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

Effect of Sedatives Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04248075
• Other study ID #: 20200120
• Status: Not yet recruiting
• Start date: April 1, 2020
• Est. completion date: February 28, 2021

Study information

• Verified date: January 2020
• Source: SMG-SNU Boramae Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: February 28, 2021
• Est. primary completion date: February 20, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• Eldery patients scheduled for spinal anesthesia

Exclusion Criteria:

• MMSE = 23

• Hemodynamic unstability

• Liver disease

• Renal disease

Related Conditions & MeSH terms

• Effect of Sedatives

Intervention

Device:
• Electroencephalogram
Electroencephalogram is performed before, during, and 1 day after surgery in elderly patients undergoing spinal anesthesia.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
SMG-SNU Boramae Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	EEG frequency bands (alpha, beta, theta, delta, and gamma waves) during spinal anesthesia	EEG frequency bands are observed during spinal anesthesia under sedated or unsedated states.	30 min after the induction of spinal anesthesia
Secondary	EEG frequency bands (alpha, beta, theta, delta, and gamma waves) 1 day after surgery	EEG frequency bands are observed after surgery and compared with the preoperative findings.	1 day after surgery
Secondary	Incidence of delirium	Delirium is assessed after surgery.	For 7 days after surgery.