UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051558 |
|---|---|
| Receipt number | R000058824 |
| Scientific Title | Optimal analgesia with remifentanil for patients requiring postoperative intensive care. |
| Date of disclosure of the study information | 2023/07/20 |
| Last modified on | 2024/12/01 01:11:55 |
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Basic information
Public title
Optimal analgesia with remifentanil for patients requiring postoperative intensive care.
Acronym
I-pooR
Scientific Title
Optimal analgesia with remifentanil for patients requiring postoperative intensive care.
Scientific Title:Acronym
I-pooR
Region
| Japan |
Condition
Condition
Admission to the Surgical Intensive Care Unit (SICU) after surgery under general anesthesia.
Classification by specialty
| Surgery in general | Anesthesiology | Intensive care medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Clarify the relationship between our group's newly proposed opioid sensitivity index (MECk: Minimum Evoked Current of K) and the minimum amount of remifentanil required for postoperative analgesia.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Correlation between MECK and remifentanil dosage
Key secondary outcomes
Time required for remifentanil dosing rate to stabilize.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients who are at least 20 years of age at the time consent is obtained and who will be admitted to the SICU after surgery under general anesthesia.
2. Cases of observation arterial pressure measurement by radial artery.
3. Cases with consent for this study.
Key exclusion criteria
A) Cases with atrial fibrillation.
B) Cases in which it is inappropriate to perform the observation arterial manometry in the radial artery.
C) Patients with significant hemodynamic or neurologic impairment in the upper extremities.
D) Patients with severe stenosis or occlusive lesions in cerebral vessels.
E) Cases with contraindications to remifentanil, propofol, or rocuronium.
F) Patients who are regularly using opioids.
G) Cases in which prior consent has been withdrawn.
H) Cases in which the anesthesiologist deems the patient unfit to perform this study.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Yasuo |
| Middle name | M |
| Last name | Tsutsumi |
Organization
Graduate School of Biomedical Sciences, Hiroshima University
Division name
Department of Anesthesiology and Critical Care
Zip code
734-8551
Address
1-2-3 Kasumi, Minami-ku, Hiroshima, Japan
TEL
082-257-5555
yasuo223@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Satoshi |
| Middle name | |
| Last name | Kamiya |
Organization
Graduate School of Biomedical Sciences, Hiroshima University
Division name
Department of Anesthesiology and Critical Care
Zip code
734-8551
Address
1-2-3 Kasumi, Minami-ku, Hiroshima, Japan
TEL
082-257-5555
Homepage URL
satobo-kamiya@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima 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
Ethical Committee for Epidemiology of Hiroshima University
Address
1-2-3 Kasumi, Minami-ku, Hiroshima, Japan
Tel
082-257-5907
iryo-seisaku@office.hiroshima-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 | 07 | Month | 20 | 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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 07 | Month | 20 | Day |
Date of IRB
| 2023 | Year | 06 | Month | 26 | Day |
Anticipated trial start date
| 2023 | Year | 07 | Month | 25 | 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
After initiation of treatment in the SICU
In principle, only propofol is used for sedation.
Sedation Scale (RASS) -1 or -2 should be maintained.
Analgesics should be remifentanil only, starting at Ce: 2 ng/ml, decreasing dose if BPS (Behavioral Pain Scale) is 3 or 4, unchanged if BPS is 5, and increasing dose if BPS is 6 or higher.
RASS and BPS are evaluated every hour, and the dosage rate of propofol and remifentanil is verified and adjusted each time.
The relationship between the MECK obtained in this way and the opioid dosage from the postoperative period to the next morning will be analyzed.
Management information
Registered date
| 2023 | Year | 07 | Month | 09 | Day |
Last modified on
| 2024 | Year | 12 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058824
