Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06619730
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-07
Brief Title:
Brain Function Monitoring During Surgery
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Using Brain Function Monitors to Guide Anesthetic Management in Improving Anesthesia Recovery a Randomized Pilot Study to Compare Outcomes in Young Adult Patients
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this research is to gather information on the effectiveness of the Sedline Brain Function Monitor and its use in this study to determine whether monitoring the brain activity during anesthesia will improve recovery including earlier discharge and less side effects Furthermore the study team wants to determine whether males and females respond to anesthetics in a similar manner with and without brain monitoring
Detailed Description:
Screening One day prior to surgery or the day-of surgery in the preoperative holding area Once potentially appropriate subjects have been identified from the OR schedule for the next day the study team will contact the anesthesia provider resident nurse aestheticist attending who is scheduled to treat that patient and explain to himher about the research project and ask them to use a Sedline Brain Function Monitor for the case In explaining the research project to anesthesia providers the study team will stress the importance of keeping the patients Sedline Density Spectral Array DSA between 8-15 orand Patient State Index PSI reading between 25-50 throughout the course of the case in the subjects who are randomly selected in the monitoring group If the blood pressure BP or heart rate HR is over 25-30 baseline an opioid or other pain medications will be used first before increasing the dose of inhalational agent or propofol If BP is low and PSI is on the low end study team will lower the inhalational agent or propofol first If the patient moves and BP and PSI are within the ranges muscle relaxant may be given first unless the use of muscle relaxant is not allowed for the surgical reason If both opioids and muscle relaxant adjustment fail to achieve the hemodynamic stability and immobility goal then the study team will adjust the doses of inhalational agent or propofol
Treatment During general anesthesia for surgery projected to last 60-240 mins The study team will try to treat the need of each component in general anesthesia unconsciousness immobility nociception and hemodynamic stability accordingly while the study team understands the 4 components are interlinked In the non-monitoring group control or conventional group the anesthesia providers will administer the anesthetics in the conventional manner mainly based on the hemodynamic responses and the minimum alveolar concentration MAC of inhalational agents during the surgery The brain activities are not usually monitored in real time by a brain monitor The anesthesia providers are allowed to use inhalational intravenous anesthetic agents opioids and muscle relaxants to produce adequate general anesthesia in both groups Overall anesthesia care during the surgery will not be compromised
On the day of planned surgery the study team will meet with each patient in pre-op and ask for their informed consent to participate in this research If they agree to participate their anesthesia provider will apply a Sedline Monitor to their forehead during the general anesthesia procedure The anesthesia provider may use the data from the monitor to affect their anesthetic administration or may cover the data from the monitor and only use conventional measures to guide anesthetic dosing in these control cases blood pressure heart rate body movement respiratory rate MAC of inhalational agent depending on what group into which the patient has been randomized
Once the general anesthesia procedure is over and the patient is recovering in pediatric acute care unit PACU the study team will meet with each patient again and use a standardized survey to ask about their satisfaction with their anesthetic including questions about their post-operative pain and feelings of nausea or presence of vomiting
Follow-up Follow up on postoperative day 1 via phone call The study team will follow-up with each patient via phone call on post-op Day 1 and ask the same survey questions to ensure resolution of their symptoms and timing of the resolution of their symptoms The study time will also ask the PACU nurse to record at what time the patient met the University of Chicago Medical Center UCMC-specific PACU discharge protocol criteria
Treatment During general anesthesia for surgery projected to last 60-240 mins The study team will try to treat the need of each component in general anesthesia unconsciousness immobility nociception and hemodynamic stability accordingly while the study team understands the 4 components are interlinked In the non-monitoring group control or conventional group the anesthesia providers will administer the anesthetics in the conventional manner mainly based on the hemodynamic responses and the minimum alveolar concentration MAC of inhalational agents during the surgery The brain activities are not usually monitored in real time by a brain monitor The anesthesia providers are allowed to use inhalational intravenous anesthetic agents opioids and muscle relaxants to produce adequate general anesthesia in both groups Overall anesthesia care during the surgery will not be compromised
On the day of planned surgery the study team will meet with each patient in pre-op and ask for their informed consent to participate in this research If they agree to participate their anesthesia provider will apply a Sedline Monitor to their forehead during the general anesthesia procedure The anesthesia provider may use the data from the monitor to affect their anesthetic administration or may cover the data from the monitor and only use conventional measures to guide anesthetic dosing in these control cases blood pressure heart rate body movement respiratory rate MAC of inhalational agent depending on what group into which the patient has been randomized
Once the general anesthesia procedure is over and the patient is recovering in pediatric acute care unit PACU the study team will meet with each patient again and use a standardized survey to ask about their satisfaction with their anesthetic including questions about their post-operative pain and feelings of nausea or presence of vomiting
Follow-up Follow up on postoperative day 1 via phone call The study team will follow-up with each patient via phone call on post-op Day 1 and ask the same survey questions to ensure resolution of their symptoms and timing of the resolution of their symptoms The study time will also ask the PACU nurse to record at what time the patient met the University of Chicago Medical Center UCMC-specific PACU discharge protocol criteria
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None