search
Back to results

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
Zhongnan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Osa Syndrome focused on measuring pediatrics ;Osa Syndrome

Eligibility Criteria

3 Years - 12 Years (Child)All SexesAccepts Healthy Volunteers

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

First Posted
May 4, 2021
Last Updated
August 19, 2022
Sponsor
Zhongnan Hospital
search

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

Learn more about this trial

Safety and Efficacy of Esmketamine Versus Dexmedetomidine

We'll reach out to this number within 24 hrs