Ignite Creation Date:
2024-05-06 @ 4:06 PM
Last Modification Date:
2024-10-26 @ 2:04 PM
Study NCT ID:
NCT04877639
Status:
UNKNOWN
Last Update Posted:
2022-08-22
First Post:
2021-05-04
Brief Title:
Safety and Efficacy of Esmketamine Versus Dexmedetomidine
Sponsor:
Zhongnan Hospital
Organization:
Zhongnan Hospital
Study Overview
Official Title:
A Comparative Study on the Safety and Efficacy of Esmketamine Versus Dexmedetomidine During Drug Induced Sleep Endoscopy in Children With Positional Obstructive Sleep Apnea A Consort-prospective Randomized Controlled Clinical Trial
Status:
UNKNOWN
Status Verified Date:
2022-08
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A comparative study on the safety and efficacy of esmketamine versus Dexmedetomidine during drug induced sleep endoscopy in children with positional obstructive sleep apnea A consort-prospective randomized controlled clinical trial
Detailed Description:
Methods Eighty ASA Ⅰ - Ⅱ patients aged 3-13 years underwent elective surgery under general anesthesia No serious cardiovascular disease no liver and kidney dysfunction no central nervous system disease and mental disease Patients undergoing tonsillectomy under general anesthesia were selected as the research objects
80 patients were randomly divided into dexmedetomidine group D n 40 and ketamine Group K n 40 Both groups were given midazolam 02mgkg intravenously
Group K induction intravenous injection of 10mgkg esmketamine nasal endoscopy started 3 minutes later maintained 10mgkgh esmketamine
Group D induction Dexmedetomidine 1 μ G kg at least 10 min after intravenous injection maintain 1 μ After 5 minutes of intravenous injection of dexmedetomidine 1 ug kg sufentanil 005 mg kg was given
Propofol 05 mg kg-1 was injected intravenously when the patient had body movement
Heart rate HR mean arterial pressure map electrocardiogram ECG respiratory rate RR pulse oxygen saturation SpO2 and BIS were recorded before T1 during T2 after T3 1 min after tracheal intubation T4 1 min after extubation T5 and 30 min after extubation T6
32 onset and maintenance time the time from administration to endoscopic examination min Recovery time min
33 observation and treatment of adverse reactions during and after dis
34 observe the sedation score of the two groups during the dis phase and the awake score 30 minutes after waking up
Objective To observe the application of dexmedetomidine and esmketamine in drug-induced sleep nasal endoscopy and to explore the best medication scheme so as to better guide clinical medication
80 patients were randomly divided into dexmedetomidine group D n 40 and ketamine Group K n 40 Both groups were given midazolam 02mgkg intravenously
Group K induction intravenous injection of 10mgkg esmketamine nasal endoscopy started 3 minutes later maintained 10mgkgh esmketamine
Group D induction Dexmedetomidine 1 μ G kg at least 10 min after intravenous injection maintain 1 μ After 5 minutes of intravenous injection of dexmedetomidine 1 ug kg sufentanil 005 mg kg was given
Propofol 05 mg kg-1 was injected intravenously when the patient had body movement
Heart rate HR mean arterial pressure map electrocardiogram ECG respiratory rate RR pulse oxygen saturation SpO2 and BIS were recorded before T1 during T2 after T3 1 min after tracheal intubation T4 1 min after extubation T5 and 30 min after extubation T6
32 onset and maintenance time the time from administration to endoscopic examination min Recovery time min
33 observation and treatment of adverse reactions during and after dis
34 observe the sedation score of the two groups during the dis phase and the awake score 30 minutes after waking up
Objective To observe the application of dexmedetomidine and esmketamine in drug-induced sleep nasal endoscopy and to explore the best medication scheme so as to better guide clinical medication
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None