Safety and Efficacy of Esmketamine Versus Dexmedetomidine

NCT04877639 | Unknown Phase 4 DMC

• 1 other identifier: XM Song
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Conditions

Osa Syndrome

Keywords

pediatrics ;Osa Syndrome

Outcome Measures

Primary Outcomes (1)

• Onset time, Vital signs

  Time from administration to operation;Heart rate, blood pressure and body movement during operation

  1 year

Study Arms (2)

Esmketamine group

ACTIVE COMPARATOR

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

Drug: Esmketamine,Dexmedetomidine

Dexmedetomidine group

ACTIVE COMPARATOR

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

Drug: Esmketamine,Dexmedetomidine

Interventions

Esmketamine,Dexmedetomidine DRUG

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

Dexmedetomidine group; Esmketamine group

Eligibility Criteria

• Age: 3 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhongnan Hospital: lead

Study Sites (1)

Zhongnan Hospital

Wuhan, Hubei, 430071, China

RECRUITING

Related Publications (1)

• Yongping Z, Xinyi L, Aming S, Qiang X, Tianqi Z, Mengmeng S, Xiong C, Xuemin S. The safety and efficacy of esketamine in comparison to dexmedetomidine during drug-induced sleep endoscopy in children with obstructive sleep apnea hypopnea syndrome: A randomized, controlled and prospective clinical trial. Front Pharmacol. 2022 Dec 1;13:1036509. doi: 10.3389/fphar.2022.1036509. eCollection 2022.

  PMID: 36532775 DERIVED

MeSH Terms

Conditions

Carnevale syndrome

Interventions

Dexmedetomidine

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Yuanzhen Zhang, professor

  Wuhan University

  STUDY CHAIR

Central Study Contacts

Xuemin Song, professor

CONTACT

18986073715; xueminsong@whu.edu.cn

Aming Sang, doctor

CONTACT

15271945604; 775661547@qq.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor

Study Record Dates

• First Submitted: May 4, 2021
• First Posted: May 7, 2021
• Study Start: May 1, 2021
• Primary Completion: December 1, 2022
• Study Completion: May 1, 2023
• Last Updated: August 22, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)