Comparison of DHT Duration in Geriatric Patients Using BIS Monitoring

NCT06394362 | Completed

• 1 other identifier: IndonesiaU230424
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Deep Hypnotic Time; Emergence Time; Geriatric Population; General Anesthesia

Keywords

bispectral index; deep hypnotic time; emergence time; mini mental state exam; geriatric population

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  24 hours

Study Arms (2)

Experimental monitoring group with BIS

EXPERIMENTAL

Subjects who meet the study criteria and has signed the inform consent will be randomized in a 1:1 ratio into 2 groups, namely Group A undergoing general anesthesia with additional BIS monitoring. When the patient arrives in the preparation room approximately 1 hour before surgery, MMSE evaluation is conducted to obtain preoperative MMSE data. Before anesthesia induction, monitoring and BIS sensor placement are performed

Other: Bispectral index monitor

Control monitoring group without BIS

NO INTERVENTION

Subjects who meet the study criteria and has signed the inform consent will be randomized in a 1:1 ratio into 2 groups, Group B undergoing general anesthesia with standard monitoring according to ASA. When the patient arrives in the preparation room approximately 1 hour before surgery, MMSE evaluation is conducted to obtain preoperative MMSE data. The BIS monitor for patients in Group B is then covered (hidden BIS), so that the data cannot be viewed by the anesthesia team performing the anesthesia

Interventions

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.

Experimental monitoring group with BIS

Eligibility Criteria

• Age: 61 Years - 71 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (1)

Cipto Mangunkusumo Central National Hospital

Jakarta, 10430, Indonesia

Location

MeSH Terms

Interventions

Consciousness Monitors

Intervention Hierarchy (Ancestors)

Surgical Equipment; Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: April 24, 2024
• First Posted: May 1, 2024
• Study Start: November 1, 2023
• Primary Completion: January 31, 2024
• Study Completion: February 10, 2024
• Last Updated: May 1, 2024

Record last verified: 2024-04

Locations

ID (1)