Safety and Efficacy of Esmketamine Versus Dexmedetomidine
- Conditions
- Osa Syndrome
- Interventions
- Drug: Esmketamine,Dexmedetomidine
- Registration Number
- NCT04877639
- Lead Sponsor
- Zhongnan Hospital
- 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 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 80
- 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.
- ASA grade III and above, abnormal heart, lung, liver and kidney function before operation; There were central nervous system diseases and mental diseases, preoperative allergy to anesthetics (dexmedetomidine, esmketamine), family history of malignant high fever, tracheostomy and other artificial airway.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Esmketamine group Esmketamine,Dexmedetomidine Intravenous injection of 1.0mg/kg esmketamine was given, and nasal endoscopy was started 3 minutes later to maintain 1.0mg/kg/h esmketamine Dexmedetomidine group Esmketamine,Dexmedetomidine Dexmedetomidine 1 μg/ kg at least 10 min after intravenous injection + maintain 1 μ After intravenous injection of dexmedetomidine 1 ug / kg, sufentanil 0.05 mg / kg was given 5 minutes
- Primary Outcome Measures
Name Time Method Onset time, Vital signs 1 year Time from administration to operation;Heart rate, blood pressure and body movement during operation
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Zhongnan Hospital
🇨🇳Wuhan, Hubei, China