Efficacy of BIS Monitoring in Deep Hypnotic State

NCT ID: NCT06177847

Last Updated: 2023-12-20

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-15
• Study Completion Date: 2024-02-28

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

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

BIS Guided

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

Group Type: EXPERIMENTAL

BIS

Intervention Type: 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

BIS Blinded

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

BIS

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

Intervention Type: DEVICE

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Indonesia University

OTHER

Sponsor Role: lead

Responsible Party

Bintang Pramodana

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

IndonesiaU432

Identifier Type: -

Identifier Source: org_study_id