Efficacy of BIS Monitoring in Deep Hypnotic State

NCT06177847 | Unknown DMC

• 1 other identifier: IndonesiaU432
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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

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

Outcome Measures

Primary Outcomes (8)

• 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

Study Arms (2)

BIS Guided

EXPERIMENTAL

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

BIS Blinded

NO INTERVENTION

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

Interventions

BIS 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 Guided

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Indonesia University: lead

MeSH Terms

Conditions

Nervous System Diseases; Emergence Delirium; Mucopolysaccharidosis IV; Respiratory Aspiration; Postoperative Complications

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Mucopolysaccharidoses; Carbohydrate Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Lysosomal Storage Diseases; Mucinoses; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Respiration Disorders; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: The anesthesia protocol used in closed BIS is carried out like general anesthesia without using BIS.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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

Study Record Dates

• First Submitted: September 21, 2023
• First Posted: December 20, 2023
• Study Start: December 15, 2023
• Primary Completion: January 30, 2024
• Study Completion: February 28, 2024
• Last Updated: December 20, 2023

Record last verified: 2023-12