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

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ClinicalTrials.gov Identifier: NCT02609087
Recruitment Status : Completed
First Posted : November 20, 2015
Last Update Posted : January 11, 2017
Sponsor:
Information provided by (Responsible Party):
Seongtae Jeong, Chonnam National University Hospital

Tracking Information
First Submitted Date  ICMJE November 17, 2015
First Posted Date  ICMJE November 20, 2015
Last Update Posted Date January 11, 2017
Study Start Date  ICMJE August 2015
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 17, 2015)
cerebral oxygenation measured by near-infrared spectroscopy [ Time Frame: one year ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02609087 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect on Cerebral Oxygenation by Sevoflurane or Propofol Using Near-infrared Spectroscopy in Carotid Endarterectomy
Official Title  ICMJE Comparison the Effect on Cerebral Oxygenation by Sevoflurane-remifentanil or Propofol-remifentanil Anesthesia Using Near-infrared Spectroscopy in Patients Undergoing Carotid Endarterectomy)
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Carotid Stenosis
Intervention  ICMJE
  • Drug: Sevoflurane
  • Drug: Propofol
Study Arms  ICMJE
  • Experimental: 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
    Intervention: Drug: Sevoflurane
  • Experimental: 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
    Intervention: Drug: Propofol
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 9, 2017)
69
Original Estimated Enrollment  ICMJE
 (submitted: November 17, 2015)
54
Actual Study Completion Date  ICMJE December 2016
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02609087
Other Study ID Numbers  ICMJE CNUH-2015-159
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Seongtae Jeong, Chonnam National University Hospital
Study Sponsor  ICMJE Chonnam National University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Seongtae Jeong Chonnam National University Hospital
PRS Account Chonnam National University Hospital
Verification Date January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP