Comparison of Effect of Equi-MAC Anesthetics on PSI | NCT03587779

Studies
Comparison of Effect of Equi-MAC Anesthetics on PSI

NCT03587779

Sponsor

Kangbuk Samsung Hospital

Status

Completed

Last Update Posted

Sep 3, 2020Actual

Enrollment

74Actual

Phase

Not Applicable

Conditions

Anesthesia

Interventions

Sevoflurane
Desflurane

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 24, 2018Actual

Primary Completion Date

Jan 22, 2019Actual

Completion Date

Jan 22, 2019Actual

First Submitted Date

Jul 3, 2018

First Submission Date that Met QC Criteria

Jul 3, 2018

First Posted Date

Jul 16, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 2, 2020

Last Update Posted Date

Sep 3, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

There have been several studies comparing electroencephalogram-derived indices produced by sevoflurane and desflurane. However, to the best of our knowledge, there has been no study which compared the two inhaled anesthetics using patient state index. Therefore, the aim of this study is to compare the patient state index values produced by sevoflurane and desflurane at equi-MAC in patients undergoing single-agent inhalation anesthesia.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

74Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Sevoflurane	Experimental	Anesthesia is maintained with sevoflurane.	Drug: Sevoflurane
Desflurane	Experimental	Anesthesia is maintained with desflurane.	Drug: Desflurane

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Sevoflurane	Drug	Throughout the study period, anesthesia is maintained with sevoflurane of age-corrected equivalent minimum alveolar concentration.	Sevoflurane

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kyoung-Ho Ryu, M.D.	Kangbuk Samsung Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kangbuk Samsung Hospital		Seoul		03181	South Korea

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077149	Sevoflurane
D000077335	Desflurane

Ancestor Terms

ID	Term
D008738	Methyl Ethers
D004987	Ethers
D009930	Organic Chemicals
D006845	Hydrocarbons, Fluorinated

Browse Leaves

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Browse Branches

Not provided