Effect of SedativesNCT04248075
Effect of Sedatives on Perioperative Electroencephalogram in Elderly Patients Undergoing Spinal Anesthesia
An observational study of Effect of Sedatives, run by SMG-SNU Boramae Medical Center.
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Effect of Sedatives
- What is being tested?
- Electroencephalogram
- Type of treatment
- Medical device
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2020to 28 Feb 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Elderly patients scheduled to undergo total knee arthroplasty under spinal anesthesia
Who may be able to join
- Eldery patients scheduled for spinal anesthesia
Who cannot join
- MMSE ≤ 23
- Hemodynamic unstability
- Liver disease
- Renal disease
About this study
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.
- Conditions
- Effect of Sedatives
- Being tested
- Electroencephalogram
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElectroencephalogramDevice
Electroencephalogram is performed before, during, and 1 day after surgery in elderly patients undergoing spinal anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| Control | Patients who do not want to be sedated during spinal anesthesia are included. Electroencephalogram is performed before, during, and 1 day after surgery. Receives: 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. Receives: 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. Receives: 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. Receives: Device: Electroencephalogram |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
EEG frequency bands are observed after surgery and compared with the preoperative findings.
Measured: 1 day after surgery
Incidence of delirium
Delirium is assessed after surgery.
Measured: For 7 days after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2020
- Study start1 Apr 2020 (estimated)
- Primary completion20 Feb 2021 (estimated)
- Study completion28 Feb 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Effect of SedativesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SMG-SNU Boramae Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin-Young Hwang, SMG-SNU Boramae Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04248075
- Sponsor's protocol ID
- 20200120
- Status last verified
- Jan 2020
- First submitted
- 22 Jan 2020
- Last updated
- 30 Jan 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Sedatives on Perioperative Electroencephalogram in Elderly Patients Undergoing Spinal Anesthesia
- ClinicalTrials.gov ID
- NCT04248075
- Acronym / sponsor ID
- 20200120
- Conditions
- Effect of Sedatives
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- SMG-SNU Boramae Medical CenterUniversity, hospital or other
- Study start
- 1 Apr 2020 (estimated)
- Primary completion
- 20 Feb 2021 (estimated)
- Study completion
- 28 Feb 2021 (estimated)
- First posted
- 30 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control | – | Device: ElectroencephalogramPatients who do not want to be sedated during spinal anesthesia are included. Electroencephalogram is performed before, during, and 1 day after surgery. |
| Dexmedetomidine | – | Device: ElectroencephalogramPatients 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 | – | Device: ElectroencephalogramPatients 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 | – | Device: ElectroencephalogramPatients 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Elderly patients scheduled to undergo total knee arthroplasty under spinal anesthesia
Key inclusion criteria (1 listed)
- Eldery patients scheduled for spinal anesthesia
Key exclusion criteria (4 listed)
- MMSE ≤ 23
- Hemodynamic unstability
- Liver disease
- Renal disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ElectroencephalogramElectroencephalogram is performed before, during, and 1 day after surgery in elderly patients undergoing spinal anesthesia. | Device | Control, Dexmedetomidine, Midazolam, Propofol |
Primary outcome
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.
2 secondary outcomes
EEG frequency bands (alpha, beta, theta, delta, and gamma waves) 1 day after surgery
Time frame: 1 day after surgery
Incidence of delirium
Time frame: For 7 days after surgery.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Effect of Sedatives, run by SMG-SNU Boramae Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EEG frequency bands (alpha, beta, theta, delta, and gamma waves) during spinal anesthesia (time frame: 30 min after the induction of spinal anesthesia). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2020.