Efficacy of BIS Monitoring in Deep Hypnotic State

Not Applicable

Not yet recruiting

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

• Registration Number: NCT06177847
• Lead Sponsor: Indonesia University

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

Study Timeline

• Study First Submitted: 2023-09-21
• Status Verified: 2023-12
• Study First Submitted QC: 2023-12-10
• Last Update Submitted: 2023-12-10
• Study Start: 2023-12-15
• Study First Posted: 2023-12-20
• Last Update Posted: 2023-12-20
• Primary Completion: 2024-01-30
• Study Completion: 2024-02-28

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BIS Guided	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

Primary Outcome Measures

Name	Time	Method
Total use of anesthetic agents	During surgery and up to 24 hours after surgery	The amount of anesthetic gas used from the start of the operation to the end of the operation
Deep Hypnotic State	During surgery and up to 24 hours after surgery	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.
Vasopressor use	Before surgery, during surgery, up to 24 hours after surgery	Use of vasopressor agents (dopamine, dobutamine, norepinephrine, epinephrine, etc.) will be calculated and totaled at the end of surgery.
Lenght of stay	From the date of randomization until 28 days after surgery	The length of stay is measured from days after surgery until being discharged from the hospital.
Incidence of delirium	up to 24 hour after surgery	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
Incidence of mortality	up to 28 days after surgery	The incidence of death after surgery in hospital or outside the hospital
Duration of recovery	up to 7 days post operative	The duration of recovery was measured from post-operative day 0 until the patient was able to return to the patient's baseline function
Number of Participants with Hypotension and Bradycardia Intraoperative	During surgery and up to 24 hours after surgery	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