The Effect of Different End-tidal Carbon-dioxide Levels on Cerebral CO2 Vasoreactivity and the Stiffness of Systemic Arteries During Propofol Anesthesia

NCT02203097 | Completed Phase 4 DMC

• 2 other identifiers: 030167-006/2014/OTIG2345
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Propofol-anaesthesia Via Target-controlled Infusion

Keywords

Target controlled infusion; propofol; cerebral vasoreactivity; arterial stiffness; Transcranial Doppler; SphygmoCor

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• 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

Other Outcomes (1)

• Changes in subendocardial viability ratio (SEVR)

  Changes form baseline in SEVR at the 15th, 20th and 25th minutes of the operation

Study Arms (1)

Propofol

EXPERIMENTAL

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.

Procedure: Partial pressure of CO2 at the end of an exhaled breath; Drug: Propofol

Interventions

Partial pressure of CO2 at the end of an exhaled breath PROCEDURE

Three previously defined EtCO2 levels (partial pressure of CO2 at the end of an exhaled breath) were adjusted during anesthesia.

Also known as: EtCO2

Propofol

Propofol DRUG

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.

Also known as: Diprivan

Propofol

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Above the age 18
• American Society of Anesthesiologists (ASA) physical classification I. or II.
• Patients undergoing elective varicotomy, inguinal hernioplasty or breast surgery in general anesthesia

You may not qualify if:

• Patients with cerebral, cardiac or systemic vascular disorders (hypertension, diabetes)
• Patients receiving medication that affects the blood vessels (antihypertensive, antidiabetic, antiarrhythmic medications)

Sponsors & Collaborators

• University of Debrecen: lead

Study Sites (1)

University of Debrecen Medical and Health Science Center Department of Anesthesiology and Intensive Care

Debrecen, 4032, Hungary

Location

Related Publications (7)

• 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.

  PMID: 10616858 RESULT

• 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.

  PMID: 17197845 RESULT

• 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.

  PMID: 21547779 RESULT

• 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.

  PMID: 8160985 RESULT

• 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.

  PMID: 12603451 RESULT

• 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.

  PMID: 15630765 RESULT

• 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.

  PMID: 33901551 DERIVED

MeSH Terms

Interventions

Propofol

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant lecturer anesthesiologist and intensive care specialist

Study Record Dates

• First Submitted: July 25, 2014
• First Posted: July 29, 2014
• Study Start: January 1, 2014
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: March 9, 2017

Record last verified: 2017-03

Locations

HU (1)