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

January 29, 2020 updated by: Jin-Young Hwang, SMG-SNU Boramae Medical Center
In the present study, we observe perioperative findings of electroencephalogram in sedated and non-sedated elderly patients undergoing total knee arthroplasty under spinal anesthesia.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

120

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Elderly patients scheduled to undergo total knee arthroplasty under spinal anesthesia

Description

Inclusion Criteria:

  • Eldery patients scheduled for spinal anesthesia

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Electroencephalogram is performed before, during, and 1 day after surgery in elderly patients undergoing spinal anesthesia.
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
Electroencephalogram is performed before, during, and 1 day after surgery in elderly patients undergoing spinal anesthesia.
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
Electroencephalogram is performed before, during, and 1 day after surgery in elderly patients undergoing spinal anesthesia.
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
Electroencephalogram is performed before, during, and 1 day after surgery in elderly patients undergoing spinal anesthesia.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SMG-SNU Boramae Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 1, 2020

Primary Completion (Anticipated)

February 20, 2021

Study Completion (Anticipated)

February 28, 2021

Study Registration Dates

First Submitted

January 22, 2020

First Submitted That Met QC Criteria

January 29, 2020

First Posted (Actual)

January 30, 2020

Study Record Updates

Last Update Posted (Actual)

January 30, 2020

Last Update Submitted That Met QC Criteria

January 29, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • 20200120

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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