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Completed

NCT Number: NCT03863925

Comparison of Propofol Target-Controlled Infusion Anesthesia and Bolus Injection in Electroconvulsive Therapy

Electroconvulsive therapy (ECT) serves as an effective adjuvant or alternative modality for major depressive disorder, schizophrenia, or bipolar affective disorder refractory to or contraindicated to psychopharmacological treatment. Anesthetics have been introduced into ECT sessions to alleviate ECT-inducing discomfort sensation, tachycardia, arrhythmia, hypertension, and anxiety. Propofol is highly lipid soluble and able to rapidly cross the blood-brain barrier (BBB), which leads to rapid onset of sedation and hypnosis. Meanwhile, propofol has hemodynamic depressant effect and attenuates hypertensive surge during ECT. Characteristics mentioned above make propofol one of widely used anesthetics for anesthetized ECT.

Propofol can be administered with bolus injection or target-controlled infusion (TCI). Compared with bolus injection, TCI provides relatively constant concentration at site of interest based on computer simulation with input of pharmacokinetic parameters, such as age, body weight, body height, etc. However, propofol is also well known for anticonvulsant property, which may inevitably interfere with seizure propagation by electroconvulsive stimulus and diminish consequent efficacy. Thus, dosage of electrical stimulus may be increased to achieve ideal seizure quality in this setting, which also leads to higher risk of subsequent cognitive impairment.

In our clinical practice, TCI system reduces total amount of propofol in comparison with bolus injection method. Therefore, we hypothesize that application of TCI system in anesthetized ECT relates to lower dosage of electrical stimulus and decreased incidence or severity of post-treatment cognitive impairment.

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Key information

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Chang Gung Memorial Hospital

Taoyuan City, 33305, Taiwan

About this study

Electroconvulsive therapy (ECT) serves as an effective adjuvant or alternative modality for major depressive disorder, schizophrenia, or bipolar affective disorder refractory to or contraindicated to psychopharmacological treatment. Anesthetics have been introduced into ECT sessions to alleviate ECT-inducing discomfort sensation, tachycardia, arrhythmia, hypertension, and anxiety. Propofol is highly lipid soluble and able to rapidly cross the blood-brain barrier (BBB), which leads to rapid onset of sedation and hypnosis. Meanwhile, propofol has hemodynamic depressant effect and attenuates hypertensive surge during ECT. Characteristics mentioned above make propofol one of widely used anesthetics for anesthetized ECT.

Propofol can be administered with bolus injection or target-controlled infusion (TCI). Compared with bolus injection, TCI provides relatively constant concentration at site of interest based on computer simulation with input of pharmacokinetic parameters, such as age, body weight, body height, etc. However, propofol is also well known for anticonvulsant property, which may inevitably interfere with seizure propagation by electroconvulsive stimulus and diminish consequent efficacy. Thus, dosage of electrical stimulus may be increased to achieve ideal seizure quality in this setting, which also leads to higher risk of subsequent cognitive impairment.

In our clinical practice, TCI system reduces total amount of propofol in comparison with bolus injection method. Therefore, we hypothesize that application of TCI system in anesthetized ECT relates to lower dosage of electrical stimulus and decreased incidence or severity of post-treatment cognitive impairment.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age between 20 years old and 65 years old
  • Diagnosis of major depressive disorder, bipolar disorder, and schizophrenia, compatible with SCID for DSM-5, with clinical necessity of ECT under a psychiatrist's evaluation and decision
  • Patients with adequate visual acuity and auditory acuity without or with correction
  • Patients or patients' legal representative signing up the informed consent

Exclusion criteria

  • Patients already diagnosed with neurocognitive disorder
  • Patients with contraindications to ECT, including myocardial infarction, cerebrovascular disease, elevated intracranial pressure, intracranial angiomas, untreated bony fractures, cervical spine injury, pheochromocytoma, heart failure, sever valvular disease, deep vein thrombosis, etc.
  • Patients with untreated substance abuse, including alcohol and illegal drugs
  • Patients with unspecified psychiatric disorders
  • Patients unable to cooperate

Treatment and study plan

Target controlled infusion, Schnider model

Device

Target controlled infusion (TCI) is an intravenous drug delivery system estimating pharmacokinetics after input of patient's data, e.g. age, sex, body height, body weight. Schnider model is one of TCI model to deliver Propofol. After target concentration at effect site (e.g. the brain) is keyed in, the computerized infusion pump will calculate dosage of bolus and infusion rate for each individual, and calculated concentration of propofol at plasma and brain will be displayed. The clinicians should evaluate the patient's sedation level in response to calculated propofol concentration and titrate target concentration to achieve desired sedation level.

Bolus injection of Propofol

Behavioral

Bolus intravenous injection is a traditional way to deliver anesthetic, and the dosage and amount of medication is based on clinical experience and patients' response.

Primary outcomes

  1. Change from baseline Clinical Global Impression-Severity (CGI-S)

    Time frame: through study completion, an average of one month

    Evaluation with Clinical Global Impression-Severity (CGI-S)

  2. Change from baseline Clinical Global Impression-Improvement (CGI-I)

    Time frame: through study completion, an average of one month

    Evaluation with Clinical Global Impression-Improvement (CGI-I)

Secondary outcomes

  1. Cognitive dysfunction

    Time frame: through study completion, an average of one month

    Evaluation with Montreal Cognitive Assessment (MoCA)

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Official study title

Comparison of Propofol Target-Controlled Infusion Anesthesia and Bolus Injection in Electroconvulsive Therapy: A Randomized Controlled Trial

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Mar 5, 2019
Registry last updated
Mar 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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