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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03209193
Other study ID # OPCAB_SEVO vs DES
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date July 4, 2017
Est. completion date November 7, 2019

Study information

Verified date March 2020
Source Seoul National University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 72
Est. completion date November 7, 2019
Est. primary completion date November 7, 2019
Accepts healthy volunteers No
Gender All
Age group 20 Years to 90 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Sevoflurane
Sevoflurane use as main anesthetic drug during the surgery
Desflurane
Desflurane use as main anesthetic drug during the surgery

Locations

Country Name City State
Korea, Republic of Seoul National University Hospital Seoul

Sponsors (1)

Lead Sponsor Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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