UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033178 |
|---|---|
| Receipt number | R000037836 |
| Scientific Title | 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 | 2020/12/08 10:30:35 |
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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
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
notinvasive@gmail.com
Sponsor or person
Institute
Seoul National University Bundang Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037836
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