Comparison of DHT Duration in Geriatric Patients Using BIS Monitoring

University of Indonesia (UI)

Status: Completed

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

Treatments: Other: Bispectral index monitor

Study type: Interventional

Funder types: Other

Identifiers

NCT06394362

IndonesiaU230424

Details and patient eligibility

About

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

Enrollment: 44 patients

Sex: All

Ages: 61 to 71 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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44 participants in 2 patient groups

Experimental monitoring group with BIS

Experimental group

Description:

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

Treatment:

Other: Bispectral index monitor

Control monitoring group without BIS

No Intervention group

Description:

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