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Anesthesia Induction Schemes of Electroconvulsive Convulsions in Patients With Depression Based on EEG Monitoring

Primary Purpose

Depression, Electroconvulsive Therapy, Electroencephalography

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Index of consciousness+Anesthetic(propofol)+Muscle relaxant(Succinylcholine)
Sponsored by
Min Su
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Depression focused on measuring Depression,Electroconvulsive Therapy,Electroencephalography

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The First Affiliated Hospital of Chongqing Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Group H:IoC1 60-70

Group M: IoC1 50-60

Group L:IoC1 40-50

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

EEG seizure duration
Duration of EEG convulsions, in seconds,the most important index of the quality of EEG during the treatment of electric shock

Secondary Outcome Measures

average Seizure Energy Index(SEI)
Indicator of quality of convulsive, in uV2
electric shock stimulation energy
Indicator of electric shock stimulation energy, in mC
post-seizure inhibition index
Indicator of quality of convulsive, in %
Bispectral EEG monitoring index
Depth of sedation and injury stress index,Value range 0-100
Maximun heart rate
Maximum heart rate during electrical stimulation,in times/minute
Hamilton score
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
Montreal cognitive score
cognitive function assessment,A total score of 30 points,<26 points determines the presence of cognitive impairment
Recovery period restlessness
Complications during anesthesia recovery,Using Richmond restless sedation scale
Recovery period delirium
Complications during anesthesia recovery,Using CAM-ICU scale
Recovery period nausea and vomiting
Complications during anesthesia recovery,Using index of nausea and vomiting and retching(R-INVR)
Recovery period muscle soreness, headache, dizziness
Complications during anesthesia recovery,Using 0 for none, 1 for yes
interval between anesthesia induction and the start of electrical stimulation
Time to wait for electrical stimulation after administration,in seconds
intraoperative awareness
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.

Full Information

First Posted
March 9, 2023
Last Updated
October 12, 2023
Sponsor
Min Su
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1. Study Identification

Unique Protocol Identification Number
NCT05900245
Brief Title
Anesthesia Induction Schemes of Electroconvulsive Convulsions in Patients With Depression Based on EEG Monitoring
Official Title
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 Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 12, 2023 (Actual)
Primary Completion Date
October 12, 2023 (Anticipated)
Study Completion Date
August 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Min Su

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Depression is a common clinical mental disease with high incidence rate, high recurrence rate, high suicide rate and high disability rate. As a first-line treatment for depression with refractory, high suicide risk and obvious psychotic symptoms, electric shock has a definite effect on depression, but may lead to cognitive impairment. The induction of extensive epileptiform discharges in the cerebral cortex by electric shock therapy is the key to ensure the treatment effect. The level of epileptiform discharges in the brain is mainly reflected in the quality of convulsions. The quality of electroconvulsive convulsions is affected by factors such as age, stimulation power, anesthetic drugs and depth of anesthesia. Most anesthetics have anticonvulsive properties, such as barbiturate or propofol, which may have a negative impact on the quality of convulsions, thus affecting the therapeutic effect. If the parameters of electric shock, such as stimulation dose, are modified, although the quality and treatment effect of convulsions can be improved, it may also lead to higher cognitive side effects. The depth of anesthesia also affects the quality and efficacy of electric shock convulsions, and the quality of convulsions is higher when stimulated at a shallow level of anesthesia. However, if the use of narcotic drugs is reduced to improve the quality of convulsions, the risk of restlessness and delirium after electric shock may be higher and the comfort of patients may be lower. Therefore, this study compared the effects of different anesthesia induction schemes on the quality and clinical efficacy of electroconvulsive seizures in patients with depression based on EEG monitoring, and explored the optimal depth of anesthesia.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Electroconvulsive Therapy, Electroencephalography
Keywords
Depression,Electroconvulsive Therapy,Electroencephalography

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
Due to the fact that anesthesiologists need to determine the timing of electrical stimulation based on the level of consciousness index during the treatment of electric shock, this study is a randomized controlled, single blind study.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.
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
Due to the fact that anesthesiologists need to determine the timing of electrical stimulation based on the level of consciousness index during the treatment of electric shock, this study is a randomized controlled, single blind study. The subjects were not aware of their grouping, consciousness index level, and the anesthesiologist was aware of the subjects' consciousness index level, but did not participate in data analysis. The data analyst is not clear about the specific content of the grouping.
Allocation
Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group H:IoC1 60-70
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Group M: IoC1 50-60
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Group L:IoC1 40-50
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Index of consciousness+Anesthetic(propofol)+Muscle relaxant(Succinylcholine)
Intervention Description
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.
Primary Outcome Measure Information:
Title
EEG seizure duration
Description
Duration of EEG convulsions, in seconds,the most important index of the quality of EEG during the treatment of electric shock
Time Frame
up to 30 minutes after each electroconvulsive treatment
Secondary Outcome Measure Information:
Title
average Seizure Energy Index(SEI)
Description
Indicator of quality of convulsive, in uV2
Time Frame
up to 30 minutes after each electroconvulsive treatment
Title
electric shock stimulation energy
Description
Indicator of electric shock stimulation energy, in mC
Time Frame
up to 30 minutes after each electroconvulsive treatment
Title
post-seizure inhibition index
Description
Indicator of quality of convulsive, in %
Time Frame
up to 30 minutes after each electroconvulsive treatment
Title
Bispectral EEG monitoring index
Description
Depth of sedation and injury stress index,Value range 0-100
Time Frame
up to 30 minutes after each electroconvulsive treatment
Title
Maximun heart rate
Description
Maximum heart rate during electrical stimulation,in times/minute
Time Frame
up to 30 minutes after each electroconvulsive treatment
Title
Hamilton score
Description
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
Time Frame
through study completion, an average of 1 year
Title
Montreal cognitive score
Description
cognitive function assessment,A total score of 30 points,<26 points determines the presence of cognitive impairment
Time Frame
through study completion, an average of 1 year
Title
Recovery period restlessness
Description
Complications during anesthesia recovery,Using Richmond restless sedation scale
Time Frame
up to 4 hours after each electroconvulsive treatment
Title
Recovery period delirium
Description
Complications during anesthesia recovery,Using CAM-ICU scale
Time Frame
up to 4 hours after each electroconvulsive treatment
Title
Recovery period nausea and vomiting
Description
Complications during anesthesia recovery,Using index of nausea and vomiting and retching(R-INVR)
Time Frame
up to 4 hours after each electroconvulsive treatment
Title
Recovery period muscle soreness, headache, dizziness
Description
Complications during anesthesia recovery,Using 0 for none, 1 for yes
Time Frame
up to 4 hours after each electroconvulsive treatment
Title
interval between anesthesia induction and the start of electrical stimulation
Description
Time to wait for electrical stimulation after administration,in seconds
Time Frame
up to 4 hours after each electroconvulsive treatment
Title
intraoperative awareness
Description
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.
Time Frame
up to 4 hours after each electroconvulsive treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhao B shu, MM
Phone
+8615823079815
Email
bangshuzhao@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Min Su, BM
Organizational Affiliation
First Affiliated Hospital of Chongqing Medical University
Official's Role
Study Director
Facility Information:
Facility Name
The First Affiliated Hospital of Chongqing Medical University
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400016
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhao B shu, MD
Phone
+8615823079815
Email
bangshuzhao@163.com

12. IPD Sharing Statement

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Anesthesia Induction Schemes of Electroconvulsive Convulsions in Patients With Depression Based on EEG Monitoring

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