Effect of Anesthetics on Microcirculation in Patients Undergoing Off-pump Coronary Artery Bypass Surgery
1 other identifier
interventional
72
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Jul 2017
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 3, 2017
CompletedStudy Start
First participant enrolled
July 4, 2017
CompletedFirst Posted
Study publicly available on registry
July 6, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 7, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
November 7, 2019
CompletedMarch 4, 2020
March 1, 2020
2.3 years
July 3, 2017
March 3, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Tissue oxygen saturation measured at thenar eminence by Hutchinson(R) tissue oximeter during off-pump coronary artery bypass surgery
Tissue oxygen saturation measured at thenar eminence by tissue oximeter during surgery in patients receiving sevoflurane or desflurane
Before induction of anesthesia to the end of the surgery, an average 8 hours
Study Arms (2)
Sevoflurane
EXPERIMENTALSevoflurane (2 vol%) use as a maintenance volatile anesthetic drug during the surgery
Desflurane
EXPERIMENTALDesflurane (6 vol%) use as a maintenance volatile anesthetic drug during the surgery
Interventions
Eligibility Criteria
You may qualify if:
- scheduled for off-pump coronary artery bypass surgery
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seoul National University Hospital
Seoul, 03080, South Korea
Related Publications (1)
Cho YJ, Yoo SJ, Nam K, Bae JY, Lee SH, Jeon Y. Effects of anesthetics on microvascular reactivity measured by vascular occlusion tests during off-pump coronary artery bypass surgery: a randomized controlled trial. J Clin Monit Comput. 2021 Oct;35(5):1219-1228. doi: 10.1007/s10877-020-00587-8. Epub 2020 Sep 11.
PMID: 32915370DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Youn Joung Cho, MD
Seoul National University Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Professor
Study Record Dates
First Submitted
July 3, 2017
First Posted
July 6, 2017
Study Start
July 4, 2017
Primary Completion
November 7, 2019
Study Completion
November 7, 2019
Last Updated
March 4, 2020
Record last verified: 2020-03