Determining the efficacy of the BIS monitor in monitoring deep hypnotic states as well as intra- and post-operative outcomes in neurosurgery patients
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
50
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
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.
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: up to 24 hour after surgery
Incidence of mortality
The incidence of death after surgery in hospital or outside the hospital
Time frame: 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.
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Time frame: 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
Time frame: up to 7 days post operative