UMIN-CTR Clinical Trial

Public title

Comparison of intraoperative intravenous anesthetic agents (propofol and remimazolam) in patients with lung cancer :prospective cohort study

Acronym

Comparison of intravenous anesthetic agents in patients with lung cancer

Scientific Title

Comparison of intraoperative intravenous anesthetic agents (propofol and remimazolam) in patients with lung cancer: prospective cohort study

Scientific Title:Acronym

Comparison of intravenous anesthetic agents in patients with lung cancer: prospective cohort study

Region

Japan

Condition

Lung cancer patients

Classification by specialty

Chest surgery

Anesthesiology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

High quality anesthesia leads to safe surgery and improved patient prognosis and surgical outcomes. Currently, propofol is the most widely used intravenous anesthetic for general anesthesia, but in 2020, remimazolam, an ultra-short-acting benzodiazepine, was launched in Japan ahead of other countries.
In respiratory surgery, one-lung ventilation is used. In other departments where one-lung ventilation is not used, induction of anesthesia is performed with propofol, and maintenance of anesthesia is often performed with inhalation of anesthetics, but these inhalation of anesthetics are thought to be disadvantageous in oxygenation during one-lung ventilation. Therefore, intravenous anesthetics are thought to be more advantageous for oxygenation during one-lung ventilation, and intravenous anesthetics are mainly used in lung cancer surgery not only for induction, but also for maintenance of anesthesia. Although the new drug remimazolam anesthesia is considered to have the advantages, a detailed study of its advantages and disadvantages compared to propofol anesthesia in actual clinical practice has not yet been conducted. Therefore, we will conduct an observational study to compare two intravenous anesthetics in respiratory surgery, where intravenous anesthetics are mainly used.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Partial pressure of arterial blood oxygen during one-lung ventilation

Key secondary outcomes

Evaluation of awakening
Immunosuppressive effect

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

80

years-old

>=

Gender

Male and Female

Key inclusion criteria

Operate on one side of the lung.
Patients diagnosed with primary and metastatic lung cancer.
Hospitalized patients.
Those who, after receiving sufficient explanation and understanding, have given written consent of their own free will to participate in this research.

Key exclusion criteria

Patients whose consent was not obtained.
Patients who are taking immunosuppressive drugs or steroids.
Patients who have already received chemoradiation therapy.
Simultaneous bilateral surgery.
Patients with autoimmune diseases such as collagen diseases.
Cardiac disease of NYHA III degree or higher.
Respiratory dysfunction with a VC or FEV1 of less than 50%.
Pulmonary hypertension with mean pulmonary artery pressure of 30 mmHg or more.
Highly obese patients with BMI greater than 30.
Severe hepatic or renal dysfunction.
Patients with allergy to propofol or benzodiazepine anesthetics.
Other patients who are judged by the principal investigator to be inappropriate as research subjects.

Target sample size

150

Name of lead principal investigator

1st name	Izumi
Middle name
Last name	Kawagoe

Organization

Juntendo University

Division name

Department of anesthesiology and pain medicine

Zip code

113-8421

Address

2-1-1, Hongo, Bunkyo-ku, Tokyo

TEL

0338133111

Email

ikawago@juntendo.ac.jp

Name of contact person

1st name	Tsukasa
Middle name
Last name	Kochiyama

Organization

Juntendo University

Division name

Department of anesthesiology and pain medicine

Zip code

113-8421

Address

2-1-1, Hongo, Bunkyo-ku, Tokyo

TEL

0338133111

Homepage URL

Email

tkouchi@juntendo.ac.jp

Institute

Department of anesthesiology and pain medicine, Juntendo University

Institute

Department

Personal name

Organization

Japan Science and Technology Agency

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Juntendo University

Address

2-1-1, Hongo. Bunkyo-ku, Tokyo

Tel

0338133111

Email

kenkyu5858@juntendo.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

2021

Year

04

Month

25

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

Open public recruiting

Date of protocol fixation

2021

Year

04

Month

12

Day

Date of IRB

2021

Year

04

Month

12

Day

Anticipated trial start date

2021

Year

05

Month

01

Day

Last follow-up date

2024

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

In this study, we will do anesthesia as usual in patients with lung cancer who have given informed consent. The anesthesiologist in charge of the patient will decide which intravenous anesthetic is considered appropriate for the patient. The data obtained before and after the surgery will be collected and analyzed.
Evaluate the quality of oxygenation and arousal during and after surgery. The incidence of vascular pain will be graded and evaluated by grade (Grade 1: patient spontaneously complains of pain, Grade 2: patient complains of pain upon confirmation of pain by the anesthesiologist, Grade 3: patient does not complain of pain but presents an agonized face, Grade 4: no pain).
Immunological evaluation. To assess immunosuppression, peripheral blood samples will be collected preoperatively, intraoperatively, and on days 1, 3, and 5 postoperatively, and the leukocyte fraction will be measured to calculate the number of neutrophils, monocytes, and lymphocytes in the peripheral blood and their percentage in the white blood cells. Plasma concentrations of inflammatory and anti-inflammatory cytokines will be measured by ELISA. Peripheral blood mononuclear cells isolated from peripheral blood will be analyzed by flow cytometer.

Registered date

2021

Year

04

Month

21

Day

Last modified on

2021

Year

12

Month

20

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049602