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

Primary Purpose

Depression, Schizophrenia, Bipolar Disorder

Status
Completed
Phase
Phase 4
Locations
Taiwan
Study Type
Interventional
Intervention
Target controlled infusion, Schnider model
Bolus injection of Propofol
Sponsored by
Chang Gung Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring Electroconvulsive therapy, Propofol, Target controlled infusion

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Chang Gung Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Propofol Target Controlled Infusion Group (Group T)

Propofol Bolus Group (Group B)

Arm Description

Patients in group T underwent anesthesia with Propofol (dosage form: 10mg/mL) target controlled infusion by Schnider model, starting at concentration of effect site (Ce) of 1.5 mcg/mL and titrating to achieve Observer's Assessment of Alertness/Sedation (OAA/S) Scale level 3 (responds only after name called loudly or repeatedly). Patients were paralyzed with suxamethonium (dosage form: 20mg/mL; dosage: 1mg/kg) once adequate sedation level achieved. TCI was stopped once the psychiatrist applied electroconvulsive stimulation to patients' bilateral frontal regions. Assisted ventilation with bag-valve-mask device by experienced anesthesiologists was began since patients were sedated until adequate spontaneous respiration was regained after each single electroconvulsive therapy (ECT) session. Every patient receive total six to twelve ECT sessions, and each ECT session was conducted one day apart.

Patients in group B underwent anesthesia with bolus of propofol for sedation, and the dosage raged between 0.75 to 1.5 mg/kg to achieve at least OAA/S scale level 3. Dosage of suxamethonium, application of electroconvulsive stimulation, ventilation maneuver, frequency of ECT session, and number of total ECT sessions were same as patients in group T.

Outcomes

Primary Outcome Measures

Change from baseline Clinical Global Impression-Severity (CGI-S)
Evaluation with Clinical Global Impression-Severity (CGI-S)
Change from baseline Clinical Global Impression-Improvement (CGI-I)
Evaluation with Clinical Global Impression-Improvement (CGI-I)

Secondary Outcome Measures

Cognitive dysfunction
Evaluation with Montreal Cognitive Assessment (MoCA)

Full Information

First Posted
February 25, 2019
Last Updated
March 3, 2019
Sponsor
Chang Gung Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03863925
Brief Title
Comparison of Propofol Target-Controlled Infusion Anesthesia and Bolus Injection in Electroconvulsive Therapy
Official Title
Comparison of Propofol Target-Controlled Infusion Anesthesia and Bolus Injection in Electroconvulsive Therapy: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
August 15, 2017 (Actual)
Primary Completion Date
February 1, 2019 (Actual)
Study Completion Date
February 2, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chang Gung Memorial Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Schizophrenia, Bipolar Disorder, Cognitive Dysfunction
Keywords
Electroconvulsive therapy, Propofol, Target controlled infusion

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Propofol Target Controlled Infusion Group (Group T)
Arm Type
Experimental
Arm Description
Patients in group T underwent anesthesia with Propofol (dosage form: 10mg/mL) target controlled infusion by Schnider model, starting at concentration of effect site (Ce) of 1.5 mcg/mL and titrating to achieve Observer's Assessment of Alertness/Sedation (OAA/S) Scale level 3 (responds only after name called loudly or repeatedly). Patients were paralyzed with suxamethonium (dosage form: 20mg/mL; dosage: 1mg/kg) once adequate sedation level achieved. TCI was stopped once the psychiatrist applied electroconvulsive stimulation to patients' bilateral frontal regions. Assisted ventilation with bag-valve-mask device by experienced anesthesiologists was began since patients were sedated until adequate spontaneous respiration was regained after each single electroconvulsive therapy (ECT) session. Every patient receive total six to twelve ECT sessions, and each ECT session was conducted one day apart.
Arm Title
Propofol Bolus Group (Group B)
Arm Type
Active Comparator
Arm Description
Patients in group B underwent anesthesia with bolus of propofol for sedation, and the dosage raged between 0.75 to 1.5 mg/kg to achieve at least OAA/S scale level 3. Dosage of suxamethonium, application of electroconvulsive stimulation, ventilation maneuver, frequency of ECT session, and number of total ECT sessions were same as patients in group T.
Intervention Type
Device
Intervention Name(s)
Target controlled infusion, Schnider model
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Bolus injection of Propofol
Intervention Description
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 Outcome Measure Information:
Title
Change from baseline Clinical Global Impression-Severity (CGI-S)
Description
Evaluation with Clinical Global Impression-Severity (CGI-S)
Time Frame
through study completion, an average of one month
Title
Change from baseline Clinical Global Impression-Improvement (CGI-I)
Description
Evaluation with Clinical Global Impression-Improvement (CGI-I)
Time Frame
through study completion, an average of one month
Secondary Outcome Measure Information:
Title
Cognitive dysfunction
Description
Evaluation with Montreal Cognitive Assessment (MoCA)
Time Frame
through study completion, an average of one month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Meng Ling Hsieh
Organizational Affiliation
Chang Gung Memorial Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chang Gung Memorial Hospital
City
Taoyuan City
ZIP/Postal Code
33305
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
20673880
Citation
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Results Reference
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Citation
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Results Reference
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PubMed Identifier
15817019
Citation
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Results Reference
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PubMed Identifier
10687746
Citation
Sakamoto A, Hoshino T, Suzuki N, Suzuki H, Kimura M, Ogawa R. Effects of propofol anesthesia on cognitive recovery of patients undergoing electroconvulsive therapy. Psychiatry Clin Neurosci. 1999 Dec;53(6):655-60. doi: 10.1046/j.1440-1819.1999.00621.x.
Results Reference
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Citation
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Results Reference
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PubMed Identifier
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Citation
Galvez V, Hadzi-Pavlovic D, Wark H, Harper S, Leyden J, Loo CK. The Anaesthetic-ECT Time Interval in Electroconvulsive Therapy Practice--Is It Time to Time? Brain Stimul. 2016 Jan-Feb;9(1):72-7. doi: 10.1016/j.brs.2015.09.005. Epub 2015 Sep 12.
Results Reference
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Citation
Hsieh ML, Lu YT, Lin CC, Lee CP. Comparison of the target-controlled infusion and the manual infusion of propofol anesthesia during electroconvulsive therapy: an open-label randomized controlled trial. BMC Psychiatry. 2021 Feb 4;21(1):71. doi: 10.1186/s12888-021-03069-6.
Results Reference
derived

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

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