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

Summary

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.

Conditions

• Depression
• Schizophrenia
• Bipolar Disorder
• Cognitive Dysfunction

Interventions

DEVICE

Target controlled infusion, Schnider model

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.

BEHAVIORAL

Bolus injection of Propofol

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.

Sponsors & Collaborators

• Chang Gung Memorial Hospital

  lead OTHER

Principal Investigators

• Meng Ling Hsieh · Chang Gung Memorial Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

20 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-08-15

Primary Completion

2019-02-01

Completion

2019-02-02

Countries

• Taiwan

Study Locations