Safety and Efficacy of Esmketamine Versus Dexmedetomidine
Primary Purpose
Osa Syndrome
Status
Recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Esmketamine,Dexmedetomidine
Sponsored by
About this trial
This is an interventional other trial for Osa Syndrome focused on measuring pediatrics ;Osa Syndrome
Eligibility Criteria
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.
Sites / Locations
- Zhongnan HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Esmketamine group
Dexmedetomidine group
Arm Description
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 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
Outcomes
Primary Outcome Measures
Onset time, Vital signs
Time from administration to operation;Heart rate, blood pressure and body movement during operation
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04877639
Brief Title
Safety and Efficacy of Esmketamine Versus Dexmedetomidine
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2021 (Actual)
Primary Completion Date
December 1, 2022 (Anticipated)
Study Completion Date
May 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zhongnan Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osa Syndrome
Keywords
pediatrics ;Osa Syndrome
7. Study Design
Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Sequential Assignment
Masking
Participant
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Esmketamine group
Arm Type
Active Comparator
Arm Description
Intravenous injection of 1.0mg/kg esmketamine was given, and nasal endoscopy was started 3 minutes later to maintain 1.0mg/kg/h esmketamine
Arm Title
Dexmedetomidine group
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Esmketamine,Dexmedetomidine
Intervention Description
Two different drugs were given to observe which of the two drugs was more suitable for DISE detection
Primary Outcome Measure Information:
Title
Onset time, Vital signs
Description
Time from administration to operation;Heart rate, blood pressure and body movement during operation
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xuemin Song, professor
Phone
18986073715
Email
xueminsong@whu.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Aming Sang, doctor
Phone
15271945604
Email
775661547@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yuanzhen Zhang, professor
Organizational Affiliation
Wuhan University
Official's Role
Study Chair
Facility Information:
Facility Name
Zhongnan Hospital
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430071
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xuemin Song, professor
Phone
18986073715
Email
xueminsong@whu.edu.cn
First Name & Middle Initial & Last Name & Degree
Aming Sang, doctor
Phone
15271945604
Email
775661547@qq.com
12. IPD Sharing Statement
Plan to Share IPD
No
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Safety and Efficacy of Esmketamine Versus Dexmedetomidine
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