NCT04877639

Safety and Efficacy of Esmketamine Versus Dexmedetomidine

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
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Zhongnan Hospital · Academic / Other
• Sex: All
• Age: 3 Years – 12 Years
• Healthy volunteers: Accepted

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 0.2mg/kg intravenously Group K: induction: intravenous injection of 1.0mg/kg esmketamine, nasal endoscopy started 3 minutes later, maintained 1.0mg/kg/h 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 0.05 mg / kg was given. Propofol 0.5 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). 3.2 onset and maintenance time: the time from administration to endoscopic examination (min); Recovery time (min) 3.3 observation and treatment of adverse reactions during and after dis 3.4 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.

Conditions

• Osa Syndrome

Interventions

Type	Name	Description
DRUG	Esmketamine,Dexmedetomidine	Two different drugs were given to observe which of the two drugs was more suitable for DISE detection

Timeline

• Start date: 2021-05-01
• Primary completion: 2022-12-01
• Completion: 2023-05-01
• First posted: 2021-05-07
• Last updated: 2022-08-22

Locations

1 site across 1 country: China