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

NCT ID: NCT02609087

Last Updated: 2017-01-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 69 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-08-31
• Study Completion Date: 2016-12-31

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

Conditions

Carotid Stenosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Sevoflurane

adjust the end-tidal sevoflurane (sevofran inhaler, Hana pharmacy, Korea) concentration maintaining the 40 \~ 50 BIS (bispectral index) with 3 ng/ml of remifentanil using TCI (target controlled infusion) pump

Group Type: EXPERIMENTAL

Sevoflurane

Intervention Type: DRUG

Propofol

adjust propofol (FRESOFOL MCT INJ 2% (vial), Fresinus Kabi Korea) concentration maintaining the 40 \~ 50 BIS (bispectral index) with 3 ng/ml of remifentanil using TCI (target controlled infusion) pump

Group Type: EXPERIMENTAL

Propofol

Intervention Type: DRUG

Interventions

Sevoflurane

Intervention Type: DRUG

Propofol

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chonnam National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Seongtae Jeong

Associated professor, Anesthesiolgoy and Pain Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Seongtae Jeong

Role: PRINCIPAL_INVESTIGATOR

Chonnam National University Hospital

Locations

Chonnam National University Hospital

Gwangju, , South Korea

Countries

South Korea

References

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.

Reference Type: DERIVED

PMID: 31421685 (View on PubMed)

Other Identifiers

CNUH-2015-159

Identifier Type: -

Identifier Source: org_study_id