NCT03570164

Brief Summary

The aim of this study is to compare the peripheral perfusion index values produced by equi-MAC of sevoflurane and desflurane in patients undergoing single-agent inhalation anesthesia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2018

Shorter than P25 for not_applicable

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

June 15, 2018

Completed
3 days until next milestone

Study Start

First participant enrolled

June 18, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 26, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 13, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 13, 2018

Completed
Last Updated

October 21, 2019

Status Verified

October 1, 2019

Enrollment Period

5 months

First QC Date

June 15, 2018

Last Update Submit

October 18, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • peripheral perfusion index

    peripheral perfusion index value at a steady-state anesthesia of age-corrected 1.0 MAC

    After a 30-min waiting period from the induction of anesthesia

Secondary Outcomes (2)

  • mean arterial pressure

    After a 30-min waiting period from the induction of anesthesia

  • heart rate

    After a 30-min waiting period from the induction of anesthesia

Study Arms (2)

Sevoflurane

EXPERIMENTAL

Anesthesia is maintained with sevoflurane.

Drug: Sevoflurane

Desflurane

EXPERIMENTAL

Anesthesia is maintained with desflurane.

Drug: Desflurane

Interventions

End-tidal concentration of sevoflurane is maintained at age-corrected 1.0 minimum alveolar concentration throughout the study period.

Also known as: Sevorane
Sevoflurane

End-tidal concentration of desflurane is maintained at age-corrected 1.0 minimum alveolar concentration throughout the study period.

Also known as: Suprane
Desflurane

Eligibility Criteria

Age19 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients aged between 19 and 65 yr
  • patients with American Society of Anesthesiologists physical status classification I or II
  • patients scheduled for elective arthroscopic knee surgery under general anesthesia
  • patients obtaining written informed consent

You may not qualify if:

  • patients with a history of any disease associated with the autonomic nervous system
  • patients receiving any medication affecting the sympathetic or parasympathetic nervous systems
  • patients with cardiac arrhythmia, diabetes mellitus, and alcohol or drug abuse
  • pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kangbuk Samsung Hospital

Seoul, 03181, South Korea

Location

Related Publications (1)

  • Ryu KH, Hwang SH, Shim JG, Ahn JH, Cho EA, Lee SH, Byun JH. Comparison of vasodilatory properties between desflurane and sevoflurane using perfusion index: a randomised controlled trial. Br J Anaesth. 2020 Dec;125(6):935-942. doi: 10.1016/j.bja.2020.07.050. Epub 2020 Sep 18.

MeSH Terms

Interventions

SevofluraneDesflurane

Intervention Hierarchy (Ancestors)

Methyl EthersEthersOrganic ChemicalsHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbonsEthyl Ethers

Study Officials

  • Kyoung-Ho Ryu, M.D.

    Kangbuk Samsung Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

June 15, 2018

First Posted

June 26, 2018

Study Start

June 18, 2018

Primary Completion

November 13, 2018

Study Completion

November 13, 2018

Last Updated

October 21, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations