Clinical trial NCT06177847: Efficacy of BIS Monitoring in Deep Hypnotic State
Official title: Efficacy of BIS Monitoring in Deep Hypnotic State and Its Outcome on Patient Undergoing Elective Neurosurgery
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hypnotic; Withdrawal State With Delirium
Neurological Disorder
Postoperative Delirium
Postoperative Confusion
Anesthesia
Anesthesia Emergence Delirium
Gas; Inhalation
Keywords: Deep Hypnotic State
Anesthesia
Postoperative complication
Neurosurgical disorder
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2023-12-20
Enrollment: 50
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Deep Hypnotic State
timeFrame: During surgery and up to 24 hours after surgery
measure: Total use of anesthetic agents
timeFrame: During surgery and up to 24 hours after surgery
measure: Number of Participants with Hypotension and Bradycardia Intraoperative
timeFrame: During surgery and up to 24 hours after surgery
measure: Vasopressor use
timeFrame: Before surgery, during surgery, up to 24 hours after surgery
measure: Incidence of delirium
timeFrame: up to 24 hour after surgery
measure: Incidence of mortality
timeFrame: up to 28 days after surgery
measure: Lenght of stay
timeFrame: From the date of randomization until 28 days after surgery
measure: Duration of recovery
timeFrame: up to 7 days post operative
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: