Validation of objective evaluation of anxiety and stress during surgery by monitoring blood oxygen saturation in the brain of elderly patients 65 years or older

Validation of objective evaluation of anxiety and stress during surgery with NIRSIT ON (NO1-M40AM) in elderly patients 65 years or older

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0007692

Enrollment

Registered

2022-09-15

Start date

2020-01-09

Completion date

Unknown

Last updated

2022-10-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Medical Device : We randomly divided 60 patients into 3 groups (20 patients per group) to have different levels of anxiety, and the intensity of intraoperative sedation after spinal anesthesia was dif

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients are 65 years of age or older, ASA (American Society of Anaesthesiologists) physical status I or II, and among patients scheduled for knee replacement surgery under spinal anesthesia, and they must not have previously diagnosed psychiatric, neurological or cognitive disorder.

Exclusion criteria

Exclusion criteria: Patients or guardians who do not consent to the study Patients with already diagnosed psychiatric, neurological or cognitive disorder. Patients who are contraindicated in spinal anesthesia Patients with hypersensitivity to local anesthetics

Design outcomes

Primary

Measure	Time frame
Functional near-infrared spectroscopy (fNIRS);State trait anxiety inventory (STAI)	—

Secondary

Measure	Time frame
Ramsay sedation scale (RSS);Intraoperative Vital Sign	—

Countries

Korea, Republic of

Contacts

Public ContactDowon Lee

Pusan National University Hospital

drldw03@naver.com+82-51-240-7399

Outcome results