Safety and Efficacy of Esmketamine Versus Dexmedetomidine

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-01

Study Completion Date

2023-05-01

Brief Summary

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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

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Detailed Description

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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

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Osa Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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Esmketamine group

Intravenous injection of 1.0mg/kg esmketamine was given, and nasal endoscopy was started 3 minutes later to maintain 1.0mg/kg/h esmketamine

Group Type ACTIVE_COMPARATOR

Esmketamine,Dexmedetomidine

Intervention Type DRUG

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

Dexmedetomidine group

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

Group Type ACTIVE_COMPARATOR

Esmketamine,Dexmedetomidine

Intervention Type DRUG

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

Interventions

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Esmketamine,Dexmedetomidine

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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

3 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes