UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045849 |
|---|---|
| Receipt number | R000052342 |
| Scientific Title | Study on the efficacy and safety of Remimazolam in one lung ventilation. |
| Date of disclosure of the study information | 2021/11/01 |
| Last modified on | 2024/04/15 22:33:35 |
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Basic information
Public title
Study on the efficacy and safety of Remimazolam in one lung ventilation.
Acronym
Study on the efficacy and safety of Remimazolam in one lung ventilation.
Scientific Title
Study on the efficacy and safety of Remimazolam in one lung ventilation.
Scientific Title:Acronym
SEREV study
Region
| Japan |
Condition
Condition
Lung Neoplasms
Classification by specialty
| Chest surgery | Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
(1) Changes in respiratory status (mainly SpO2) will be recorded and evaluated when propofol or remimazolam is used for anesthesia during surgery, and a prospective randomized controlled trial will be conducted to see how the new drug remimazolam affects respiratory management during one-lung ventilation compared with conventional anesthetics.
(2) Changes in circulation during anesthesia will be evaluated as a secondary endpoint by recording changes in heart rate and blood pressure and the use of circulatory agonists such as hypertensive agents.
(3) The frequency of common complications associated with anesthesia will be evaluated as a secondary endpoint by the nursing staff in the ward by recording nausea and vomiting, delirium, memory before and after surgery, and intraoperative memory within 24 hours after returning from the operating room.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
To analyze the frequency and severity of hypoxemia in the remimazolam and propofol groups. During anesthesia, arterial partial pressure of oxygen, inhaled oxygen concentration, and P/F ratio (arterial partial pressure of oxygen/Inhaled oxygen concentration) immediately before one-lung ventilation, 30 minutes after the start of one-lung ventilation, and 1 hour after the start of six-lung ventilation.
Key secondary outcomes
Circulatory changes during anesthesia will be analyzed with respect to heart rate and blood pressure and the amount of boosting agents and other circulatory agonists used.
Usage of boosting agents (e.g., neocinesinezine, ephedrine, atropine, and calcicol) during anesthesia
Analysis of the presence and frequency of common intraoperative and postoperative complications associated with anesthesia.
Intraoperative vital sign abnormalities and other adverse events
During anesthesia, continuous monitoring of electrocardiogram, heart rate, percutaneous arterial blood oxygen saturation, and intra-arterial blood pressure will be performed using a monitoring device installed in each operating room to monitor for adverse events such as arrhythmia, deviations in heart rate and blood pressure, and respiratory depression. After administration, the patient should be evaluated for adverse events such as allergic symptoms (erythema, bronchospasm, anaphylaxis), delayed awakening, and convulsions in addition to the above.
Analysis of the presence and frequency of other intraoperative and postoperative complications associated with anesthesia
Presence of hypertension, hypotension, tachycardia, bradycardia, nausea, vomiting, delirium, intraoperative memory, pre- and post-anesthesia memory at the time of awakening and leaving the room - 24 hours after surgery
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
The standard drug group will be anesthetized with propofol administered by continuous intravenous infusion to maintain normal anesthesia. Basically, follow the package insert of the drug used. Anesthesia should be administered according to a predetermined protocol based on the dosage and administration according to the package insert.
Interventions/Control_2
The study group will receive continuous intravenous infusion of remimazolam as an anesthetic agent to maintain normal anesthesia. The basic procedure will be in accordance with the package insert of the drug used. Anesthesia will be administered according to a predetermined protocol based on the dosage and administration according to the package insert.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients aged 20 years and older undergoing lung surgery with one-lung ventilation and general anesthesia with epidural
Key exclusion criteria
If the research subject refuses to cooperate in the research.
Contraindications to the use of anesthetics.
If the subject has a disease that affects HPV.
In the case of a procedure in which one lung ventilation is frequently released intraoperatively, such as surgery for pneumothorax.
Patients with longitudinal tumors in the supine position who may require only short periods of one-lung ventilation.
If the patient is scheduled to receive intraoperative cardiopulmonary ventilation.
Patients with severe chronic lung disease (1 sec rate 50%or less, % lung capacity less than 80%)
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Hirotsugu |
| Middle name | |
| Last name | Okamoto |
Organization
Kitasato University
Division name
School of Medicine, Department of Anesthesiology
Zip code
252-0374
Address
1-15-1 Kitasato Minami-ku, Sagamihara-shi, Kanagawa-ken
TEL
0427788111
masui@med.kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | Takahiro |
| Middle name | |
| Last name | Honda |
Organization
Kitasato University
Division name
School of Medicine, Department of Anesthesiology
Zip code
252-0374
Address
1-15-1 Kitasato Minami-ku, Sagamihara-shi, Kanagawa-ken
TEL
0427788111
Homepage URL
serevstudy.contact@gmail.com
Sponsor or person
Institute
Kitasato University, School of Medicine, Department of Anesthesiology
Institute
Department
Personal name
Funding Source
Organization
Self-funding
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 Kitasato University School of Medicine and Hospital
Address
1-15-1 Kitasato Minami-ku, Sagamihara-shi, Kanagawa-ken
Tel
0427788273
rinri-n@kitasato-u.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
北里大学病院（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 11 | Month | 01 | Day |
Related information
URL releasing protocol
https://euroanaesthesia.org/2023/abstracts/
Publication of results
Partially published
Result
URL related to results and publications
https://euroanaesthesia.org/2023/abstracts/
Number of participants that the trial has enrolled
70
Results
An abstract of this study was presented at Euroanaesthesia 2023 (Glasgow, 2023). It has not yet been published as a paper and details will be published at the time of the paper's publication. There were no significant differences in oxygenation capacity at each time point. However, ephedrine use was significantly lower in the remimazolam group than in the propofol group.
Results date posted
| 2024 | Year | 04 | Month | 15 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2023 | Year | 06 | Month | 03 | Day |
Baseline Characteristics
No significant differences in patient background, respiratory function, surgical information, or adverse events were observed between the two groups.
Participant flow
As scheduled, 35 patients in each group were randomly assigned to complete anesthesia and subsequently discharged. No cases were lost to follow-up regarding intraoperative information or complications. Only one patient in the propofol group did not respond to the postoperative questionnaire.
Adverse events
Details will be announced at the time of publication of the paper. No serious adverse events occurred, and there were no significant differences in event rates between the two groups with or without general adverse events related to anesthetics.
Outcome measures
Details will be announced at the time of publication of the paper.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2021 | Year | 10 | Month | 13 | Day |
Date of IRB
| 2021 | Year | 10 | Month | 13 | Day |
Anticipated trial start date
| 2021 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 08 | Month | 31 | Day |
Date trial data considered complete
| 2022 | Year | 08 | Month | 31 | Day |
Date analysis concluded
| 2023 | Year | 10 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2021 | Year | 10 | Month | 25 | Day |
Last modified on
| 2024 | Year | 04 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052342
