- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05900245
Anesthesia Induction Schemes of Electroconvulsive Convulsions in Patients With Depression Based on EEG Monitoring
To Explore the Influence of Different Anesthesia Induction Schemes on the Quality and Clinical Effect of Electroconvulsive Convulsions in Patients With Depression Based on EEG Monitoring
Study Overview
Status
Intervention / Treatment
Detailed Description
This study is a randomized controlled, single blind clinical trial comparing the quality of convulsions and clinical effects of electroconvulsive therapy under different levels of consciousness index (IoC).A total of 24 participants were included in this study, all from the inpatient department of the Psychiatric Department of the First Affiliated Hospital of Chongqing Medical University. They were diagnosed as depression patients according to the International Classification of Diseases (ICD-11), and their depression level and cognitive function level were evaluated by trained psychiatrists; In the study, the subjects use the EEG bispectral index monitor (Apollo-9000A) to monitor IoC1(Index of consciousness 1) and IoC2(Index of consciousness 2) before electric shock.Then anesthesia induction was performed using propofol 1.5mg/kg and scoline 1mg/kg. According to the difference in consciousness index 1 (IoC1), the subjects were randomly divided into three groups, namely H group (IoC1 60-70), M group (IoC1 50-60), and L group (IoC1 40-50). All subjects underwent assisted breathing after anesthesia induction, monitoring the concentration of end-expiratory carbon dioxide, and conducting electrical stimulation when the consciousness index reached the corresponding level,and the electrode position is bilateral temporal area. The main outcome measure is EEG seizure duration ,and the secondary outcome measures include average Seizure Energy Index(SEI), electric shock stimulation energy, post-seizure inhibition index, the fastest heart rate, Hamilton Depression Scale (HAMD-24) score, Montreal Cognitive Assessment Scale (MoCA) score, adverse reactions during awakening and the interval between anesthesia induction and the start of electrical stimulation.
Due to the varying frequency of electroconvulsive therapy performed by each subject, with an average of 6-12 times and varying duration of each electroconvulsive treatment, this study uses a mixed effects model to analyze the relationship between different consciousness indices and patient factors on the duration of EEG seizures. The depression score and cognitive function score before and after the complete course of electric shock are compared between groups using LSD-t test.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Zhao B shu, MM
- Phone Number: +8615823079815
- Email: bangshuzhao@163.com
Study Locations
-
-
Chongqing
-
Chongqing, Chongqing, China, 400016
- Recruiting
- The First Affiliated Hospital of Chongqing Medical University
-
Contact:
- Zhao B shu, MD
- Phone Number: +8615823079815
- Email: bangshuzhao@163.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- In-patients who meet the diagnostic criteria of moderate and severe depression in the 11th edition of the International Classification of Diseases (ICD-11)
- Age 18-60 years old, gender unlimited
- Primary school or above education level
- Indications for MECT treatment
- Normal hearing and vision (including color discrimination)
- The patient voluntarily participated in the study and signed the informed consent form, and the guardian also signed the informed consent form.
Exclusion Criteria:
- History of physical disease, brain organic disease and abuse of alcohol and psychoactive substances
- Patients with bipolar disorder
- Primary insomnia
- Combined with other mental diseases
- Combined with obesity, diabetes and other metabolic diseases
- Combined with hypertension, cardiovascular disease or cerebrovascular disease
- Combined with Alzheimer's disease
- Pregnant and lactating women.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Group H:IoC1 60-70
This study used an EEG bispectral index monitor (Apolo 9000A) to monitor consciousness index 1 (IoC1) and consciousness index 2 (IoC2) before electric shock, and then induced anesthesia with propofol 1.5mg/kg and succinylcholine 1mg/kg, following by mask pressurized oxygen supply,dental pads protect the tongue and monitoring the concentration of end-expiratory carbon dioxide.
Electrical stimulation is performed when the consciousness index 1 is between 60 and 70.
The electrode is located on the bilateral temporal side;Electric shock equipment:ThymatronSystem Ⅳ Electroconvulsive System,manufacturer:SOMATICS, USA;Propofol manufacturer: AstraZeneca of the UK, concentration: 10mg/ml.
Succinylcholine manufacturer: Shanghai Xudong Haipu Pharmaceutical Co., Ltd.China, concentration: 2ml: 0.1g.
|
EEG monitoring is performed before induction of electrical shock anesthesia(propofol1.5mg/kg+Succinylcholine1mg/kg), and the timing of electrical stimulation is determined based on the level of consciousness index 1 displayed on the EEG.
|
Active Comparator: Group M: IoC1 50-60
This study used an EEG bispectral index monitor (Apolo 9000A) to monitor consciousness index 1 (IoC1) and consciousness index 2 (IoC2) before electric shock, and then induced anesthesia with propofol 1.5mg/kg and succinylcholine 1mg/kg, following by mask pressurized oxygen supply,dental pads protect the tongue and monitoring the concentration of end-expiratory carbon dioxide.
