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NCT03587779 Clinical Trial

Comparison of Effect of Equi-MAC Anesthetics on PSI

Anesthesia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03587779
Other study ID # 2018-05-045
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 24, 2018
Est. completion date January 22, 2019

Study information
Verified date September 2020
Source Kangbuk Samsung Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 74
Est. completion date January 22, 2019
Est. primary completion date January 22, 2019
Accepts healthy volunteers No
Gender All
Age group 19 Years to 65 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• Sevoflurane
Throughout the study period, anesthesia is maintained with sevoflurane of age-corrected equivalent minimum alveolar concentration.
• Desflurane
Throughout the study period, anesthesia is maintained with desflurane of age-corrected equivalent minimum alveolar concentration.

Locations
Country Name City State
Korea, Republic of Kangbuk Samsung Hospital Seoul

Sponsors (1)
Lead Sponsor Collaborator
Kangbuk Samsung Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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