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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
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BIS Guided | Experimental | 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 |
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| BIS Blinded | No Intervention | The anesthesia protocol used in closed BIS is carried out like general anesthesia without using BIS. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BIS | Device | 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
| D000071257 | Emergence Delirium |
| D009085 | Mucopolysaccharidosis IV |
| D053120 | Respiratory Aspiration |
| D011183 | Postoperative Complications |
| ID | Term |
|---|---|
| D003693 | Delirium |
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
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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
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The anesthesia protocol used in closed BIS is carried out like general anesthesia without using BIS.
| 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 |
| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D009083 | Mucopolysaccharidoses |
| D002239 | Carbohydrate Metabolism, Inborn Errors |
| D008661 | Metabolism, Inborn Errors |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D016464 | Lysosomal Storage Diseases |
| D017520 | Mucinoses |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |