NCT02203097|CompletedPhase 4DMC
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Sponsor study identifier
Secondary identifiers
OTHER · University of Debrecen, RKEB/IKEB
interventional
25
1 country
1
Study Start
January 2014
Actual (reported)Primary Completion
December 2016
Actual (reported)Study Completion
December 2016
Actual (reported)Purpose: The purpose of this study is to examine the effect of different carbon-dioxide concentrations on cerebral CO2 sensitivity and the resistance and stiffness of systemic arteries during anesthesia with target-controlled infusion anesthesia using intravenous propofol. Propofol is a widely and commonly used intravenous anaesthetic, that is mainly used for the induction of general anesthesia and the maintenance of total intravenous anaesthesia (TIVA). Changes in the velocity of cerebral blood flow and arterial stiffness due to the different exhaled carbon-dioxide concentrations will allow us to conclude how propofol affects these parameters during the course of the narcosis. Instruments: An ultrasound device called transcranial doppler (TCD) is used to measure the velocity of blood flow within a main artery located inside the skull. A tonometry device named SphygmoCor is used to assess the pressure wave proceeding in the radial artery, from which the stiffness of the systemic vessels can be concluded. Measurements: \- Examinations with the ultrasound and tonometry devices are carried out once before the operation, three times during the intervention, with different exhaled CO2 values and once after the operation is completed. Hypothesis: \- Propofol alters cerebral carbon-dioxide sensitivity and the stiffness of systemic arteries during TCI anaesthesia.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2016
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 2014
Actual (reported)July 25, 2014
Actual (reported)July 29, 2014
Actual (reported)December 2016
Actual (reported)December 2016
Actual (reported)Blood flow velocity in the middle cerebral artery
Systolic, diastolic and mean blood flow velocities are measured with transcranial doppler device.
Changes from baseline in blood flow velocity at the 15th, 20th and 25th minutes of the operation
Arterial wall stiffness of the radial artery
Changes from baseline in arterial stiffness at the 15th, 20th and 25th minutes of the operation
Changes in the central systolic and diastolic blood pressure
Changes from baseline in central blood pressure at the 15th, 20th and 25th minutes of the operation
Changes in subendocardial viability ratio (SEVR)
Changes form baseline in SEVR at the 15th, 20th and 25th minutes of the operation
Propofol is administered to all patients via target-controlled infusion (TCI) to reach 4 mcg/ml constant plasma concentration according to the Schneider model during the course of the narcosis.
Three previously defined EtCO2 levels (partial pressure of CO2 at the end of an exhaled breath) were adjusted during anesthesia.
Propofol is administered to all patients via target-controlled infusion (TCI) to reach 4 mcg/ml constant plasma concentration according to the Schneider model during the course of the narcosis.
University of Debrecen Medical and Health Science Center Department of Anesthesiology and Intensive Care
Debrecen, 4032, Hungary
Fulesdi B, Limburg M, Bereczki D, Kaplar M, Molnar C, Kappelmayer J, Neuwirth G, Csiba L. Cerebrovascular reactivity and reserve capacity in type II diabetes mellitus. J Diabetes Complications. 1999 Jul-Aug;13(4):191-9. doi: 10.1016/s1056-8727(99)00044-6.
McCulloch TJ, Thompson CL, Turner MJ. A randomized crossover comparison of the effects of propofol and sevoflurane on cerebral hemodynamics during carotid endarterectomy. Anesthesiology. 2007 Jan;106(1):56-64. doi: 10.1097/00000542-200701000-00012.
Csilla Molnár, MD, PhD
University of Debrecen Medical and Health Science Center Department of Anesthesiology and Intensive Care 4032-Debrecen, Nagyerdei krt 98. Hungary Tel/fax: +36-52-255-347
25 participants (actual enrollment reported by the registry).
First Submitted
July 25, 2014
First Posted
July 29, 2014
Study Start
January 2014
Actual (reported)Pharmacokinetic/Pharmacodynamic Model of Propofol in Children
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Lan YC, Shen CH, Kang HM, Chong FC. Pulse transit time reveals drug kinetics on vascular changes affected by propofol. Comput Methods Biomech Biomed Engin. 2012;15(9):949-52. doi: 10.1080/10255842.2011.567981. Epub 2011 May 24.
Strebel S, Kaufmann M, Guardiola PM, Schaefer HG. Cerebral vasomotor responsiveness to carbon dioxide is preserved during propofol and midazolam anesthesia in humans. Anesth Analg. 1994 May;78(5):884-8. doi: 10.1213/00000539-199405000-00009.
Holzer A, Winter W, Greher M, Reddy M, Stark J, Donner A, Zimpfer M, Illievich UM. A comparison of propofol and sevoflurane anaesthesia: effects on aortic blood flow velocity and middle cerebral artery blood flow velocity. Anaesthesia. 2003 Mar;58(3):217-22. doi: 10.1046/j.1365-2044.2003.03041.x.
Previgliano IJ. Assessment: transcranial Doppler ultrasonography: report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology. Neurology. 2004 Dec 28;63(12):2457-8; author reply 2457-8. No abstract available.
Juhasz M, Pall D, Fulesdi B, Molnar L, Vegh T, Molnar C. The effect of propofol-sufentanil intravenous anesthesia on systemic and cerebral circulation, cerebral autoregulation and CO2 reactivity: a case series. Braz J Anesthesiol. 2021 Sep-Oct;71(5):558-564. doi: 10.1016/j.bjane.2021.04.002. Epub 2021 Apr 23.
Primary Completion
December 2016
Actual (reported)Study Completion
December 2016
Actual (reported)Last Updated
March 9, 2017
Record last verified: 2017-03
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