UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051696 |
|---|---|
| Receipt number | R000058919 |
| Scientific Title | A study of analgesic nociception index-guided requiring a dose of remifentanil under continuous sedation in the intensive care unit |
| Date of disclosure of the study information | 2023/08/01 |
| Last modified on | 2025/05/28 14:21:44 |
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Basic information
Public title
A study of analgesic nociception index-guided requiring a dose of remifentanil during mechanical ventilatory support under continuous sedation in the intensive care unit
Acronym
A study of analgesic nociception index-guided requiring a dose of remifentanil under continuous sedation in the intensive care unit
Scientific Title
A study of analgesic nociception index-guided requiring a dose of remifentanil under continuous sedation in the intensive care unit
Scientific Title:Acronym
A study of analgesic nociception index-guided requiring a dose of remifentanil during mechanical ventilatory support under continuous sedation in the intensive care unit
Region
| Japan |
Condition
Condition
Postoperative patients required mechanical ventilatory support under continuous sedation in the intensive care unit
Classification by specialty
| Gastrointestinal surgery | Oto-rhino-laryngology | Anesthesiology |
| Oral surgery | Plastic surgery | Intensive care medicine |
| Nursing | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We investigate whether the required dose of remifentanil can be reduced by using HFVI score in postoperative patients who underwent mechanical ventilatory support in the intensive care unit.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The total dose of remifentanil administered between admission to the intensive care unit and eight hours after admission
Key secondary outcomes
The mean score of HFVI, the Total dose of sedative agents, the frequency of analgesics required after the termination of mechanical ventilatory support, the VAS score after the termination of mechanical ventilatory support, and the development of delirium after the termination of mechanical ventilatory support
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Dose comparison
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
During the surgery, the required dose of fentanyl is determined by the individual responsible anesthesiologist. The dose of fentanyl may probably be adjusted within the range of effect-site concentration of fentanyl less than the concentration permitting postoperative removal of a tracheal tube. Then, the continuous intravenous infusion of fentanyl is started a 0.25 ug/kg/hr.
The target effect-site concentration of fentanyl is approximately 1 ng/ml.
The continuous infusion of remifentanil is started at 0.025 ug/kg/min before leaving the operating room, and then patients were transferred to the intensive care unit.
We take one hour for the equivalation period after admission to the intensive care unit.
Then a staff nurse evaluates BPS score and HFVI score every 30 minutes.
If HFVI m is less than 50, we add 0.0125 ug/kg/min of remifentanil to the present dose.
If HFVI m is between 50 and 70 we reduce 0.0125 ug/kg/min of remifentanil from the present dose.
If BPS score is 5 or higher, we maintain the present dose.
If BPS score is more than 70, we reduce 0.0125 ug/kg/min of remifentanil from the present dose.
Interventions/Control_2
During the surgery, the required dose of fentanyl is determined by the individual responsible anesthesiologist. The dose of fentanyl may probably be adjusted within the range of effect-site concentration of fentanyl less than the concentration permitting postoperative removal of a tracheal tube. Then, the continuous intravenous infusion of fentanyl is started a 0.25 ug/kg/hr.
The target effect-site concentration of fentanyl is approximately 1 ng/ml.
The continuous infusion of remifentanil is started at 0.025 ug/kg/min before leaving the operating room, and then patients were transferred to the intensive care unit.
We take one hour for the equivalation period after admission to the intensive care unit.
Then a staff nurse evaluates BPS score and HFVI score every 30 minutes.
If the patient awakes and complains of pain, we add 0.0125 ug/kg/min of remifentanil to the present dose.
If the patient does not complain of pain, we reduce 0.0125 ug/kg/min of remifentanil from the present dose.
If BPS score is 5 or higher, we add 0.0125 ug/kg/min of remifentanil to the present dose.
If BPS score is 3 or lower, we reduce 0.0125 ug/kg/min of remifentanil from the present dose.
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
| 18 | years-old | <= |
Age-upper limit
| 99 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Postoperative patients required mechanical ventilatory support under a continuous infusion of sedative agents in intensive care until the next morning. The elective surgeries enrolled in this study are as followed, tumor resection and reconstruction by surgeons of otolaryngology or dental surgery or plastic surgery, upper and lower jaw migration by dental surgeons, and thoracoscopic esophageal malignancy surgery.
Key exclusion criteria
Patients are 18 years old or less, have severe arrhythmia, atrial fibrillation, and an implanted pacemaker, require high doses of catecholamines, or take some opioid medications preoperatively.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Yasushi |
| Middle name | |
| Last name | Takasaki |
Organization
Ehime University Hospital
Division name
Division of Intensive care unit
Zip code
791-0204
Address
454 Shitsukawa, Toon, Ehime, Japan
TEL
0899605383
takasaki.yasushi.gl@ehime-u.ac.jp
Public contact
Name of contact person
| 1st name | Yukihiro |
| Middle name | |
| Last name | Nakasaki |
Organization
Ehime University Hospital
Division name
Division of Intensive care unit
Zip code
791-0204
Address
454 Shitsukawa, Toon, Ehime, Japan
TEL
0899605383
Homepage URL
yukihiro.nakata.zd@ehime-u.ac.jp
Sponsor or person
Institute
Ehime university
Institute
Department
Personal name
Funding Source
Organization
Ehime university
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
Ehime University Hospital, Clinical Research Support Centre
Address
454 Shitsukawa, Toon, Ehime, Japan
Tel
0899605914
c-trials@m.ehime-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 | 08 | 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
62
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 | 07 | Month | 18 | Day |
Date of IRB
| 2023 | Year | 07 | Month | 26 | Day |
Anticipated trial start date
| 2023 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2028 | 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
| 2023 | Year | 07 | Month | 24 | Day |
Last modified on
| 2025 | Year | 05 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058919
