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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000033178
Receipt No. R000037836
Official scientific title of the study Evaluation of surgical condition during Interventional Neuroradiology (INR) in patients with deep vs moderate neuromuscular block
Date of disclosure of the study information 2018/07/06
Last modified on 2018/07/05

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Basic information
Official scientific title of the study Evaluation of surgical condition during Interventional Neuroradiology (INR) in patients with deep vs moderate neuromuscular block
Title of the study (Brief title) Evaluation of surgical condition during Interventional Neuroradiology (INR) in patients with deep vs moderate neuromuscular block
Region
Asia(except Japan)

Condition
Condition Randomized controlled observational study
Classification by specialty
Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 surgical condition
Basic objectives2 Others
Basic objectives -Others recovery time, hemodynamic change
Trial characteristics_1 Others
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes surgical condition rating by surgeon
Key secondary outcomes recovery time, hemodynamic change

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Dose comparison
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 In the course of performing interventional procedures of cerebrovascular disease under general anesthesia, one of two methods of using muscle relaxant is selected randomly.

1. deep neuromuscular block


The degree of muscle relaxation during surgery was continuously monitored by TOF-Watch SX, a muscle relaxation monitor attached to the patient's ulnar nerve, and maintained a deep muscle relaxation state, PTC count 1-2, in the experimental group.

A. TOF count of 3 or more: Rocuronium 0.15 mg / kg is administered in both experimental and control groups.
B. TOF count is 1 or 2: rocuronium 0.15 mg / kg is administered in the experimental group. Control group is observed.
C. TOF count is 0: PTC count is measured in the experimental group. Control group is observed. And, PTC count 0,1,2: Observe the experimental group. Or PTC count 3 or more: Administer rocuronium 0.15 mg / kg in the experimental group.
D. TOF count monitoring should be maintained continuously at intervals of 12 seconds.
Interventions/Control_2 In the course of performing interventional procedures of cerebrovascular disease under general anesthesia, one of two methods of using muscle relaxant is selected randomly.

2. moderate neuromuscular block


The degree of muscle relaxation during surgery was continuously monitored by TOF-Watch SX, a muscle relaxation monitor attached to the patient's ulnar nerve, and maintained a deep muscle relaxation state, PTC count 1-2, in the experimental group.

A. TOF count of 3 or more: Rocuronium 0.15 mg / kg is administered in both experimental and control groups.
B. TOF count is 1 or 2: rocuronium 0.15 mg / kg is administered in the experimental group. Control group is observed.
C. TOF count is 0: PTC count is measured in the experimental group. Control group is observed. And, PTC count 0,1,2: Observe the experimental group. Or PTC count 3 or more: Administer rocuronium 0.15 mg / kg in the experimental group.
D. TOF count monitoring should be maintained continuously at intervals of 12 seconds.
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
19 years-old <=
Age-upper limit
65 years-old >=
Gender Male and Female
Key inclusion criteria The American Society of Anesthesiologists (ASA) Class I and II patients who were admitted to our institution to undergo regular surgery were enrolled in this study.
Key exclusion criteria 1. American Academy of Anesthesiology ASA physical classification 3 or 4
2. Patients with a history of myasthenia gravis
3. Patients with renal impairment: serum creatinine more than 2 times normal, urine volume <0.5 ml / kg / hr, GFR <60 ml / hr, with proteinuria
4. Patients with allergy to rocuronium
5. Patients with a history of malignant hypertension
6. 18.5 kg / m2 <BMI <30 kg / m2 does not fall into this category
7. Patients who refuse to participate in the study or can not receive informed consent
Target sample size 58

Research contact person
Name of lead principal investigator Jin Hee Kim
Organization Seoul National University Bundang Hospital
Division name Department of Anesthesiology and Pain Medicine
Address 82 Gumi-ro, 173 Beon-gil, Bundang-gu, Seongnam, Gyeonggi-do, Republic of Korea
TEL 82-31-787-7499
Email 89583@snubh.org

Public contact
Name of contact person Bo Young Kim
Organization Seoul National University Bundang Hospital
Division name Department of Anesthesiology and Pain Medicine
Address 82 Gumi-ro, 173 Beon-gil, Bundang-gu, Seongnam, Gyeonggi-do, Republic of Korea
TEL 82-31-787-7499
Homepage URL
Email notinvasive@gmail.com

Sponsor
Institute Seoul National University Bundang Hospital
Institute
Department

Funding Source
Organization Seoul National University Bundang Hospital
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

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
2018 Year 07 Month 06 Day

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2018 Year 07 Month 02 Day
Anticipated trial start date
2018 Year 07 Month 02 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2018 Year 06 Month 28 Day
Last modified on
2018 Year 07 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037836

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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