Pharmacokinetic and -Dynamic of Propofol During Awake Craniotomy

NCT01128465 | Completed

• 1 other identifier: AC
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain Tumor

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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)

Eligibility Criteria

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

Study Population

Patients of a University Hospital requiring an awake craniotomy for resection of a brain tumor or lesion

You may qualify if:

• patients scheduled for awake craniotomy

You may not qualify if:

• pregnancy

Sponsors & Collaborators

• University Hospital, Bonn: lead

Study Sites (1)

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

Bonn, 53105, Germany

Location

Related Publications (3)

• 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.

  PMID: 9605675 BACKGROUND

• 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.

  PMID: 1859758 BACKGROUND

• 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.

  PMID: 25774459 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

plasma

MeSH Terms

Conditions

Brain Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Martin Soehle, MD, DESA, D habil

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 22, 2010
• First Posted: May 24, 2010
• Study Start: February 1, 2010
• Last Updated: March 17, 2011

Record last verified: 2011-03

Locations

DE (1)