Ignite Creation Date:
2024-05-06 @ 7:53 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06177847
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-12-20
First Post:
2023-09-21
Brief Title:
Efficacy of BIS Monitoring in Deep Hypnotic State
Sponsor:
Indonesia University
Organization:
Indonesia University
Study Overview
Official Title:
Efficacy of BIS Monitoring in Deep Hypnotic State and Its Outcome on Patient Undergoing Elective Neurosurgery
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-12
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:
None
Brief Summary:
Determining the efficacy of the BIS monitor in monitoring deep hypnotic states as well as intra- and post-operative outcomes in neurosurgery patients
Detailed Description:
This study will be conducted with a two-group double-blind randomized clinical trial design in elective patients who will undergo neurosurgical procedures under general anesthesia Patients scheduled for elective neurosurgery who meet the inclusion criteria will be randomized into one of the intervention groups with or without BIS Demographic data will be taken from medical records In both groups the BIS probe will be inserted before induction but for the control group the BIS monitor will be closed while for the intervention group anesthesia will be titrated according to the BIS value to maintain the BIS value in the range of 40-60 In the group with an open BIS the anesthesia protocol is the use of anesthetic gas and the anesthetic drug will be adjusted to the BIS value range of 40-60 or BIS-guided while the anesthesia protocol used in a closed BIS is carried out like general anesthesia without using BIS The BIS value will be recorded minute by minute according to the extraction feature of the BIS machine after surgery The total use of anesthetic agents duration of surgery and intraoperative hemodynamics will be recorded through anesthesia status The patient will follow the progress until the patient is discharged from the hospital
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?:
False
Is an FDA AA801 Violation?:
None