Effect of Sedatives on Perioperative Electroencephalogram in Elderly Patients Undergoing Spinal Anesthesia

• Conditions: Effect of Sedatives
• Interventions: Device: Electroencephalogram

• Registration Number: NCT04248075
• Lead Sponsor: SMG-SNU Boramae Medical Center

Brief Summary

In the present study, we observe perioperative findings of electroencephalogram in sedated and non-sedated elderly patients undergoing total knee arthroplasty under spinal anesthesia.

Detailed Description

In the present study, we observe perioperative findings of electroencephalogram in sedated and non-sedated elderly patients undergoing total knee arthroplasty under spinal anesthesia. Electroencephalogram is performed before, during, and 1 day after surgery.

After the induction of anesthesia, sedation is performed according to the patient's request. If a patient want to be sedated during surgery, one of the three sedatives (dexmedetomidine, propofol, and midazolam) is administered.

Study Timeline

• Status Verified: 2020-01
• Study First Submitted: 2020-01-22
• Study First Submitted QC: 2020-01-29
• Last Update Submitted: 2020-01-29
• Study First Posted: 2020-01-30
• Last Update Posted: 2020-01-30
• Study Start: 2020-04-01
• Primary Completion: 2021-02-20
• Study Completion: 2021-02-28

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Eldery patients scheduled for spinal anesthesia

Exclusion Criteria

• MMSE ≤ 23
• Hemodynamic unstability
• Liver disease
• Renal disease

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Propofol	Electroencephalogram	Patients who want to be sedated during spinal anesthesia are included. Electroencephalogram is performed before, during, and 1 day after surgery. After the induction of spinal anestheisa, propofol is administered for sedation during surgery.
Midazolam	Electroencephalogram	Patients who want to be sedated during spinal anesthesia are included. Electroencephalogram is performed before, during, and 1 day after surgery. After the induction of spinal anestheisa, midazolam is administered for sedation during surgery.
Control	Electroencephalogram	Patients who do not want to be sedated during spinal anesthesia are included. Electroencephalogram is performed before, during, and 1 day after surgery.
Dexmedetomidine	Electroencephalogram	Patients who want to be sedated during spinal anesthesia are included. Electroencephalogram is performed before, during, and 1 day after surgery. After the induction of spinal anestheisa, dexmedetomidine is administered for sedation during surgery.

Primary Outcome Measures

Name	Time	Method
EEG frequency bands (alpha, beta, theta, delta, and gamma waves) during spinal anesthesia	30 min after the induction of spinal anesthesia	EEG frequency bands are observed during spinal anesthesia under sedated or unsedated states.

Secondary Outcome Measures

Name	Time	Method
EEG frequency bands (alpha, beta, theta, delta, and gamma waves) 1 day after surgery	1 day after surgery	EEG frequency bands are observed after surgery and compared with the preoperative findings.
Incidence of delirium	For 7 days after surgery.	Delirium is assessed after surgery.