Comparison of Effect of Equi-MAC Anesthetics on PSI

September 2, 2020 updated by: Kyoung-Ho Ryu, MD, Kangbuk Samsung Hospital

Comparison of the Effect of Sevoflurane and Desflurane on Patient State Index: A Randomized Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

74

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sevoflurane
Anesthesia is maintained with sevoflurane.
Drug: Sevoflurane
Throughout the study period, anesthesia is maintained with sevoflurane of age-corrected equivalent minimum alveolar concentration.
Other Names:
  • Sevorane
Experimental: Desflurane
Anesthesia is maintained with desflurane.
Drug: Desflurane
Throughout the study period, anesthesia is maintained with desflurane of age-corrected equivalent minimum alveolar concentration.
Other Names:
  • Suprane

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
patient state index
Time Frame: After a 30-min waiting period from the induction of anesthesia
patient state index value at a steady-state anesthesia of equi-MAC
After a 30-min waiting period from the induction of anesthesia

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kangbuk Samsung Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 24, 2018

Primary Completion (Actual)

January 22, 2019

Study Completion (Actual)

January 22, 2019

Study Registration Dates

First Submitted

July 3, 2018

First Submitted That Met QC Criteria

July 3, 2018

First Posted (Actual)

July 16, 2018

Study Record Updates

Last Update Posted (Actual)

September 3, 2020

Last Update Submitted That Met QC Criteria

September 2, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018-05-045

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Anesthesia

Clinical Trials on Sevoflurane

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Philippines

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe