UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057634 |
|---|---|
| Receipt number | R000065850 |
| Scientific Title | Evaluation of the Effect of Donepezil on Rocuronium-induced Neuromuscular Blockade: A Single-Center Prospective Observational Study |
| Date of disclosure of the study information | 2025/04/17 |
| Last modified on | 2025/04/17 09:05:47 |
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Basic information
Public title
Evaluation of the Effect of Donepezil on Rocuronium-induced Neuromuscular Blockade: A Single-Center Prospective Observational Study
Acronym
Evaluation of the Effect of Donepezil on Rocuronium-induced Neuromuscular Blockade
Scientific Title
Evaluation of the Effect of Donepezil on Rocuronium-induced Neuromuscular Blockade: A Single-Center Prospective Observational Study
Scientific Title:Acronym
Evaluation of the Effect of Donepezil on Rocuronium-induced Neuromuscular Blockade
Region
| Japan |
Condition
Condition
General anesthesia with neuromuscular blockade
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The use of cholinesterase inhibitors may alter the sensitivity to neuromuscular blocking agents, and this study aimed to clarify this potential interaction.
Basic objectives2
Pharmacodynamics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Time from Rocuronium Administration to Onset of Complete Neuromuscular Blockade
Time Required for Recovery from Neuromuscular Blockade
Key secondary outcomes
The association between differences in patient populations and variations in general anesthesia management, including the types and dosages of anesthetic agents, concomitant medications, and vital signs.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients undergoing general anesthesia
Aged 75 years or older
Obtained informed consent
Key exclusion criteria
Patients taking cholinesterase inhibitors other than donepezil
History of allergy to general anesthetic agents
Severe obesity or cachexia
Presence of a pacemaker or implantable cardioverter-defibrillator (ICD)
Presence of prosthetic devices in the upper limbs
Inappropriate indication for the use of neuromuscular blocking agents
Inappropriate for intravenous anesthetic induction
Presence of organ dysfunction
Emergency surgery
Deemed ineligible by the investigators
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Yuji |
| Middle name | |
| Last name | Suzuki |
Organization
Hamamatsu University School of Medicine
Division name
Department of Anesthesiology and Intensive Care Medicine
Zip code
431-3192
Address
1-20-1, Handayama, Chuoh-ku, Hamamatsu, Japan
TEL
0534352738
suzukiy@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | Yuji |
| Middle name | |
| Last name | Suzuki |
Organization
Hamamatsu University School of Medicine
Division name
Department of Anesthesiology and Intensive Care Medicine
Zip code
4313192
Address
1-20-1, Handayama, Chuoh-ku, Hamamatsu, Japan
TEL
0534352738
Homepage URL
suzukiy@hama-med.ac.jp
Sponsor or person
Institute
Hamamatsu University School of Medicine
Institute
Department
Personal name
Suzuki
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
Ethics Committee for Life Science and Medical Research, Hamamatsu University School of Medicine
Address
1-20-1, Handayama, Chuoh-ku, Hamamatsu, Japan
Tel
0534352680
rinri@hama-med.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
| 2025 | Year | 04 | Month | 17 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 10 | Month | 02 | Day |
Date of IRB
| 2024 | Year | 11 | Month | 07 | Day |
Anticipated trial start date
| 2025 | Year | 04 | Month | 17 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Single center, prospective, observation study
Management information
Registered date
| 2025 | Year | 04 | Month | 17 | Day |
Last modified on
| 2025 | Year | 04 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065850
