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

NCT05900245 | Unknown

• 1 other identifier: CQMUFH-2023-052
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression; Electroconvulsive Therapy; Electroencephalography

Keywords

Depression,Electroconvulsive Therapy,Electroencephalography

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• average Seizure Energy Index(SEI)

  up to 30 minutes after each electroconvulsive treatment

• electric shock stimulation energy

  up to 30 minutes after each electroconvulsive treatment

• post-seizure inhibition index

  up to 30 minutes after each electroconvulsive treatment

• Bispectral EEG monitoring index

  up to 30 minutes after each electroconvulsive treatment

• Maximun heart rate

  up to 30 minutes after each electroconvulsive treatment

Study Arms (3)

Group H：IoC1 60-70

ACTIVE COMPARATOR

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.

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

Group M: IoC1 50-60

ACTIVE COMPARATOR

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.

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

Group L：IoC1 40-50

ACTIVE COMPARATOR

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.

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

Interventions

Index of consciousness+Anesthetic（propofol）+Muscle relaxant（Succinylcholine） OTHER

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.

Group H：IoC1 60-70; Group L：IoC1 40-50; Group M: IoC1 50-60

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Min Su: lead

Study Sites (1)

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400016, China

RECRUITING

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Min Su, BM

  First Affiliated Hospital of Chongqing Medical University

  STUDY DIRECTOR

Central Study Contacts

Zhao B shu, MM

CONTACT

+8615823079815; bangshuzhao@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Anesthesiology

Model Details: 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.

Study Record Dates

• First Submitted: March 9, 2023
• First Posted: June 12, 2023
• Study Start: June 12, 2023
• Primary Completion: March 31, 2024
• Study Completion: August 31, 2024
• Last Updated: January 26, 2024

Record last verified: 2024-01

Locations

CN (1)