Efficacy of BIS Monitoring in Deep Hypnotic State

Efficacy of BIS Monitoring in Deep Hypnotic State and Its Outcome on Patient Undergoing Elective Neurosurgery

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

Study Overview

• Status: Not yet recruiting
• Conditions: Postoperative Delirium; Anesthesia; Postoperative Confusion; Neurological Disorder; Anesthesia Emergence Delirium; Gas; Inhalation; Hypnotic; Withdrawal State With Delirium
• Intervention / Treatment: Device: BIS

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 Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Device: 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
No Intervention: BIS Blinded; The anesthesia protocol used in closed BIS is carried out like general anesthesia without using BIS.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: Indonesia University

Study record dates

Study Major Dates

• Study Start (Estimated): December 15, 2023
• Primary Completion (Estimated): January 30, 2024
• Study Completion (Estimated): February 28, 2024

Study Registration Dates

• First Submitted: September 21, 2023
• First Submitted That Met QC Criteria: December 10, 2023
• First Posted (Estimated): December 20, 2023

Study Record Updates

• Last Update Posted (Estimated): December 20, 2023
• Last Update Submitted That Met QC Criteria: December 10, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Anesthesia; Postoperative complication; Deep Hypnotic State; Neurosurgical disorder
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Postoperative Complications; Neurologic Manifestations; Neurobehavioral Manifestations; Neurocognitive Disorders; Delirium; Nervous System Diseases; Emergence Delirium; Confusion
• Other Study ID Numbers: IndonesiaU432

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No