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Status unknownNCT04248075Updated Jan 30, 2020

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

An observational study in Effect of Sedatives, sponsored by SMG-SNU Boramae Medical Center. Status unknown. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2020-01-30.

Sponsored by SMG-SNU Boramae Medical Center · Observational

The sponsor has not verified this record recently (last verified Jan 2020), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
120
Ages
65 Years and older
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Effect of Sedatives
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In context

Lead sponsor

SMG-SNU Boramae Medical Center is the lead sponsor of 38 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Elderly patients scheduled to undergo total knee arthroplasty under spinal anesthesia

Inclusion criteria

  • Eldery patients scheduled for spinal anesthesia

Exclusion criteria

Exclusion Criteria:

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

Observational model
Case-control
Time perspective
Prospective
Enrollment
120 participants (estimated)
Patient registry
No

Groups and cohorts

  • Control

    Patients who do not want to be sedated during spinal anesthesia are included. Electroencephalogram is performed before, during, and 1 day after surgery.

    Device: Electroencephalogram

  • 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.

    Device: Electroencephalogram

  • 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.

    Device: Electroencephalogram

  • 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.

    Device: Electroencephalogram

Interventions

  • DeviceElectroencephalogram

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

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What researchers measure

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.

    Time frame: 30 min after the induction of spinal anesthesia

Secondary outcomes

  1. 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.

    Time frame: 1 day after surgery

  2. Incidence of delirium

    Delirium is assessed after surgery.

    Time frame: For 7 days after surgery.

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Study locations

No study locations are listed for this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 30, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04248075
Lead sponsor
SMG-SNU Boramae Medical Center
Responsible party
Jin-Young Hwang (Associate professor, SMG-SNU Boramae Medical Center) — Principal investigator
First posted
Jan 30, 2020
Start date
Apr 1, 2020 (estimated)
Primary completion
Feb 20, 2021 (estimated)
Completion
Feb 28, 2021 (estimated)
Last update
Jan 30, 2020

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.

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