UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043879 |
|---|---|
| Receipt number | R000050079 |
| Scientific Title | Inhibition of Metabolism by a General Anesthetic (Remimazolam) Using Indirect Calorimetry -A Prospective Observational Study- |
| Date of disclosure of the study information | 2021/04/10 |
| Last modified on | 2025/10/12 07:11:34 |
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Basic information
Public title
Inhibitory effect of general anesthetics (remimazolam) on metabolism
Acronym
Inhibitory effect of general anesthetics (remimazolam) on metabolism
Scientific Title
Inhibition of Metabolism by a General Anesthetic (Remimazolam) Using Indirect Calorimetry
-A Prospective Observational Study-
Scientific Title:Acronym
Inhibition of Metabolism by a General Anesthetic (Remimazolam) Using Indirect Calorimetry
-A Prospective Observational Study-
Region
| Japan |
Condition
Condition
Surgical cases undergoing general anesthesia
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the inhibitory effect of remimazolam on metabolism before and after induction of general anesthesia.
Basic objectives2
Pharmacodynamics
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase II
Assessment
Primary outcomes
Compare oxygen consumption, carbon dioxide production, and total energy expenditure before and after induction of general anesthesia.
Key secondary outcomes
Compare biological signs (blood pressure, heart rate, cardiac output, BIS) and oxygen supply/demand balance indices (CaO2, DO2, ERO2) before and after induction of general anesthesia.
Comparison of drug effect site concentrations (remimazolam, remifentanil, fentanyl, volume of supplemental fluid, hypertensive drugs, etc.) after induction of general anesthesia.
Compare the respiratory status of spontaneous breathing (volume and frequency of breathing) and ventilator settings during general anesthesia (volume and frequency of breathing, maximum airway pressure, compliance, and dead space volume).
Factors contributing to the difference in EE before and after induction will be investigated by multivariate analysis.
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients undergoing general anesthesia with remimazolam under endotracheal intubation control in our operating room who have given consent to participate in the study.
Key exclusion criteria
Patient factors: allergy to any of the components of remimazolam, history of central nervous system disease (cerebral infarction, cerebral hemorrhage, etc.), neuromuscular disease (myasthenia gravis, etc.), uncontrolled heart failure or respiratory failure, renal failure (serum creatinine > 2 mg/dl), liver failure (AST/ ALT > 2.5 ULN), and patients who do not consent to the study. ALT>2.5ULN), and those who do not consent to the study.
Surgical factors: surgery requiring repositioning or isolated lung ventilation, head and neck surgery, emergency surgery
Target sample size
14
Research contact person
Name of lead principal investigator
| 1st name | Kaneyuki |
| Middle name | |
| Last name | Kawamae |
Organization
Yamagata University Medical School Hospital
Division name
Department of Anesthesiology
Zip code
9909585
Address
2-2-2, Iida-Nishi, Yamagata City, Yamagata Prefecture
TEL
0236285400
yarimizu.kenya@gmail.com
Public contact
Name of contact person
| 1st name | Kenya |
| Middle name | |
| Last name | Yarimizu |
Organization
Yamagata University Medical School Hospital
Division name
Department of Anesthesiology
Zip code
9909585
Address
2-2-2, Iida-Nishi, Yamagata City, Yamagata Prefecture
TEL
0236285400
Homepage URL
yarimizu.kenya@gmail.com
Sponsor or person
Institute
Department of Anesthesiology, Department of Anesthesiology
Institute
Department
Personal name
Funding Source
Organization
Department of Anesthesiology, Department of Anesthesiology
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
Yamagata University Medical School Hospital
Address
2-2-2, Iida-Nishi, Yamagata City, Yamagata Prefecture
Tel
0236285400
yarimizu.kenya@gmail.com
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 | 10 | Day |
Related information
URL releasing protocol
https://pubmed.ncbi.nlm.nih.gov/38842681/
Publication of results
Partially published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/38842681/
Number of participants that the trial has enrolled
13
Results
Results: VO2, VCO2, and DO2 decreased significantly from T1 to T2 and T3 [VO2/body surface area (BSA) (ml/min/m2): T1, 130 (122-146); T2, 107 (83-139); T3, 97 (93-121); p = 0.011], [VCO2/BSA (ml/min/m2): T1, 115 (105-129); T2, 90 (71-107); T3, 81 (69-101); p = 0.011], [DO2/BSA (ml/min/m2): T1, 467 (395-582); T2, 347 (286-392); T3, 382 (238-414); p = 0.0020].
Results date posted
| 2025 | Year | 10 | Month | 12 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
This study included patients scheduled for surgery in whom remimazolam was administered as a general anesthetic.
Participant flow
VO2 and VCO2 were measured at different intervals: upon awakening (T1), 15 min after tracheal intubation (T2), and 1 h after T2 (T3). Oxygen delivery (DO2) was calculated simultaneously with these measurements. VO2 was ascertained using an indirect calorimeter and further calculated using vital signs, among other factors. DO2 was derived from cardiac output and arterial blood gas analysis performed with an arterial pressure-based cardiac output measurement system.
Adverse events
none
Outcome measures
VO2 and VCO2, DO2
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 04 | Month | 07 | Day |
Date of IRB
| 2021 | Year | 04 | Month | 07 | Day |
Anticipated trial start date
| 2021 | Year | 04 | Month | 12 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
1-1. After entering the operating room, transcutaneous oxygen saturation measurement, electrocardiogram measurement, non-invasive arterial pressure measurement, peripheral venous line securement, arterial line securement, and body temperature measurement are performed.
Arterial blood gas measurement is performed about once an hour from the time of entering the operating room to the time of leaving the room. All other monitoring should be performed continuously from the time the patient enters the operating room to the time the patient leaves.
2. Before induction of general anesthesia (T1), record the basic metabolic rate using an indirect calorimeter (Measurement 1). (Metabolic rate measurement should be performed for at least 5 minutes after the start of measurement, and for about 5 minutes after hemodynamic stability. Measurements (1) and (2) should be averaged over 5 minutes.)
Perform preoxygenation for about 2-3 minutes.
4-1. Administer remimazolam 12 mg/kg/hr and remifentanil 0.2-0.5 mcg/kg/min. When sleep is confirmed, reduce the dose to remimazolam 1.0 mg/kg/hr and give rocuronium 0.8 mg/kg. Two to three minutes later, intubation is performed. After intubation, the dose of remifentanil should be reduced to 0.1 mcg/kg/min to maintain anesthesia.
After tracheal intubation and stabilization of hemodynamic and respiratory status (T2), metabolic rate is measured using an indirect calorimeter (Measurement 2).
6. From T2 to the end of surgery (Tn (n>=3)), metabolic rate measurement is performed once an hour (Measurement n (n>=3)).
Management information
Registered date
| 2021 | Year | 04 | Month | 09 | Day |
Last modified on
| 2025 | Year | 10 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050079
