Skip to main content
OpenTrials
Completed

NCT Number: NCT06394362

Comparison of DHT Duration in Geriatric Patients Using BIS Monitoring

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Deep Hypnotic Time Emergence Time General Anesthesia Geriatric Population

Age range

61 year–71 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cipto Mangunkusumo Central National Hospital

Jakarta, 10430, Indonesia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bispectral index monitor

Other

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.

Primary outcomes

  1. Deep Hypnotic time duration with Bispectral Index Monitoring

    Time frame: 24 hours

    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

Secondary outcomes

  1. Mini Mental State Examination exam before and after operation in both control and experimental group

    Time frame: 24 hours

    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

Sponsors and collaborators

Lead sponsor

Indonesia University

Other

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
May 1, 2024
Registry last updated
May 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.