Unique ID issued by UMIN | UMIN000043879 |
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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 | 2022/01/04 09:23:47 |
Inhibitory effect of general anesthetics (remimazolam) on metabolism
Inhibitory effect of general anesthetics (remimazolam) on metabolism
Inhibition of Metabolism by a General Anesthetic (Remimazolam) Using Indirect Calorimetry
-A Prospective Observational Study-
Inhibition of Metabolism by a General Anesthetic (Remimazolam) Using Indirect Calorimetry
-A Prospective Observational Study-
Japan |
Surgical cases undergoing general anesthesia
Anesthesiology |
Others
NO
To clarify the inhibitory effect of remimazolam on metabolism before and after induction of general anesthesia.
Pharmacodynamics
Confirmatory
Explanatory
Phase II
Compare oxygen consumption, carbon dioxide production, and total energy expenditure before and after induction of general anesthesia.
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.
Observational
18 | years-old | <= |
85 | years-old | >= |
Male and Female
Patients undergoing general anesthesia with remimazolam under endotracheal intubation control in our operating room who have given consent to participate in the study.
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
14
1st name | Kaneyuki |
Middle name | |
Last name | Kawamae |
Yamagata University Medical School Hospital
Department of Anesthesiology
9909585
2-2-2, Iida-Nishi, Yamagata City, Yamagata Prefecture
0236285400
yarimizu.kenya@gmail.com
1st name | Kenya |
Middle name | |
Last name | Yarimizu |
Yamagata University Medical School Hospital
Department of Anesthesiology
9909585
2-2-2, Iida-Nishi, Yamagata City, Yamagata Prefecture
0236285400
yarimizu.kenya@gmail.com
Department of Anesthesiology, Department of Anesthesiology
Department of Anesthesiology, Department of Anesthesiology
Self funding
Yamagata University Medical School Hospital
2-2-2, Iida-Nishi, Yamagata City, Yamagata Prefecture
0236285400
yarimizu.kenya@gmail.com
NO
2021 | Year | 04 | Month | 10 | Day |
Unpublished
No longer recruiting
2021 | Year | 04 | Month | 07 | Day |
2021 | Year | 04 | Month | 07 | Day |
2021 | Year | 04 | Month | 12 | Day |
2022 | Year | 03 | Month | 31 | Day |
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)).
2021 | Year | 04 | Month | 09 | Day |
2022 | Year | 01 | Month | 04 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050079
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