Comparison of Effect of Equi-MAC Anesthetics on PSI

Sponsor

Kangbuk Samsung Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT03587779

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

12.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Anesthesia	Drug: Sevoflurane Drug: Desflurane	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

74 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Jul 24, 2018

Actual Primary Completion Date :

Jan 22, 2019

Actual Study Completion Date :

Jan 22, 2019

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

patient state index [After a 30-min waiting period from the induction of anesthesia]
patient state index value at a steady-state anesthesia of equi-MAC

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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