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Effect of Anesthetics on Microcirculation in Patients Undergoing Off-pump Coronary Artery Bypass Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03209193
Recruitment Status : Completed
First Posted : July 6, 2017
Last Update Posted : March 4, 2020
Sponsor:
Information provided by (Responsible Party):
Youn Joung Cho, MD, Seoul National University Hospital

Brief Summary:
Volatile anesthetics, such as sevoflurane and desflurane, are commonly used in patients undergoing cardiac surgeries including off-pump coronary artery bypass. However, the effect of volatile anesthetics on microcirculation in patients undergoing off-pump coronary artery bypass has not been well conducted.

Condition or disease Intervention/treatment Phase
Microcirculation Anesthetic Complication Spinal Drug: Sevoflurane Drug: Desflurane Phase 4

Detailed Description:
This is a prospective randomized clinical trial investigating the effect of sevoflurane vs. desflurane on tissue microcirculation in patients undergoing off-pump coronary artery bypass surgery. Eligible patients are going to be randomized to receive sevoflurane or desflurane, as a maintenance anesthetic, during the surgery. Tissue oxygen saturation and microcirculatory changes, such as an occlusion and recovery slope, during vascular occlusion test will be recorded during the surgery. The primary end point of the study is the difference in tissue oxygen saturation between the groups.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Anesthetics on Microcirculation in Patients Undergoing Off-pump Coronary Artery Bypass Surgery
Actual Study Start Date : July 4, 2017
Actual Primary Completion Date : November 7, 2019
Actual Study Completion Date : November 7, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Sevoflurane
Sevoflurane (2 vol%) use as a maintenance volatile anesthetic drug during the surgery
Drug: Sevoflurane
Sevoflurane use as main anesthetic drug during the surgery

Experimental: Desflurane
Desflurane (6 vol%) use as a maintenance volatile anesthetic drug during the surgery
Drug: Desflurane
Desflurane use as main anesthetic drug during the surgery




Primary Outcome Measures :
  1. Tissue oxygen saturation measured at thenar eminence by Hutchinson(R) tissue oximeter during off-pump coronary artery bypass surgery [ Time Frame: Before induction of anesthesia to the end of the surgery, an average 8 hours ]
    Tissue oxygen saturation measured at thenar eminence by tissue oximeter during surgery in patients receiving sevoflurane or desflurane



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • scheduled for off-pump coronary artery bypass surgery

Exclusion Criteria:

  • any deformity or vascular abnormalities on upper arms
  • cannot receive sevoflurane or desflurane for any reason (muscular diseases, etc)
  • uncontrolled diabetes
  • peripheral vascular disease
  • severe renal dysfunction (end-stage renal disease)
  • refuse to enroll
  • pregnant

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03209193


Locations
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Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 03080
Sponsors and Collaborators
Seoul National University Hospital
Investigators
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Principal Investigator: Youn Joung Cho, MD Seoul National University Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Youn Joung Cho, MD, Clinical Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT03209193    
Other Study ID Numbers: OPCAB_SEVO vs DES
First Posted: July 6, 2017    Key Record Dates
Last Update Posted: March 4, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Youn Joung Cho, MD, Seoul National University Hospital:
off-pump coronary artery bypass
sevoflurane
desflurane
tissue oxygen saturation
Additional relevant MeSH terms:
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Sevoflurane
Desflurane
Platelet Aggregation Inhibitors
Anesthetics, Inhalation
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs