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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
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04877639
Enrollment
80
Registered
2021-05-07
Start date
2021-05-01
Completion date
2023-05-01
Last updated
2022-08-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osa Syndrome

Keywords

pediatrics ;Osa Syndrome

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.

Interventions

DRUGEsmketamine,Dexmedetomidine

Two different drugs were given to observe which of the two drugs was more suitable for DISE detection

Sponsors

Zhongnan Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
OTHER
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
3 Years to 12 Years
Healthy volunteers
Yes

Inclusion criteria

* 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.

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Onset time, Vital signs1 yearTime from administration to operation;Heart rate, blood pressure and body movement during operation

Countries

China

Contacts

Primary ContactXuemin Song, professor
xueminsong@whu.edu.cn18986073715
Backup ContactAming Sang, doctor
775661547@qq.com15271945604

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026