Efficacy of BIS Monitoring in Deep Hypnotic State

Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06177847
• Other study ID #: IndonesiaU432
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 15, 2023
• Est. completion date: February 28, 2024

Study information

• Verified date: December 2023
• Source: Indonesia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: February 28, 2024
• Est. primary completion date: January 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia
• Anesthesia Emergence Delirium
• Confusion
• Delirium
• Emergence Delirium
• Gas; Inhalation
• Nervous System Diseases
• Neurological Disorder
• Postoperative Confusion
• Postoperative Delirium

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Indonesia University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Incidence of mortality	The incidence of death after surgery in hospital or outside the hospital	up to 28 days after surgery
Primary	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
Primary	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