The Effect of Sevoflurane on Cerebral CO2 Sensitivity and Systemic Arteries

NCT02054143 | Completed Phase 4 DMC

• 2 other identifiers: 17637-1/2012/EKUDEOEC RKEB/IKEB:3584-2012
• Study Type: interventional
• Target: 24
• 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 sevoflurane. Sevoflurane is a widely and commonly used inhalational anaesthetic, that is mainly used for the maintenance of general anesthesia.
• 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 sevoflurane 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: \- Sevoflurane alters cerebral carbon-dioxide sensitivity and the stiffness of systemic arteries.

Conditions

Sevoflurane Anesthesia

Keywords

sevoflurane; 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)

Sevoflurane

EXPERIMENTAL

Sevoflurane was administered to all patients at 1 minimal alveolar concentration (MAC) after the intubation occured until the patient was extubated.

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

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

Sevoflurane

Sevoflurane DRUG

Sevoflurane was administered to all patients at 1 minimal alveolar concentration (MAC) during the whole operation.

Also known as: Sevorane

Sevoflurane

Eligibility Criteria

• Age: 18 Years - 60 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 or inguinal hernioplasty 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 (1)

• Juhasz M, Molnar L, Fulesdi B, Vegh T, Pall D, Molnar C. Effect of sevoflurane on systemic and cerebral circulation, cerebral autoregulation and CO2 reactivity. BMC Anesthesiol. 2019 Jun 19;19(1):109. doi: 10.1186/s12871-019-0784-9.

  PMID: 31215448 DERIVED

MeSH Terms

Interventions

Sevoflurane

Intervention Hierarchy (Ancestors)

Methyl Ethers; Ethers; Organic Chemicals; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons

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: January 31, 2014
• First Posted: February 4, 2014
• Study Start: November 1, 2012
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: February 4, 2014

Record last verified: 2014-02

Locations

HU (1)