Pharmacokinetic and -Dynamic of Propofol During Awake Craniotomy

Brain Tumor Clinical Trial

Official title:

Investigation on the Pharmacokinetic and -Dynamic of Propofol During Awake Craniotomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01128465
• Other study ID #: AC
• Status: Completed
• Phase: N/A
• First received: February 22, 2010
• Last updated: March 16, 2011
• Start date: February 2010

Study information

• Verified date: March 2011
• Source: University Hospital, Bonn
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial Summary

Certain kind of neurosurgical procedures require intraoperative alertness of the patient, for example to perform speech tests during brain tumor resection. With respect to anaesthesia, it is therefore required that the patient is asleep during the beginning and the end of the procedure, however fully awake in between. To do so, the anaesthetic propofol is used and an accurate knowledge of its pharmacokinetic and -dynamic (pk/pd) parameters is required to optimally control anaesthesia. However, diverse pk/pd-parameter sets have been described in the literature.

The aim of the study is to investigate whether the pk/pd model proposed by Marsh et al. or by Schnider et al. more accurately describe the pk/pd of propofol during awake craniotomy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patients scheduled for awake craniotomy

Exclusion Criteria:

• pregnancy

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Brain Neoplasms
• Brain Tumor

Locations

Country	Name	City	State
Germany	Dept. of Anaesthesiology and Intensive Care Medicine, Univ. of Bonn	Bonn

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bonn

Country where clinical trial is conducted

Germany, 

References & Publications (2)

Marsh B, White M, Morton N, Kenny GN. Pharmacokinetic model driven infusion of propofol in children. Br J Anaesth. 1991 Jul;67(1):41-8. — View Citation

Schnider TW, Minto CF, Gambus PL, Andresen C, Goodale DB, Shafer SL, Youngs EJ. The influence of method of administration and covariates on the pharmacokinetics of propofol in adult volunteers. Anesthesiology. 1998 May;88(5):1170-82. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	prediction error for propofol plasma concentrations	On the day of surgery, plasma samples will be drawn during induction, maintenance and recovery from anesthesia. Subsequently the actually measured propofol plasma concentration will be compared with the predicted propofol plasma concentration (according to Marsh et al. and Schnider et al.), and the prediction error will be calculated.	day of surgery (day 1)	No