Comparison of DHT Duration in Geriatric Patients Using BIS Monitoring

General Anesthesia Clinical Trial

Official title:

Comparison of Deep Hypnotic Time Duration in Geriatric Patients Undergoing General Anesthesia With Additional Bispectral Index Monitoring Compared to Standard Monitoring at Cipto Mangunkusumo Hospital in 2023

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06394362
• Other study ID #: IndonesiaU230424
• Status: Completed
• Phase: N/A
• Start date: November 1, 2023
• Est. completion date: February 10, 2024

Study information

• Verified date: April 2024
• Source: Indonesia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Without adequate monitoring, administration of anesthetic agents can create unnecessary deeper anesthetic plane in geriatric population. This study aims to compare the duration of deep hypnotic time (DHT) in geriatric patients undergoing general anesthesia with additional BIS monitor compared to standard monitoring. This study was a randomized clinical trial involving 44 geriatric patients undergoing general anesthesia. Subjects are divided into two groups, one with additional BISTM monitor and the other with standard monitoring. Data acquired from BISTM will continually be recorded to be analyzed afterward

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: February 10, 2024
• Est. primary completion date: January 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 61 Years to 71 Years

Eligibility

Inclusion Criteria:

• Sampling was consecutively conducted on geriatric patients aged >60 years undergoing general anesthesia for procedures lasting >2 hours with ASA physical status 1-3 and willing to participate in the study

Exclusion Criteria:

• Exclusion criteria included intracranial procedures, unstable hemodynamic conditions, neurocognitive impairment, and if the patient was anticipated not to be extubated at the end of the surgical procedure. Patients could be excluded if the preoperative MMSE score was <24, undergoing general anesthesia using a combination of ketamine and/or N20 agents, experiencing emergencies during surgery, and losing BIS data >10% of the duration of the operation

Related Conditions & MeSH terms

• General Anesthesia

Intervention

Other:
• Bispectral index monitor
Bispectral Index (BIS), that was introduced in 1992, is a tool that monitors the depth level of hypnosis through data processing of an electroencephalogram using computer algorithm and presented in the form of processed EEG. Utilizing BIS as a monitoring tool has shown effectiveness in reducing recovery time, prevent awareness, and bring down the amount of anesthesia agent however, as of now, it has not been incorporated into the 2020 American Society of Anesthesiologists (ASA) standard procedure on anesthesia monitoring. aims to comparing the deep hypnotic time duration on two group of geriatric patients which undergoes general anesthesia with BIS monitoring compared to standard monitoring.

Locations

Country	Name	City	State
Indonesia	Cipto Mangunkusumo Central National Hospital	Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
Indonesia University

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Deep Hypnotic time duration with Bispectral Index Monitoring	Deep Hypnotic Time is the period during the Bispectral Index (BIS) are extensively less than 40 (a scale of 0 - 100). The BIS value that is believed to prevent 50% of the population from responding to verbal instructions placed on an index value of 67 - 79. Targeted BIS value to prevent awareness under general anesthesia are at a range of 40 - 60. A study conducted using BIS, shows that under a standard care, BIS value during operative maintenance period tends to be lower which sat around 36 (31 - 49). Duration is the lower the DHT duration the better the outcome of the patient, duration is measured in minutes	24 hours
Secondary	Mini Mental State Examination exam before and after operation in both control and experimental group	patients mental state is examined by using MMSE test to find an objective screening method of cognitive function (lost score = 0, maximum score = 40), scoring category : 0 - 10 MMSE Score = Severe Cognitive Impairment 10 - 20 MMSE Score = Moderate Cognitive Impairment 20 - 25 MMSE Score = Mild Cognitive Impairment 25 - 30 MMSE Score = Questionably Significant / Maybe Normal Cognitive	24 hours