Clinical trial NCT02609087: Effect on Cerebral Oxygenation by Sevoflurane or Propofol Using Near-infrared Spectroscopy in Carotid Endarterectomy
Official title: Comparison the Effect on Cerebral Oxygenation by Sevoflurane-remifentanil or Propofol-remifentanil Anesthesia Using Near-infrared Spectroscopy in Patients Undergoing Carotid Endarterectomy)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Carotid Stenosis
Lead sponsor: Chonnam National University Hospital
Sponsor class: OTHER
First posted: 2015-11-20
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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

Eligibility criteria: 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

Primary outcomes:
measure: cerebral oxygenation measured by near-infrared spectroscopy
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University Hospital
Study officials:
affiliation: Chonnam National University Hospital
name: Seongtae Jeong
role: PRINCIPAL_INVESTIGATOR
References:
citation: Park S, Yook K, Yoo KY, Choi JI, Bae HB, You Y, Jin B, Jeong S. Comparison of the effect of sevoflurane or propofol anesthesia on the regional cerebral oxygen saturation in patients undergoing carotid endarterectomy: a prospective, randomized controlled study. BMC Anesthesiol. 2019 Aug 17;19(1):157. doi: 10.1186/s12871-019-0820-9.