Ignite Creation Date:
2024-05-06 @ 6:47 PM
Last Modification Date:
2024-10-26 @ 2:55 PM
Study NCT ID:
NCT05789992
Status:
COMPLETED
Last Update Posted:
2023-06-15
First Post:
2023-03-02
Brief Title:
Evaluation of Equivalent Minimum Alveolar Concentration eMAC During PropofolRemifentanil Anesthesia
Sponsor:
Zhang Haopeng
Organization:
Xijing Hospital
Study Overview
Official Title:
Detection of Nociceptive Stimulation and Anesthesia State by Equivalent Minimum Alveolar Concentration eMAC During Anesthesia With Varying Propofol and Remifentanil Concentrations
Status:
COMPLETED
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
eMAC
Brief Summary:
The aim of this study is to verify the accuracy of eMAC compared to Bispectral Index BIS for depth and nociceptive stimulation monitoring of anesthesia during general anesthesia
Detailed Description:
eMAC is a new index based on response surface model for evaluating anesthesia state and anti-nociceptive stimulation levels To valid its clinical accuracy a protocol was designed
Patients will be allocated to receive a specific effect-site concentration of remifentanil and propofol during tonic electrical stimulation 5s 50mA and intubation The concentration combinations include the electrical stimulation combination effector chamber concentration random remifentanil 0-3 ngml propofol 3-5 ugml and the intubation combination effector chamber concentration random remifentanil 3-5 ngml propofol 3-5 ugml All combinations were decided before operation Every combination had a 5 min equilibration period and the vital signs Heart Rate Blood pressure any body movement and BIS eMAC will be recorded before and after the electrical stimulation and intubation After this period patients will be randomly allocated to receive an intravenous anesthesia or intravenous combined anesthesia and regular anesthesia is executed This study only records vital signs and BIS eMAC during maintenance period of perioperative
Patients will be allocated to receive a specific effect-site concentration of remifentanil and propofol during tonic electrical stimulation 5s 50mA and intubation The concentration combinations include the electrical stimulation combination effector chamber concentration random remifentanil 0-3 ngml propofol 3-5 ugml and the intubation combination effector chamber concentration random remifentanil 3-5 ngml propofol 3-5 ugml All combinations were decided before operation Every combination had a 5 min equilibration period and the vital signs Heart Rate Blood pressure any body movement and BIS eMAC will be recorded before and after the electrical stimulation and intubation After this period patients will be randomly allocated to receive an intravenous anesthesia or intravenous combined anesthesia and regular anesthesia is executed This study only records vital signs and BIS eMAC during maintenance period of perioperative
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None