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NCT Number: NCT02609087

Effect on Cerebral Oxygenation by Sevoflurane or Propofol Using Near-infrared Spectroscopy in Carotid Endarterectomy

The aim of this study is comparing the effect on cerebral oxygenation by sevoflurane-remifentanil or propofol-remifentanil anesthesia in patient undergoing carotid endarterectomy. Cerebral oxygenation is measured by near-infrared spectroscopy. Sevoflurane and propofol reduce the cerebral metabolic rate for oxygen in similar degree. Propofol decrease the cerebral blood flow by dose-dependent manner, however, sevoflurane increase the cerebral blood flow in the concentration of avobe 1 MAC. Both drugs are widely used in general anesthesia for neurosurgical procedure, and their effect on cerebral oxygenation are acceptable. There is little data about the effect of general anethetics on cerebral oxygenation in patients undergoing carotid endarterectomy, who have imparied cerebral circulation. Our hypothesis is sevoflurane will show better cerebral oxygenation than propofol in patient have impaired cerebral circulation.

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Key information

Conditions

Carotid Stenosis Arterial Occlusive Diseases Brain Diseases Cardiovascular Diseases Carotid Artery Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Chonnam National University Hospital

Gwangju, 505-757, South Korea

About this study

This study is performed by monitoring the cerebral oxygenation using near-infrared spectroscopy from general anesthesia induction to 10 min after releasing the carotid artery clipping.

Study group: Sevoflurane - remifentanil anesthesia group (S) Propofol - remifentanil anesthesia group (R)

Monitoring: near-infrared spectroscopy (SOMA sensor) BIS, HR, arterial blood pressure, SpO2, body temperature

Patient seletion

  • inclusion criteria
  • American Society of Anesthesiologist (ASA) physical status 1-3
  • 18 ~ 70 years
  • patient who agree with informed concent
  • exclusion criteria
  • ASA physical status > 4
  • preoperative SpO2 < 97%
  • patient who has other neurologic disease not related to carotid endarterectomy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • American Society of Anesthesiologist (ASA) physical status 1-3
  • 18 ~ 70 years
  • patient who agree with informed consent

Exclusion criteria

  • ASA physical status > 4
  • preoperative SpO2 < 97%
  • patient who has other neurologic disease not related to carotid endarterectomy

Treatment and study plan

Sevoflurane

Drug

Propofol

Drug

Primary outcomes

  1. cerebral oxygenation measured by near-infrared spectroscopy

    Time frame: one year

Sponsors and collaborators

Lead sponsor

Chonnam National University Hospital

Other

Registry information

Official study title

Comparison the Effect on Cerebral Oxygenation by Sevoflurane-remifentanil or Propofol-remifentanil Anesthesia Using Near-infrared Spectroscopy in Patients Undergoing Carotid Endarterectomy)

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Nov 20, 2015
Registry last updated
Jan 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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