UMIN-CTR Clinical Trial

Unique ID issued by UMIN	UMIN000048816
Receipt number	R000055632
Scientific Title	Prediction of postoperative effectiveness of nerve block in video/ robotic -assisted thoracoscopic surgery by using high frequency variability index (HFVI), an index of parasympathetic tone: prospective observational study
Date of disclosure of the study information	2022/09/01
Last modified on	2024/09/01 23:15:44

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Basic information

Public title

Prediction of postoperative effectiveness of nerve block in video/ robotic -assisted thoracoscopic surgery by using high frequency variability index (HFVI), an index of parasympathetic tone: prospective observational study

Acronym

Scientific Title

Scientific Title:Acronym

Region

Japan

Condition

Patients who recieve video-assisted thoracoscopic surgery [VATS] or robotic-assisted thoracic surgery [RATS]

Classification by specialty

Anesthesiology Intensive care medicine

Classification by malignancy

Malignancy

Genomic information

Objectives

Narrative objectives1

The aim of this study is to investigate the relationship between HFVI and the degree of postoperative pain by monitoring HFVI.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Assessment

Primary outcomes

The relationship between HFVI values at the end of surgery (just before awakening from general anesthesia) and maximum NRS (greater than/less than 3) from the end of surgery to the day after surgery.

Key secondary outcomes

The relationship between HFVI value immediately before extubation (before awakening from general anesthesia) after completion of surgery and morphine usage from the end of surgery to the next day of surgery.

The relationship between the change in HFVI before and after regional anesthesia (initial local anesthesia via epidural catheter or nerve block after induction of general anesthesia) and the maximum NRS (greater than or less than 3) from the end of surgery to the next day after surgery.

The relationshiip between HFVI values at the end of surgery and the incidence of delirium diagnosed by CAM-ICU (diagnostic tool for delirium in the ICU).

The relationship between HFVI values immediately before extubation after surgery (before awakening from general anesthesia) and the incidence of PONV up to the day after surgery.

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

18 years-old <=

Age-upper limit

120 years-old >=

Gender

Male and Female

Key inclusion criteria

The 48 adult patients who are scheduled to receive general anesthesia under intubation at our hospital and who meet all of the following criteria:

1) Patients undergoing video/robotic -assisted thoracic surgery under general anesthesia with continuous nerve block at our hospital and scheduled to be admitted to our ICU after surgery.

2) Patient has ASA (American Society of Anesthesiologists) classification 1-3.

3) Written consent has been obtained

Key exclusion criteria

Exclude patients and timings with any of the following:
1) Under the age of 18 years old

2) Patients who are expected to be unable to respond to NRS due to severe dementia or sequelae of cerebral infarction

3) Patients with severe arrhythmia

4) Patients using beta-blockers before and during surgery

5) Immediately after using atropine

6) Use of sedatives such as dexmedetomidine after ICU admission

7) Respiratory rate less than 9 times/min

8) severe asthma

9)Skin disease on the anterior chest (where the sensor is attached)

Target sample size

Research contact person

Name of lead principal investigator

1st name Keisuke

Middle name

Last name Yoshida

Organization

Fukushima Medical University

Division name

Department of Anesthesiology

Zip code

9601295

Address

1 Hikarigaoka, Fukushima, Fukushima

TEL

0245471342

Email

kei-y7of@fmu.ac.jp

Public contact

Name of contact person

1st name Keisuke

Middle name

Last name Yoshida

Organization

Fukushima Medical University

Division name

Department of Anesthesiology

Zip code

9601295

Address

1 Hikarigaoka, Fukushima, Fukushima

TEL

0245471342

Homepage URL

Email

kei-y7of@fmu.ac.jp

Sponsor or person

Institute

Fukushima Medical University

Institute

Department

Personal name

Funding Source

Organization

Fukushima Medical University

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

Ethics Committee of Fukushima

Address

1 Hikarigaoka, Fukushima, Fukushima

Tel

0245471825

Email

rs@fmu.ac.jp

Secondary IDs

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Other administrative information

Date of disclosure of the study information

2022 Year 09 Month 01 Day

Related information

URL releasing protocol

Publication of results

Partially published

Result

URL related to results and publications

https://doi.org/10.1007/s10877-024-01205-7

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

Completed

Date of protocol fixation

2022 Year 09 Month 01 Day

Date of IRB

2023 Year 03 Month 20 Day

Anticipated trial start date

2023 Year 03 Month 20 Day

Last follow-up date

2026 Year 03 Month 31 Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other

Other related information

We collect the following data
# Patient information: age, sex, height, weight, body surface area, underlyinghealth condition, preoperative disease, surgical procedure
# HFVI: during surgery, especially HFVI just before extubation, HFVI before and after regional anesthesia. Intraoperative HFVI was blinded to the anesthesia provider.
# NRS: NRS at rest every 2 hours after admission to the ICU from the end of surgery to the next day (set to 0 during sleep)
# Anesthesia method, drugs used during anesthesia (opioids, postoperative analgesics, local anesthetics used for regional anesthesia), effect site concentrations of fentanyl and remifentanil at the end of surgery , as a single index)
# The type and amount of analgesics used after surgery, and the amount of morphine used
# Presence or absence of postoperative delirium, postoperative nausea and vomiting (PONV), and other complications

Management of general anesthesia follows the normal management policy of our hospital. In addition, post-ICU analgesia management will be performed according to the following policy:

1. Administer 1000 mg of acetaminophen every 6 hours unless contraindicated (the dose will be reduced according to body weight).
2. Continue continuous regional anesthesia (epidural anesthesia or nerve block) if in place.
3. If NRS is 3 or more, or if the patient desires additional analgesia, administer morphine 0.5-1 mg intravenously using iv-PCA.

Management information

Registered date

2022 Year 09 Month 01 Day

Last modified on

2024 Year 09 Month 01 Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055632