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
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
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
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 |
Single case data URL
Value
https://center6.umin.ac.jp/ice/27301
