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

Depression Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05900245
• Other study ID #: CQMUFH-2023-052
• Status: Recruiting
• Phase: N/A
• Start date: June 12, 2023
• Est. completion date: August 31, 2024

Study information

• Verified date: January 2024
• Source: First Affiliated Hospital of Chongqing Medical University
• Contact: Zhao B shu, MM
• Phone: +8615823079815
• Email: bangshuzhao[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: August 31, 2024
• Est. primary completion date: March 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Electroconvulsive Therapy
• Electroencephalography
• Seizures

Intervention

Other:
• Index of consciousness+Anesthetic(propofol)+Muscle relaxant(Succinylcholine)
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.

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Chongqing Medical University	Chongqing	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
Min Su

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	EEG seizure duration	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	average Seizure Energy Index(SEI)	Indicator of quality of convulsive, in uV2	up to 30 minutes after each electroconvulsive treatment
Secondary	electric shock stimulation energy	Indicator of electric shock stimulation energy, in mC	up to 30 minutes after each electroconvulsive treatment
Secondary	post-seizure inhibition index	Indicator of quality of convulsive, in %	up to 30 minutes after each electroconvulsive treatment
Secondary	Bispectral EEG monitoring index	Depth of sedation and injury stress index,Value range 0-100	up to 30 minutes after each electroconvulsive treatment
Secondary	Maximun heart rate	Maximum heart rate during electrical stimulation,in times/minute	up to 30 minutes after each electroconvulsive treatment
Secondary	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	through study completion, an average of 1 year
Secondary	Montreal cognitive score	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
Secondary	Recovery period restlessness	Complications during anesthesia recovery,Using Richmond restless sedation scale	up to 4 hours after each electroconvulsive treatment
Secondary	Recovery period delirium	Complications during anesthesia recovery,Using CAM-ICU scale	up to 4 hours after each electroconvulsive treatment
Secondary	Recovery period nausea and vomiting	Complications during anesthesia recovery,Using index of nausea and vomiting and retching(R-INVR)	up to 4 hours after each electroconvulsive treatment
Secondary	Recovery period muscle soreness, headache, dizziness	Complications during anesthesia recovery,Using 0 for none, 1 for yes	up to 4 hours after each electroconvulsive treatment
Secondary	interval between anesthesia induction and the start of electrical stimulation	Time to wait for electrical stimulation after administration,in seconds	up to 4 hours after each electroconvulsive treatment
Secondary	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.	up to 4 hours after each electroconvulsive treatment