Efficacy of BIS Monitoring in Deep Hypnotic State

University of Indonesia (UI)

Status: Not yet enrolling

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

Treatments: Device: BIS

Study type: Interventional

Funder types: Other

Identifiers

NCT06177847

IndonesiaU432

Details and patient eligibility

About

Determining the efficacy of the BIS monitor in monitoring deep hypnotic states as well as intra- and post-operative outcomes in neurosurgery patients

Full 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

Enrollment: 50 estimated patients

Sex: All

Ages: 30 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups

BIS Guided

Experimental group

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

Treatment:

Device: BIS

BIS Blinded

No Intervention group

Description:

The anesthesia protocol used in closed BIS is carried out like general anesthesia without using BIS.