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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
Methods: Eighty ASA â… - â…¡ 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Esmketamine group | Active Comparator | 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 | Active Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Esmketamine,Dexmedetomidine | Drug | Two different drugs were given to observe which of the two drugs was more suitable for DISE detection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Onset time, Vital signs | Time from administration to operation;Heart rate, blood pressure and body movement during operation | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xuemin Song, professor | Contact | 18986073715 | xueminsong@whu.edu.cn | |
| Aming Sang, doctor | Contact | 15271945604 | 775661547@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Yuanzhen Zhang, professor | Wuhan University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongnan Hospital | Recruiting | Wuhan | Hubei | 430071 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36532775 | Derived | Yongping Z, Xinyi L, Aming S, Qiang X, Tianqi Z, Mengmeng S, Xiong C, Xuemin S. The safety and efficacy of esketamine in comparison to dexmedetomidine during drug-induced sleep endoscopy in children with obstructive sleep apnea hypopnea syndrome: A randomized, controlled and prospective clinical trial. Front Pharmacol. 2022 Dec 1;13:1036509. doi: 10.3389/fphar.2022.1036509. eCollection 2022. |
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| ID | Term |
|---|---|
| C535586 | Carnevale syndrome |
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| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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