UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053977 |
|---|---|
| Receipt number | R000061614 |
| Scientific Title | Postoperative delirium prevention and analgesic effects of continuous postoperative administration of dexmedetomidine for craniotomy |
| Date of disclosure of the study information | 2024/04/01 |
| Last modified on | 2024/03/26 22:13:19 |
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Basic information
Public title
Postoperative delirium prevention and analgesic effects of continuous postoperative administration of dexmedetomidine for craniotomy
Acronym
Delirium prevention and analgesic effect of dexmedetomidine
Scientific Title
Postoperative delirium prevention and analgesic effects of continuous postoperative administration of dexmedetomidine for craniotomy
Scientific Title:Acronym
Delirium prevention and analgesic effect of dexmedetomidine
Region
| Japan |
Condition
Condition
Neurosurgery craniotomy
Classification by specialty
| Anesthesiology | Neurosurgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
It has been suggested that intraoperative dexmedetomidine administration may be effective for postoperative analgesia. In neurosurgery, the use of postoperative opioids is not necessarily appropriate because it causes side effects such as nausea and delirium. One candidate analgesic to replace opioids is dexmedetomidine, and the purpose of this study is to demonstrate the analgesic effect of its postoperative administration.
Additionally, if dexmedetomidine's sedative effect can prevent delirium and exert analgesic effect, it is considered to be a useful analgesic alternative to opioids.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Analgesic effect of dexmedetomidine
Key secondary outcomes
Delirium prevention
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Dexmedetomidine administration group
Interventions/Control_2
Physiological saline administration group
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients undergoing craniotomy
Key exclusion criteria
emergency surgery patient
Patients with ASA-PS3 or higher
Patients with contraindications to haloperidol, such as Parkinson's disease
Patients with renal impairment and contraindication to NSAIDs
Patients who are allergic to other drugs used
Patients who cannot consent
minor
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Akiyuki |
| Middle name | |
| Last name | Sakamoto |
Organization
Shinonoi general hospital
Division name
Anesthesiology
Zip code
3888004
Address
666-1 Ai, Shinonoi, Nagano city, Nagano prefecture
TEL
0262922261
akiyuki@shinonoi-hp.jp
Public contact
Name of contact person
| 1st name | Akiyuki |
| Middle name | |
| Last name | Sakamoto |
Organization
shinonoi general hospital
Division name
Anesthesiology
Zip code
3888004
Address
666-1 Ai, Shinonoi, Nagano city, Nagano prefecture
TEL
0262922261
Homepage URL
akiyuki@shinonoi-hp.jp
Sponsor or person
Institute
Shinonoi general hospital
Institute
Department
Personal name
Funding Source
Organization
Nothing
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
Shinonoi general hospital
Address
666-1 Ai, Shinonoi, Nagano city, Nagano prefecture
Tel
0262922261
akiyuki@shinonoi-hp.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
| 2024 | Year | 04 | Month | 01 | 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 | 01 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 04 | Month | 01 | 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
| 2024 | Year | 03 | Month | 26 | Day |
Last modified on
| 2024 | Year | 03 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061614
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
