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Pharmacokinetic and -Dynamic of Propofol During Awake Craniotomy

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01128465
Enrollment
10
Registered
2010-05-24
Start date
2010-02-28
Completion date
Unknown
Last updated
2011-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain Tumor

Keywords

propofol, awake craniotomy, patients requiring an awake craniotomy for brain tumor/lesion resection

Brief 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.

Interventions

None listed

Sponsors

University Hospital, Bonn
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* patients scheduled for awake craniotomy

Exclusion criteria

* pregnancy

Design outcomes

Primary

MeasureTime frameDescription
prediction error for propofol plasma concentrationsday of surgery (day 1)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.

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026