Safety and Efficacy of Esmketamine Versus Dexmedetomidine

Osa Syndrome Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04877639
• Other study ID #: XM Song
• Status: Recruiting
• Phase: Phase 4
• Start date: May 1, 2021
• Est. completion date: May 1, 2023

Study information

• Verified date: August 2022
• Source: Zhongnan Hospital
• Contact: Xuemin Song, professor
• Phone: 18986073715
• Email: xueminsong[@]whu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: May 1, 2023
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 12 Years

Eligibility

Inclusion Criteria:

• Eighty ASA ? - ? 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.

Related Conditions & MeSH terms

• Osa Syndrome
• Syndrome

Intervention

Drug:
• Esmketamine,Dexmedetomidine
Two different drugs were given to observe which of the two drugs was more suitable for DISE detection

Locations

Country	Name	City	State
China	Zhongnan Hospital	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Zhongnan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Onset time, Vital signs	Time from administration to operation;Heart rate, blood pressure and body movement during operation	1 year