Pharmacokinetic and -Dynamic of Propofol During Awake Craniotomy

NCT ID: NCT01128465

Last Updated: 2011-03-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

10 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Brain Tumor

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* patients scheduled for awake craniotomy

Exclusion Criteria

* pregnancy
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Bonn

OTHER

Sponsor Role lead

Responsible Party

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Dept. of Anaesthesiology and Intensive Care Medicine

Principal Investigators

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Martin Soehle, MD, DESA, D habil

Role: PRINCIPAL_INVESTIGATOR

Dept. of Anaesthesiology and Intensive Care Medicine, University of Bonn, Germany

Locations

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Dept. of Anaesthesiology and Intensive Care Medicine, Univ. of Bonn

Bonn, , Germany

Site Status

Countries

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Germany

References

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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. doi: 10.1097/00000542-199805000-00006.

Reference Type BACKGROUND
PMID: 9605675 (View on PubMed)

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. doi: 10.1093/bja/67.1.41.

Reference Type BACKGROUND
PMID: 1859758 (View on PubMed)

Soehle M, Wolf CF, Priston MJ, Neuloh G, Bien CG, Hoeft A, Ellerkmann RK. Comparison of propofol pharmacokinetic and pharmacodynamic models for awake craniotomy: A prospective observational study. Eur J Anaesthesiol. 2015 Aug;32(8):527-34. doi: 10.1097/EJA.0000000000000255.

Reference Type DERIVED
PMID: 25774459 (View on PubMed)

Other Identifiers

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AC

Identifier Type: -

Identifier Source: org_study_id

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