Effect of Sedatives on Perioperative Electroencephalogram in Elderly Patients Undergoing Spinal Anesthesia
1 other identifier
observational
120
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Apr 2020
Shorter than P25 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 22, 2020
CompletedFirst Posted
Study publicly available on registry
January 30, 2020
CompletedStudy Start
First participant enrolled
April 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 20, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2021
CompletedJanuary 30, 2020
January 1, 2020
11 months
January 22, 2020
January 29, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
EEG frequency bands (alpha, beta, theta, delta, and gamma waves) 1 day after surgery
1 day after surgery
Incidence of delirium
For 7 days after surgery.
Study Arms (4)
Control
Patients who do not want to be sedated during spinal anesthesia are included. Electroencephalogram is performed before, during, and 1 day after surgery.
Dexmedetomidine
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.
Propofol
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
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.
Interventions
Electroencephalogram is performed before, during, and 1 day after surgery in elderly patients undergoing spinal anesthesia.
Eligibility Criteria
Elderly patients scheduled to undergo total knee arthroplasty under spinal anesthesia
You may qualify if:
- Eldery patients scheduled for spinal anesthesia
You may not qualify if:
- MMSE ≤ 23
- Hemodynamic unstability
- Liver disease
- Renal disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate professor
Study Record Dates
First Submitted
January 22, 2020
First Posted
January 30, 2020
Study Start
April 1, 2020
Primary Completion
February 20, 2021
Study Completion
February 28, 2021
Last Updated
January 30, 2020
Record last verified: 2020-01