NCT03209193

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jul 2017

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 3, 2017

Completed
1 day until next milestone

Study Start

First participant enrolled

July 4, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 6, 2017

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 7, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 7, 2019

Completed
Last Updated

March 4, 2020

Status Verified

March 1, 2020

Enrollment Period

2.3 years

First QC Date

July 3, 2017

Last Update Submit

March 3, 2020

Conditions

Keywords

off-pump coronary artery bypasssevofluranedesfluranetissue oxygen saturation

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

EXPERIMENTAL

Sevoflurane (2 vol%) use as a maintenance volatile anesthetic drug during the surgery

Drug: Sevoflurane

Desflurane

EXPERIMENTAL

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

Drug: Desflurane

Interventions

Sevoflurane use as main anesthetic drug during the surgery

Sevoflurane

Desflurane use as main anesthetic drug during the surgery

Desflurane

Eligibility Criteria

Age20 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

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.

MeSH Terms

Interventions

SevofluraneDesflurane

Intervention Hierarchy (Ancestors)

Methyl EthersEthersOrganic ChemicalsHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbonsEthyl Ethers

Study Officials

  • Youn Joung Cho, MD

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

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

Locations