Efficacy of BIS Monitoring in Deep Hypnotic State

Study Overview
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Brief Summary
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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
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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

Official Title
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Efficacy of BIS Monitoring in Deep Hypnotic State and Its Outcome on Patient Undergoing Elective Neurosurgery

Conditions
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Hypnotic; Withdrawal State With Delirium, Neurological Disorder, Postoperative Delirium, Postoperative Confusion, Anesthesia, Anesthesia Emergence Delirium, Gas; Inhalation

Intervention / Treatment
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* Device: BIS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged 30-60 years with an ASA tolerance of 1-2 who will undergo general anesthesia techniques Operation duration > 3 hours The patient agrees to take part in the study. Exclusion Criteria: Continuous intraoperative use of ketamine, magnesium sulfate, dexmedetomidine, lidocaine agents Massive bleeding that causes hemodynamic disturbances Severe electrolyte disturbances Severe liver or kidney function disorders The patient was decided not to extubate in the operating room

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: In the group with BIS where the anesthesia protocol is opened, namely the use of anesthetic gas, the anesthetic drug will be adjusted to the BIS value range of 40-60 or BIS-guided
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BIS Guided<br>In the group with BIS where the anesthesia protocol is opened, namely the use of anesthetic gas, the anesthetic drug will be adjusted to the BIS value range of 40-60 or BIS-guided | Device: BIS<br>* In the group with BIS where the anesthesia protocol is opened, namely the use of anesthetic gas, the anesthetic drug will be adjusted to the BIS value range of 40-60 or BIS-guided<br>|
| No Intervention: BIS Blinded<br>The anesthesia protocol used in closed BIS is carried out like general anesthesia without using BIS. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Deep Hypnotic State | the state of depth of anesthesia where the Bispectral Index value is <40. is calculated from the beginning of induction to the end of the operation and accumulated at the end of the operation. | During surgery and up to 24 hours after surgery | 
| Total use of anesthetic agents | The amount of anesthetic gas used from the start of the operation to the end of the operation | During surgery and up to 24 hours after surgery | 
| Number of Participants with Hypotension and Bradycardia Intraoperative | Intraoperative hypotension was defined as systolic blood pressure <90 mm Hg for >5 minutes or a 35% decrease in MAP. Intraoperative bradycardia was defined as a heart rate <60 beats/min for >5 minutes | During surgery and up to 24 hours after surgery | 
| Vasopressor use | Use of vasopressor agents (dopamine, dobutamine, norepinephrine, epinephrine, etc.) will be calculated and totaled at the end of surgery. | Before surgery, during surgery, up to 24 hours after surgery | 
| Incidence of delirium | The method for measuring the incidence of delirium will be assessed by researchers using the CAM (Confusion Assessment Method) questionnaire which has been validated in Indonesian | up to 24 hour after surgery | 
| Incidence of mortality | The incidence of death after surgery in hospital or outside the hospital | up to 28 days after surgery | 
| Lenght of stay | The length of stay is measured from days after surgery until being discharged from the hospital. | From the date of randomization until 28 days after surgery | 
| Duration of recovery | The duration of recovery was measured from post-operative day 0 until the patient was able to return to the patient's baseline function | up to 7 days post operative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Deep Hypnotic State, Anesthesia, Postoperative complication, Neurosurgical disorder