROUND

• 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.

  PMID: 11573657 BACKGROUND

MeSH Terms

Conditions

Coitus

Interventions

Propofol; cisatracurium

Condition Hierarchy (Ancestors)

Sexual Behavior; Behavior

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Ashraf Dahaba

  Medical University of Graz

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: October 23, 2015
• First Posted: October 27, 2015
• Study Start: January 1, 2010
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: August 12, 2019

Record last verified: 2019-08

Locations

CN (1); AU (1)