Electrical stimulation is performed when the consciousness index 1 is between 50 and 60.
The electrode is located on the bilateral temporal side;Electric shock equipment:ThymatronSystem Ⅳ Electroconvulsive System,manufacturer:SOMATICS, USA;Propofol manufacturer: AstraZeneca of the UK, concentration: 10mg/ml.
Succinylcholine manufacturer: Shanghai Xudong Haipu Pharmaceutical Co., Ltd.China, concentration: 2ml: 0.1g.
|
EEG monitoring is performed before induction of electrical shock anesthesia(propofol1.5mg/kg+Succinylcholine1mg/kg), and the timing of electrical stimulation is determined based on the level of consciousness index 1 displayed on the EEG.
|
Active Comparator: Group L:IoC1 40-50
This study used an EEG bispectral index monitor (Apolo 9000A) to monitor consciousness index 1 (IoC1) and consciousness index 2 (IoC2) before electric shock, and then induced anesthesia with propofol 1.5mg/kg and succinylcholine 1mg/kg, following by mask pressurized oxygen supply,dental pads protect the tongue and monitoring the concentration of end-expiratory carbon dioxide.
Electrical stimulation is performed when the consciousness index 1 is between 40 and 50.
The electrode is located on the bilateral temporal side;Electric shock equipment:ThymatronSystem Ⅳ Electroconvulsive System,manufacturer:SOMATICS, USA;Propofol manufacturer: AstraZeneca of the UK, concentration: 10mg/ml.
Succinylcholine manufacturer: Shanghai Xudong Haipu Pharmaceutical Co., Ltd.China, concentration: 2ml: 0.1g.
|
EEG monitoring is performed before induction of electrical shock anesthesia(propofol1.5mg/kg+Succinylcholine1mg/kg), and the timing of electrical stimulation is determined based on the level of consciousness index 1 displayed on the EEG.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
EEG seizure duration
Time Frame: up to 30 minutes after each electroconvulsive treatment
|
Duration of EEG convulsions, in seconds,the most important index of the quality of EEG during the treatment of electric shock
|
up to 30 minutes after each electroconvulsive treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
average Seizure Energy Index(SEI)
Time Frame: up to 30 minutes after each electroconvulsive treatment
|
Indicator of quality of convulsive, in uV2
|
up to 30 minutes after each electroconvulsive treatment
|
electric shock stimulation energy
Time Frame: up to 30 minutes after each electroconvulsive treatment
|
Indicator of electric shock stimulation energy, in mC
|
up to 30 minutes after each electroconvulsive treatment
|
post-seizure inhibition index
Time Frame: up to 30 minutes after each electroconvulsive treatment
|
Indicator of quality of convulsive, in %
|
up to 30 minutes after each electroconvulsive treatment
|
Bispectral EEG monitoring index
Time Frame: up to 30 minutes after each electroconvulsive treatment
|
Depth of sedation and injury stress index,Value range 0-100
|
up to 30 minutes after each electroconvulsive treatment
|
Maximun heart rate
Time Frame: up to 30 minutes after each electroconvulsive treatment
|
Maximum heart rate during electrical stimulation,in times/minute
|
up to 30 minutes after each electroconvulsive treatment
|
Hamilton score
Time Frame: through study completion, an average of 1 year
|
Depression score,A total score of 81 points, ≤ 8 points without depression, 8-20 points with possible depression, 20-35 points with mild to moderate depression, ≥ 35 points with severe depression
|
through study completion, an average of 1 year
|
Montreal cognitive score
Time Frame: through study completion, an average of 1 year
|
cognitive function assessment,A total score of 30 points,<26 points determines the presence of cognitive impairment
|
through study completion, an average of 1 year
|
Recovery period restlessness
Time Frame: up to 4 hours after each electroconvulsive treatment
|
Complications during anesthesia recovery,Using Richmond restless sedation scale
|
up to 4 hours after each electroconvulsive treatment
|
Recovery period delirium
Time Frame: up to 4 hours after each electroconvulsive treatment
|
Complications during anesthesia recovery,Using CAM-ICU scale
|
up to 4 hours after each electroconvulsive treatment
|
Recovery period nausea and vomiting
Time Frame: up to 4 hours after each electroconvulsive treatment
|
Complications during anesthesia recovery,Using index of nausea and vomiting and retching(R-INVR)
|
up to 4 hours after each electroconvulsive treatment
|
Recovery period muscle soreness, headache, dizziness
Time Frame: up to 4 hours after each electroconvulsive treatment
|
Complications during anesthesia recovery,Using 0 for none, 1 for yes
|
up to 4 hours after each electroconvulsive treatment
|
interval between anesthesia induction and the start of electrical stimulation
Time Frame: up to 4 hours after each electroconvulsive treatment
|
Time to wait for electrical stimulation after administration,in seconds
|
up to 4 hours after each electroconvulsive treatment
|
intraoperative awareness
Time Frame: up to 4 hours after each electroconvulsive treatment
|
During general anesthesia, consciousness recovery occurs, and the patient has a certain degree of perception and memory of the surrounding environment or sound.
