UMIN-ICDS Clinical Trial

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

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

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

Primary outcomes

Correlation between MECK and remifentanil dosage

Key secondary outcomes

Time required for remifentanil dosing rate to stabilize.

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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G) Cases in which prior consent has been withdrawn.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

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

Email

yasuo223@hiroshima-u.ac.jp

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

Email

satobo-kamiya@hiroshima-u.ac.jp

Institute

Hiroshima University

Institute

Department

Personal name

Organization

Self funding

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Ethical Committee for Epidemiology of Hiroshima University

Address

1-2-3 Kasumi, Minami-ku, Hiroshima, Japan

Tel

082-257-5907

Email

iryo-seisaku@office.hiroshima-u.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2023

Year

07

Month

20

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Preinitiation

Date of protocol fixation

2023

Year

07

Month

20

Day

Date of IRB

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 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.

Registered date

2023

Year

07

Month

09

Day

Last modified on

2023

Year

07

Month

09

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058824