Effect on Cerebral Oxygenation by Sevoflurane or Propofol Using Near-infrared Spectroscopy in Carotid Endarterectomy
Primary Purpose
Carotid Stenosis
Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Sevoflurane
Propofol
Sponsored by
About this trial
This is an interventional treatment trial for Carotid Stenosis
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
Sites / Locations
- Chonnam National University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Sevoflurane
Propofol
Arm Description
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
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
Outcomes
Primary Outcome Measures
cerebral oxygenation measured by near-infrared spectroscopy
Secondary Outcome Measures
Full Information
NCT ID
NCT02609087
First Posted
November 17, 2015
Last Updated
January 9, 2017
Sponsor
Chonnam National University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02609087
Brief Title
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
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
August 2015 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chonnam National University Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carotid Stenosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
69 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sevoflurane
Arm Type
Experimental
Arm Description
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
Arm Title
Propofol
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Sevoflurane
Intervention Type
Drug
Intervention Name(s)
Propofol
Primary Outcome Measure Information:
Title
cerebral oxygenation measured by near-infrared spectroscopy
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seongtae Jeong
Organizational Affiliation
Chonnam National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chonnam National University Hospital
City
Gwangju
ZIP/Postal Code
505-757
Country
Korea, Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
31421685
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.
Results Reference
derived
Learn more about this trial
Effect on Cerebral Oxygenation by Sevoflurane or Propofol Using Near-infrared Spectroscopy in Carotid Endarterectomy
We'll reach out to this number within 24 hrs