Comparison of DHT Duration in Geriatric Patients Using BIS Monitoring

NCT ID: NCT06394362

Last Updated: 2024-05-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-01
• Study Completion Date: 2024-02-10

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

Experimental monitoring group with BIS

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

Group Type: EXPERIMENTAL

Bispectral index monitor

Intervention Type: 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.

Control monitoring group without BIS

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 61 Years
• Maximum Eligible Age: 71 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Indonesia University

OTHER

Sponsor Role: lead

Responsible Party

Riyadh Firdaus

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Cipto Mangunkusumo Central National Hospital

Jakarta, , Indonesia

Countries

Indonesia

Other Identifiers

IndonesiaU230424

Identifier Type: -

Identifier Source: org_study_id