UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022599 |
|---|---|
| Receipt number | R000026048 |
| Scientific Title | Infusion Rate of Rocuronium for Deep Neuromuscular Blockade |
| Date of disclosure of the study information | 2016/06/03 |
| Last modified on | 2023/05/06 11:57:46 |
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Basic information
Public title
Infusion Rate of Rocuronium for Deep Neuromuscular Blockade
Acronym
Infusion Rate of Rocuronium for Deep Neuromuscular Blockade
Scientific Title
Infusion Rate of Rocuronium for Deep Neuromuscular Blockade
Scientific Title:Acronym
Infusion Rate of Rocuronium for Deep Neuromuscular Blockade
Region
| Japan |
Condition
Condition
Elective surgical patients
Classification by specialty
| Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Although previous studies showed that surgical conditions were improved with deep neuromuscular blockade (NMB), the infusion rate of rocuronium for deep NMB remains unclear. The purpose of this study is to evaluate the infusion rate of rocuronium to maintain deep NMB.
Basic objectives2
Pharmacodynamics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Infusion rate of rocuronium to maintain the neuromuscular blockade at 1 to 5 of post tetanic count at adductor pollicis.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
6
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Initial dose of rocuronium: 0.6 mg/kg, Maintenance of anesthesia: propofol.
Interventions/Control_2
Initial dose of rocuronium: 0.6 mg/kg, Maintenance of anesthesia: desflurane.
Interventions/Control_3
Initial dose of rocuronium: 0.6 mg/kg, Maintenance of anesthesia: sevoflurane.
Interventions/Control_4
Initial dose of rocuronium: 0.9 mg/kg, Maintenance of anesthesia: propofol.
Interventions/Control_5
Initial dose of rocuronium: 0.9 mg/kg, Maintenance of anesthesia: sevoflurane.
Interventions/Control_6
Initial dose of rocuronium: 0.9 mg/kg, Maintenance of anesthesia: desflurane.
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Acquisition of written informed consent.
2. Elective surgical patients.
3. Age; 20 years old or more and less than 65 years old.
4. Duration of anesthesia; 1.5 to 5 hours.
Key exclusion criteria
1. American Society of Anesthesiologists criteria; 3 or more.
2. Pregnant patients.
3. Body mass index; 30 kg/m2 or more.
4. Body mass index; less than 18.5 kg/m2.
5. Severe renal dysfunction patients; serum creatinine exceeded reference value.
6. Hepatic dysfunction patients; serum transaminase more than 100 U/L.
7. Patients with metabolic disorder.
8. Patients with neuromuscular disorder.
9. Patients with dyspnea, airway stenosis, and/or bronchial asthma.
10. Patients with hypersensitivity for rocuronium or sugammadex.
11. Patients with atopic disease.
12. Patients with systemic allergic symptoms.
13. Taking antihistamine and/or antiallergic drugs for more than a month.
14. Taking calcium antagonists, anticonvulsant agents, aminoglycoside antibiotics, polypeptide antibiotics, and/or metronidazole.
15. Patients required management with hypothermia during surgery.
16. Difficulty with appropriate neuromuscular monitoring.
17. Emergency surgical patients.
18. Patients with life-threatening medical condition.
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi Sunaga |
Organization
Jikei University School of Medicine
Division name
Department of Anesthesiology
Zip code
Address
3-25-8 Nishishimbashi, Minato-ku, Tokyo, Japan
TEL
03-3433-1111ext.4040
hs-031@jikei.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroshi Sunaga |
Organization
Jikei University School of Medicine
Division name
Department of Anesthesiology
Zip code
Address
3-25-8 Nishishimbashi, Minato-ku, Tokyo, Japan
TEL
03-3433-1111ext.4040
Homepage URL
hs-031@jikei.ac.jp
Sponsor or person
Institute
Jikei University School of Medicine,
Department of Anesthesiology
Institute
Department
Personal name
Funding Source
Organization
Jikei University School of Medicine,
Department of Anesthesiology
Organization
Division
Category of Funding Organization
Other
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
東京慈恵会医科大学附属病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 06 | Month | 03 | 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
Open public recruiting
Date of protocol fixation
| 2016 | Year | 04 | Month | 08 | Day |
Date of IRB
| 2016 | Year | 04 | Month | 08 | Day |
Anticipated trial start date
| 2016 | Year | 06 | Month | 03 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 06 | Month | 03 | Day |
Last modified on
| 2023 | Year | 05 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026048
