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

Sponsor

Seoul National University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT03209193

Collaborator

(none)

Enrollment

Location

Arms

28.1

Actual Duration (Months)

2.6

Patients Per Site Per Month

Study Details

Study Description

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.

Study Design

Study Type:

Interventional

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 :

Jul 4, 2017

Actual Primary Completion Date :

Nov 7, 2019

Actual Study Completion Date :

Nov 7, 2019

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Tissue oxygen saturation measured at thenar eminence by Hutchinson(R) tissue oximeter during off-pump coronary artery bypass surgery [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seoul National University Hospital	Seoul		Korea, Republic of	03080

Sponsors and Collaborators

Seoul National University Hospital

Investigators

Principal Investigator: Youn Joung Cho, MD, Seoul National University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

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:

Jul 6, 2017

Last Update Posted:

Mar 4, 2020

Last Verified:

Mar 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Youn Joung Cho, MD, Clinical Professor, Seoul National University Hospital

off-pump coronary artery bypass

sevoflurane

desflurane

tissue oxygen saturation

Additional relevant MeSH terms:

Sevoflurane

Desflurane

Study Results

No Results Posted as of Mar 4, 2020