UMIN-CTR Clinical Trial

Basic information
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
Condition	Lung cancer patients
Classification by specialty	Chest surgery Anesthesiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
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

Assessment
Primary outcomes	Partial pressure of arterial blood oxygen during one-lung ventilation
Key secondary outcomes	Evaluation of awakening Immunosuppressive effect

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	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

Research contact person
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

Public contact
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

Sponsor
Institute	Department of anesthesiology and pain medicine, Juntendo University
Institute
Department

Funding Source
Organization	Japan Science and Technology Agency
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Juntendo University
Address	2-1-1, Hongo. Bunkyo-ku, Tokyo
Tel	0338133111
Email	kenkyu5858@juntendo.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	2021 Year 04 Month 25 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	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

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.

Management information
Registered date	2021 Year 04 Month 21 Day
Last modified on	2021 Year 12 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049602