UMIN-ICDS Clinical Trial

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

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

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

Primary outcomes

The total dose of remifentanil administered between admission to the intensive care unit and the next morning

Key secondary outcomes

The mean score of HFVI, Total dose of sedative agents, The frequency of analgesics required after the termination of mechanical ventilatory support, VAS sore after the termination of mechanical ventilatory support, The development of delirium after the termination of mechanical ventilatory support, The cut-off value of HFVI score for BPS >5

Study type

Interventional

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

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

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, underwent previous cardiac surgery, have severe arrhythmia, atrial fibrillation, and an implanted pacemaker, require high doses of catecholamines, or take some opioid medications preoperatively.

Target sample size

60

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

Email

takasaki.yasushi.gl@ehime-u.ac.jp

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

Email

yukihiro.nakata.zd@ehime-u.ac.jp

Institute

Ehime university

Institute

Department

Personal name

Organization

Ehime university

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Ehime University Hospital, Clinical Research Support Centre

Address

454 Shitsukawa, Toon, Ehime, Japan

Tel

0899605914

Email

c-trials@m.ehime-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

08

Month

01

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

18

Day

Date of IRB

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 related information

Registered date

2023

Year

07

Month

24

Day

Last modified on

2023

Year

07

Month

24

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058919