Comparison of Propofol Target-Controlled Infusion Anesthesia and Bolus Injection in Electroconvulsive Therapy
Condition: Depression; Schizophrenia; Bipolar Disorder; Cognitive Dysfunction
MeSH terms: Schizophrenia; Bipolar Disorder; Cognitive Dysfunction
Study type: Interventional
Phase: Phase 4

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.
    

Detailed description: 
      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.
    

Intervention name(s): Target controlled infusion, Schnider model; Bolus injection of Propofol
Intervention type(s): Device; Behavioral
Intervention description(s): 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 intravenous injection is a traditional way to deliver anesthetic, and the dosage and amount of medication is based on clinical experience and patients' response.
Intervention MeSH terms: Propofol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: Electroconvulsive therapy; Propofol; Target controlled infusion