UMIN-CTR Clinical Trial

Basic information
Public title	Evaluation of surgical condition during Interventional Neuroradiology (INR) in patients with deep vs moderate neuromuscular block
Acronym	Evaluation of surgical condition during Interventional Neuroradiology (INR) in patients with deep vs moderate neuromuscular block
Scientific Title	Evaluation of surgical condition during Interventional Neuroradiology (INR) in patients with deep vs moderate neuromuscular block
Scientific Title:Acronym	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	1st name Middle name Last name Jin Hee Kim
Organization	Seoul National University Bundang Hospital
Division name	Department of Anesthesiology and Pain Medicine
Zip code
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	1st name Middle name Last name Bo Young Kim
Organization	Seoul National University Bundang Hospital
Division name	Department of Anesthesiology and Pain Medicine
Zip code
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)

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	2018 Year 07 Month 06 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	Completed
Date of protocol fixation	2018 Year 07 Month 02 Day
Date of IRB	2018 Year 06 Month 20 Day
Anticipated trial start date	2018 Year 07 Month 02 Day
Last follow-up date	2018 Year 12 Month 13 Day
Date of closure to data entry	2018 Year 12 Month 13 Day
Date trial data considered complete	2018 Year 12 Month 13 Day
Date analysis concluded	2019 Year 09 Month 11 Day

Other
Other related information

Management information
Registered date	2018 Year 06 Month 28 Day
Last modified on	2020 Year 12 Month 08 Day

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