Unique ID issued by UMIN | UMIN000041355 |
---|---|
Receipt number | R000047215 |
Scientific Title | Comparison of remimazolam + flumazenil antagonization and propofol on emergence in awake craniotomy: a randomized comparative study |
Date of disclosure of the study information | 2020/08/11 |
Last modified on | 2021/08/10 15:00:07 |
Comparison of remimazolam + flumazenil antagonization and propofol on emergence time in patients who undergo awake craniotomy: a randomized comparative study
Efficacy of remimazolam + flumazenil antagonization and propofol in awake craniotomy
Comparison of remimazolam + flumazenil antagonization and propofol on emergence in awake craniotomy: a randomized comparative study
Efficacy of remimazolam + flumazenil antagonization and propofol in awake craniotomy
Japan |
brain tumor
Anesthesiology | Neurosurgery |
Malignancy
NO
Awake craniotomy is applied for temporal lobe brain tumor resection to improve postoperative physical function. Remimazolam, ultra-short acting benzodiazepin, is able to be antagonized by flumazenil, thus it can produce rapid emergence from anesthesia. The purpose of this study is to compare time needed for emergence from general anesthesia between remimazolam + flumazenil antagonization and propofol, conventional sedative.
Safety,Efficacy
Confirmatory
Explanatory
Not applicable
Time required for emergence from anesthesia
Time required for extubation
Time course of sedative score
Serum concentration of remimazolam and propofol
Blood pressure, heart rate and SpO2 during general anesthesia
Incidence of awake craniotomy failure
Dose of flumazenil
Incidence of unintended re-sedation during awake phase
Dose required for re-anesthesia induction
Time required for re-anesthesia induction
Time required for re-emergence
Incidence of nausea and vomiting during awake phase
Interventional
Parallel
Randomized
Individual
Single blind -participants are blinded
Active
NO
NO
Institution is not considered as adjustment factor.
NO
Numbered container method
2
Treatment
Medicine |
Remimazolam with flumazenil antagonization is administered in anesthetic management of awake craniotomy
Propofol is administered in anesthetic management fo awake craniotomy
65 | years-old | <= |
100 | years-old | > |
Male and Female
Patient aged more than 65 years old age
Patient who undergo elective awake craniotomy using asleep-awake-asleep technique
Patient whose preoperative physical status is good (ASA-PS 1-3)
Patient who has allergy for propofol, remimazolam and flumazenil
Patient who has severe hepatic and/or renal dynfunction
Patient who determined as inappropriate for enrollment by the researcher of this study
126
1st name | Shunsuke |
Middle name | |
Last name | Tachibana |
Sapporo Medical University School of Medicine
Department of Anesthesiology
0608543
291, South 1, West 16, Chuo-ku, Sapporo
011-611-2111
chakitomohiro0728@yahoo.co.jp
1st name | Tomohiro |
Middle name | |
Last name | Chaki |
Sapporo Medical University School of Medicine
Department of Anesthesiology
0608534
291, South 1, West 16, Chuo-ku, Sapporo
011-611-2111
chakitomohiro0728@yahoo.co.jp
Sapporo Medical University School of Medicine
Sapporo Medical University School of Medicine
Self funding
IRB of Sapporo Medical School of University Hospital
291, South 1, West 16, Chuo-ku, Sapporo
011-611-2111
chakitomohiro0728@yahoo.co.jp
NO
札幌医科大学附属病院(北海道)
2020 | Year | 08 | Month | 11 | Day |
Unpublished
Open public recruiting
2020 | Year | 07 | Month | 09 | Day |
2020 | Year | 08 | Month | 03 | Day |
2020 | Year | 08 | Month | 11 | Day |
2025 | Year | 03 | Month | 31 | Day |
2020 | Year | 08 | Month | 08 | Day |
2021 | Year | 08 | Month | 10 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047215
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |