UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000023708
Receipt number R000027301
Scientific Title Open lavel single center crossover study concerning the change of PVI(Pleth Variability Index) and SVV(Stroke Volume Valiance) durung mECT(modified Electro Convulsive Therapy).
Date of disclosure of the study information 2016/08/21
Last modified on 2021/03/13 21:17:02

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Basic information

Public title

Open lavel single center crossover study concerning the change of PVI(Pleth Variability Index) and SVV(Stroke Volume Valiance) durung mECT(modified Electro Convulsive Therapy).

Acronym

Prospective study concerning the change of PVI and SVV durung mECT.

Scientific Title

Open lavel single center crossover study concerning the change of PVI(Pleth Variability Index) and SVV(Stroke Volume Valiance) durung mECT(modified Electro Convulsive Therapy).

Scientific Title:Acronym

Prospective study concerning the change of PVI and SVV durung mECT.

Region

Japan


Condition

Condition

Scheduled mECT cases of ASA 1 or 2.

Classification by specialty

Psychiatry Anesthesiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Our goal in this study is to provide safer perioperative care for scheduled mECT through verification of the change of pleth variability index (PVI) and stroke volume valiance.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Others

Trial characteristics_2

Pragmatic

Developmental phase



Assessment

Primary outcomes

The difference of the change of PVI and SVV during mECT

Key secondary outcomes

1. The difference of the change of PVI during mECT (comparison between first time and second time)
2. The difference of the change of SVV during mECT(comparison between first time and second time)


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Self control

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

No need to know


Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

Patients are prohibited eating from 9 p.m.of the previous night of mECT. After entering operating room, patient is monitered ECG, NIBP, SpO2, temperature and PVI of Masimo Radical 7 and SVV of ClearSight Fiinger Cuff (Edwards). Each of data is recorded throughout operation. After control EEG measurement, propofol 1mg/kg is administered. If the patient is alert after 3 minutes of administration, additional 0.2mg/kg is administered. This process is repeated until loss of awareness. After that, thigh mounted cuff is pressurred to 250mmHg, 1mg/kg of succinylcholine is administered.
ECT is done after one minutes's hand ventilation of twenty times per minute to inspiratory pressure 15mmg after confirming the oncet and dissipation of fasciculation. After the end of ECT, hand ventilation of six times per minute to inspiratory pressure 15mmg is continued until emergence of spontaneous respiration. Data of PVI and SVV are acquired until leaving operation room time. A comparison of change of PVI and SVV of following four points are checked after that. 1.After entering operation room and before anesthsia, 2.After administration of propofol and succinylcholine (just before ECT), 3.One minute after the ECT, 4.After awakening. The second time's ECT dose of propofol and succinylcholine is set to the same as the first time's total dose. In the case of ECT is uneffective, the second time's ECT dose of propofol is set to 0.8mg/kg.

Interventions/Control_2


Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1.ASA 1or 2 of scheduled mECT
2.Weight from 45kg to 90kg
3.Fully apprehended as to purport or meaning of the study and with written consent (approved by the ethics committee) after received an explanation.

Key exclusion criteria

1.Allergic or having contraindication to any medicine used in this study
2.Peripheral vascular disorder
3.Cardiovascular disturbance, Cerebrovascular disorder
4.Neuromuscular disease
5.BMI>35
6.Renal impairment (estimated Ccr<30)

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Tomoyuki Sato

Organization

saiseikai yokohamashi tobu hospital

Division name

department of anesthesiology

Zip code


Address

3-6-1 shimosueyoshi turumi-ku yo kohama-shi kanagawa-ken

TEL

045-576-3000

Email

tomoyukisatoh@seagreen.ocn.ne.jp


Public contact

Name of contact person

1st name
Middle name
Last name Tomoyuki Sato

Organization

saiseikai yokohamashi tobu hospit al

Division name

department of anesthesiology

Zip code


Address

3-6-1 shimosueyoshi turumi-ku yo kohama-shi kanagawa-ken

TEL

045-576-3000

Homepage URL


Email

tomoyukisatoh@seagreen.ocn.ne.jp


Sponsor or person

Institute

saiseikai yokohamashi tobu hospital

Institute

Department

Personal name



Funding Source

Organization

saiseikai yokohamashi tobu hospit
al

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2016 Year 08 Month 21 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Terminated

Date of protocol fixation

2016 Year 08 Month 20 Day

Date of IRB

2016 Year 08 Month 20 Day

Anticipated trial start date

2016 Year 08 Month 21 Day

Last follow-up date

2019 Year 08 Month 31 Day

Date of closure to data entry

2019 Year 09 Month 15 Day

Date trial data considered complete

2019 Year 09 Month 30 Day

Date analysis concluded

2019 Year 10 Month 31 Day


Other

Other related information



Management information

Registered date

2016 Year 08 Month 21 Day

Last modified on

2021 Year 03 Month 13 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027301


Research Plan
Registered date File name
2017/10/05 mECT倫理提出11.20..docx

Research case data specifications
Registered date File name
2017/10/05 登録票mECT.xlsx

Research case data
Registered date File name
2017/10/05 症例報告書 m-ECT11.4..xlsx