Electroencephalographic Characteristics of Chronic Pain in Patients With Spinal Cord Injury
NCT ID: NCT06531837
Last Updated: 2024-08-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
60 participants
INTERVENTIONAL
2024-08-25
2026-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Patients without pain
No intervention
Collect resting-state EEG data and NRS scores.
Patients with chronic pain treated with esketamine
Esketamine(Continuous infusion)
Continuous intravenous infusion of esketamine at a dose of 0.2 mg/(kg · h). Collect resting-state EEG data and NRS scores 40 minutes after administration.
Spinal Cord Stimulation
Collect resting-state EEG data and NRS scores with the spinal cord stimulator both turned off and on.
Patients with chronic pain treated with remifentanil
Remifentanil (Target-Controlled Infusion)
The plasma drug concentrations of remifentanil were set at 0.5 ng/ml, 1 ng/ml, and 1.5 ng/ml. After each plasma drug concentration reached a steady state, the NRS scores were assessed, and resting-state EEG was recorded for at least 5 minutes.
Spinal Cord Stimulation
Collect resting-state EEG data and NRS scores with the spinal cord stimulator both turned off and on.
Patients with chronic pain treated with flurbiprofen
Flurbiprofen (Single intravenous injection)
Single intravenous injection of Flurbiprofen at a dose of 100 mg. Collect resting-state EEG data and NRS scores 10 minutes after administration.
Spinal Cord Stimulation
Collect resting-state EEG data and NRS scores with the spinal cord stimulator both turned off and on.
Interventions
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Esketamine(Continuous infusion)
Continuous intravenous infusion of esketamine at a dose of 0.2 mg/(kg · h). Collect resting-state EEG data and NRS scores 40 minutes after administration.
Remifentanil (Target-Controlled Infusion)
The plasma drug concentrations of remifentanil were set at 0.5 ng/ml, 1 ng/ml, and 1.5 ng/ml. After each plasma drug concentration reached a steady state, the NRS scores were assessed, and resting-state EEG was recorded for at least 5 minutes.
Flurbiprofen (Single intravenous injection)
Single intravenous injection of Flurbiprofen at a dose of 100 mg. Collect resting-state EEG data and NRS scores 10 minutes after administration.
Spinal Cord Stimulation
Collect resting-state EEG data and NRS scores with the spinal cord stimulator both turned off and on.
No intervention
Collect resting-state EEG data and NRS scores.
Eligibility Criteria
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Inclusion Criteria
* American Society of Anesthesiologists (ASA) I-III;
* Dextromanual;
* Chronic Pain following Spinal Cord Injury;
* Spinal cord electrical stimulator implantation under general anesthesia;
* Signed informed consent.
* Age 18 - 65 years old;
* American Society of Anesthesiologists (ASA) I-III;
* Dextromanual;
* Spinal Cord Injury Patients Without Pain;
* Spinal cord electrical stimulator implantation under general anesthesia;
* Signed informed consent.
Exclusion Criteria
* Previous history of craniocerebral disease;
* History of drug and alcohol abuse;
* Patients with aphasia or inability to cooperate with the pain assessments;
* Previous adverse reaction to esketamine, opioids or NSAIDs;
* Known sever insufficiency of vitals(such as heart failure/renal dysfunction/hepatic failure);
* Patients with myasthenia gravis, bronchial asthma, or a predisposition to respiratory depression;
* Bleeding tendency;
* BMI ≥ 35 kg/m²;
* Pregnancy or lactation.
Spinal Cord Injury Patients Without Pain
* People with mental and behavioral disorders.
* Previous history of craniocerebral disease;
* History of drug and alcohol abuse;
* Patients with aphasia or inability to cooperate with the pain assessments;
* Previous adverse reaction to esketamine, opioids or NSAIDs;
* Known sever insufficiency of vitals(such as heart failure/renal dysfunction/hepatic failure);
* Patients with myasthenia gravis, bronchial asthma, or a predisposition to respiratory depression;
* Bleeding tendency;
* BMI ≥ 35 kg/m²;
* Pregnancy or lactation.
18 Years
65 Years
ALL
No
Sponsors
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Beijing Tiantan Hospital
OTHER
Responsible Party
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Ruquan Han
Professor
Principal Investigators
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Ruquan Han, M.D., Ph D
Role: STUDY_CHAIR
Beijing Tiantan Hospital
Locations
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Beijing Tiantan Hospital
Beijing, , China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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zz20240512
Identifier Type: -
Identifier Source: org_study_id
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