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

Carotid Stenosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02609087
• Other study ID #: CNUH-2015-159
• Status: Completed
• Phase: Phase 4
• First received: November 17, 2015
• Last updated: January 9, 2017
• Start date: August 2015
• Est. completion date: December 2016

Study information

• Verified date: January 2017
• Source: Chonnam National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carotid Stenosis

Intervention

Drug:
• Sevoflurane

• Propofol

Locations

Country	Name	City	State
Korea, Republic of	Chonnam National University Hospital	Gwangju

Sponsors (1)

Lead Sponsor	Collaborator
Chonnam National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cerebral oxygenation measured by near-infrared spectroscopy		one year	No