Recruitment

Recruitment Status
Unknown status
Estimated Enrollment
Same as current

Summary

Conditions
General Anesthesia
Type
Interventional
Phase
Not Applicable
Design
Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Diagnostic

Participation Requirements

Age
Between 18 years and 80 years
Gender
Both males and females

Description

A hundred patients with the American Society of Anesthesiologists (ASA) physical status I-II, aged from 18 to 80 years, gave an informed-written consent to participate.Testing took place in the morning after an overnight fast. Patients were scheduled for elective surgical procedures. After arrival t...

A hundred patients with the American Society of Anesthesiologists (ASA) physical status I-II, aged from 18 to 80 years, gave an informed-written consent to participate.Testing took place in the morning after an overnight fast. Patients were scheduled for elective surgical procedures. After arrival to the operating theater, the peripheral venous line for fluid and drug administration was inserted. The electrocardiogram, heart rate, a noninvasive blood pressure, a pulse oximeter and bispectral (BIS) Index were monitored continuously. 100% oxygen was given for 3 min by face mask. Anesthesia was induced by intravenous infusion of propofol via the syringe pump at a rate of 30 mg/kg/h. Recordings began before propofol induction started. After the start of the propofol infusion and BIS Index at 80, patients were asked loudly "open eyes" and examined eyelash reflex at 15-s intervals until loss of consciousness (unresponsiveness to the verbal command, no spontaneous movements and loss of eyelash reflex); and recordings of the heart rate, a noninvasive blood pressure and BIS Index were obtained during awake baseline and unconsciousness induced by propofol. Propofol dosage and consciousness disappearance time were recorded after propofol-induced loss of consciousness. The commands were spoken in a loud voice by the investigator and were repeated up to three times, if the subject failed to respond. A subject who obeyed command was considered conscious. The BIS index is useful, and a reliable and sensitive indicator for assessing the level of consciousness during sedation and hypnosis with propofol so that the investigators recorded BIS index to evaluate level of consciousness. To minimize artifacts, patients were instructed not to open their eyes, talk, or move during the heart rate, a noninvasive blood pressure and BIS Index recordings before the propofol infusion and the sedation level was assessed until the patient's unconsciousness.

Tracking Information

NCT #
NCT03429309
Collaborators
Not Provided
Investigators
Not Provided