After general anesthesia, the patient can recall what happened during the surgery and be informed of any pain or other conditions.
Events occurring before induction to sleep and after awakening from anesthesia were not included.
|
up to 4 hours after each electroconvulsive treatment
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Min Su, BM, First Affiliated Hospital of Chongqing Medical University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Mental Disorders
- Nervous System Diseases
- Mood Disorders
- Neurologic Manifestations
- Depression
- Depressive Disorder
- Seizures
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Anesthetics, Intravenous
- Anesthetics, General
- Hypnotics and Sedatives
- Neuromuscular Agents
- Neuromuscular Blocking Agents
- Neuromuscular Depolarizing Agents
- Anesthetics
- Propofol
- Succinylcholine
Other Study ID Numbers
- CQMUFH-2023-052
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Depression
-
ProgenaBiomeRecruitingDepression | Depression, Postpartum | Depression, Anxiety | Depression Moderate | Depression Severe | Clinical Depression | Depression in Remission | Depression, Endogenous | Depression ChronicUnited States
-
Washington University School of MedicineCompletedTreatment Resistant Depression | Late Life Depression | Geriatric Depression | Refractory Depression | Therapy-Resistant DepressionUnited States, Canada
-
Kintsugi Mindful Wellness, Inc.Sonar Strategies; Vituity PsychiatryRecruitingDepression | Depression Moderate | Depression Severe | Depression MildUnited States
-
University of California, San FranciscoRecruitingDepression Moderate | Depression Mild | Depression, TeenUnited States
-
University GhentUniversiteit Antwerpen; Janssen-Cilag Ltd.RecruitingDepression Moderate | Depression Severe | Depression MildBelgium
-
Baylor College of MedicineUniversity of TexasRecruitingDepression | Depression Moderate | Depression Severe | Suicide and Self-harm | Depression in Adolescence | Depression MildUnited States
-
University of Cape TownNational Institute of Mental Health (NIMH)CompletedPostpartum Depression | Clinical Depression | Moderate DepressionSouth Africa
-
Washington University School of MedicinePatient-Centered Outcomes Research Institute; National Institute of Mental...CompletedMajor Depressive Disorder | Treatment Resistant Depression | Treatment-Refractory Depression | Late Life Depression | Geriatric DepressionUnited States, Canada
-
Northern Illinois UniversityUniversity Autonoma de Santo DomingoTerminatedDepression Moderate | Depression MildUnited States, Dominican Republic
-
Lawson Health Research InstituteTerminated
Clinical Trials on Index of consciousness+Anesthetic(propofol)+Muscle relaxant(Succinylcholine)
-
University of California, San FranciscoMerck Sharp & Dohme LLCCompletedNeuromuscular BlockadeUnited States
-
Universitaire Ziekenhuizen KU LeuvenVU University of AmsterdamCompleted
-
Tanta UniversityEnrolling by invitationPain, Postoperative | Hip DysplasiaEgypt
-
Johns Hopkins UniversityMercy Medical CenterCompletedDelirium | Lumbar Radiculopathy | Lumbar Osteoarthritis | Lumbar Spine Disc DegenerationUnited States
-
Mansoura UniversityCompletedElective Major Abdominal SurgeryEgypt
-
Muhammad Magdy GaberCairo UniversityCompletedCerebellopontine Angle TumorEgypt
-
Massachusetts General HospitalTerminatedMajor Depressive DisorderUnited States
-
Tanta UniversityNot yet recruitingAnalgesia | Lumbar Spine Disease
-
Tanta UniversityNot yet recruitingPostoperative Pain | Inguinal Hernia | Caudal Block | Quadratus Lumborum Block | Transversus Abdominis Plane Block
-
Second Affiliated Hospital, School of Medicine,...Fudan University; Peking Union Medical College Hospital; West China Hospital; The... and other collaboratorsRecruitingAcute Respiratory Distress SyndromeChina