NCT03587779

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
74

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 3, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 16, 2018

Completed
8 days until next milestone

Study Start

First participant enrolled

July 24, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 22, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 22, 2019

Completed
Last Updated

September 3, 2020

Status Verified

September 1, 2020

Enrollment Period

6 months

First QC Date

July 3, 2018

Last Update Submit

September 2, 2020

Conditions

Anesthesia

Keywords

patient state indexsevofluranedesfluraneminimum alveolar concentration

Outcome Measures

Primary Outcomes (1)

  • patient state index

    patient state index value at a steady-state anesthesia of equi-MAC

    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

SevofluraneDRUG

Throughout the study period, anesthesia is maintained with sevoflurane of age-corrected equivalent minimum alveolar concentration.

Also known as: Sevorane
Sevoflurane
DesfluraneDRUG

Throughout the study period, anesthesia is maintained with desflurane of age-corrected equivalent minimum alveolar concentration.

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 surgery under volatile anesthesia
  • patients obtaining written informed consent

You may not qualify if:

  • patients with a history of any psychiatric or neurological disease
  • patients receiving any medication affecting the autonomic or central nervous system
  • patients with a history of alcohol or drug abuse
  • pregnant or lactating women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kangbuk Samsung Hospital

Seoul, 03181, South Korea

Location

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

July 3, 2018

First Posted

July 16, 2018

Study Start

July 24, 2018

Primary Completion

January 22, 2019

Study Completion

January 22, 2019

Last Updated

September 3, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)