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 2024/03/22 10:03:36

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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

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

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

Scientific Title:Acronym

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

Region

Japan


Condition

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

NO


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

48


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

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

2022 Year 09 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


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

No longer recruiting

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 03 Month 22 Day



Link to view the page

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name