UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050673 |
|---|---|
| Receipt number | R000057736 |
| Scientific Title | Effect of intravenous lidocaine on the neuromuscular blockade by rocuronium. |
| Date of disclosure of the study information | 2023/06/26 |
| Last modified on | 2024/03/29 11:17:57 |
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Basic information
Public title
Effect of intravenous lidocaine on the neuromuscular blockade by rocuronium.
Acronym
Effect of intravenous lidocaine on the neuromuscular blockade by rocuronium.
Scientific Title
Effect of intravenous lidocaine on the neuromuscular blockade by rocuronium.
Scientific Title:Acronym
Effect of intravenous lidocaine on the neuromuscular blockade by rocuronium.
Region
| Japan |
Condition
Condition
Patients undergoing general anesthesia
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of lidocaine on the onset and duration of neuromuscular blockade by rocuronium.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Onset time (from the time of administration of rocuronium to maximum suppression of the twitch response)
Key secondary outcomes
1) 50% depression time (from the time of administration of rocuronium to 50% suppression of the twitch response)
2) 100% depression time (from the time of administration of rocuronium to 100% suppression of the twitch response)
3) T1 recovery time (from the time of administration of rocuronium to recovery of the twitch response)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Lidocaine (1.5 mg/kg) will be administered before rocuronium administration.
Interventions/Control_2
Placebo (same volume of saline) will be administered before rocuronium administration.
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
| 50 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Patients scheduled for general anesthesia.
2) Patients aged 50-79 years old.
3) Patients who agreed to a written informed consent.
Key exclusion criteria
1) Patients with preoperative ALT > 100 U/L.
2) Patients with preoperative Cr > 1.5 mg/dL.
3) Patients with a history of neuromuscular disease.
4) Patients with drug sensitivity and allergy.
5) Patients with contraindications to lidocaine.
6) Patients using propranolol, amiodarone.
7) Patients who are judged to be inappropriate.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Shinya |
| Middle name | |
| Last name | Taguchi |
Organization
Kobe university graduate school of medicine
Division name
Division of anesthesiology, Department of surgery related
Zip code
650-0017
Address
7-5-2 Kusunoki-cho, Chuo-ku, Kobe-shi
TEL
078-382-6172
staguchi@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Shinya |
| Middle name | |
| Last name | Taguchi |
Organization
Kobe university graduate school of medicine
Division name
Division of anesthesiology, Department of surgery related
Zip code
650-0017
Address
7-5-2 Kusunoki-cho, Chuo-ku, Kobe-shi
TEL
078-382-6172
Homepage URL
staguchi@med.kobe-u.ac.jp
Sponsor or person
Institute
Kobe university
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
IRB committee Kobe University hospital
Address
7-5-2 Kusunokityo Kobe city Hyogo
Tel
078-382-5400
kainyu@med.kobe-u.ac.jp
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
| 2023 | Year | 06 | Month | 26 | 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
| 2023 | Year | 03 | Month | 22 | Day |
Date of IRB
| 2023 | Year | 06 | Month | 29 | Day |
Anticipated trial start date
| 2023 | Year | 07 | Month | 18 | Day |
Last follow-up date
| 2025 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 03 | Month | 25 | Day |
Last modified on
| 2024 | Year | 03 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057736
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| Registered date | File name |
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