Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study aims to find effective dose of remimazolam for inducing loss of consciousness in children aged 2 to 8 years old. We will explore ED90 of remimazolam for loss of consciousness in 2 minutes after intravenous injection, via a up-and-down method with biased-coin design.
We will administer remimazolam intravenously to the study participants. Remimazolam will be infused in 30 seconds to the participants, and we will wait for 2 minutes for the participants be sedated.
When a participant was not sedated in 2 minutes, dose of remimazolam in the next participant will be escalated by 0.05mg/kg. When a participant was sedated in 2 minutes, dose of remimazolam in the next participant will be decreased by 0.05mg/kg or maintained as same. The probability of decrement and maintenance will be 90% and 10% respectively. The dose of remimazolam in the first participant of the study will be 0.05mg/kg.
We will collect the results and obtain ED90 of remimazolam for loss of consciousness in children aged 2 to 8 years old.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study group | Experimental | Remimazolam administration and evaluation of sedative effect |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remimazolam besylate | Drug | Intravenous administration of predetermined dose of Byfavo for 30 seconds |
|
| Measure | Description | Time Frame |
|---|---|---|
| Loss of consciousness | Score 3 or more in the University of Michigan Sedation Scale in less than 2 minutes after administration of remimazolam besylate | From start of remimazolam administration to 2 minute after end of administration |
| Measure | Description | Time Frame |
|---|---|---|
| UMSS (University of Michigan Sedation Scale) | Serial measurement of University of Michigan Sedation Scale | From start of remimazolam administration to 2 minute after end of administration |
| Heart rate |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sang-Hwan Ji, M.D., Ph.D. | Contact | 82-2-2072-3661 | jsh1@snu.ac.kr |
| Name | Affiliation | Role |
|---|---|---|
| Jin-Tae Kim, M.D., Ph.D. | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Recruiting | Seoul | 03080 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17585216 | Background | Kilpatrick GJ, McIntyre MS, Cox RF, Stafford JA, Pacofsky GJ, Lovell GG, Wiard RP, Feldman PL, Collins H, Waszczak BL, Tilbrook GS. CNS 7056: a novel ultra-short-acting Benzodiazepine. Anesthesiology. 2007 Jul;107(1):60-6. doi: 10.1097/01.anes.0000267503.85085.c0. | |
| 28211193 | Background | Gorges M, Zhou G, Brant R, Ansermino JM. Sequential allocation trial design in anesthesia: an introduction to methods, modeling, and clinical applications. Paediatr Anaesth. 2017 Mar;27(3):240-247. doi: 10.1111/pan.13088. Epub 2017 Feb 17. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Sequential allocation to drug dosage according to result of previous participant
Not provided
Not provided
Not provided
Not provided
Serial measurement of heart rate
| From start of remimazolam administration to 2 minute after end of administration |
| Pulse oximetry | Serial measurement of pulse oximetry | From start of remimazolam administration to 2 minute after end of administration |
| Noninvasive mean blood pressure | Serial measurement of noninvasive mean blood pressure | From start of remimazolam administration to 2 minute after end of administration |
| Anesthetic depth | Serial measurement of electroencephalogram-based anesthetic depth monitoring | From start of remimazolam administration to 2 minute after end of administration |
| Apnea | Incidence of apnea after administration of remimazolam besylate | From start of remimazolam administration to 2 minute after end of administration |
| 22190555 | Background | Antonik LJ, Goldwater DR, Kilpatrick GJ, Tilbrook GS, Borkett KM. A placebo- and midazolam-controlled phase I single ascending-dose study evaluating the safety, pharmacokinetics, and pharmacodynamics of remimazolam (CNS 7056): Part I. Safety, efficacy, and basic pharmacokinetics. Anesth Analg. 2012 Aug;115(2):274-83. doi: 10.1213/ANE.0b013e31823f0c28. Epub 2011 Dec 20. |