Actively Recruiting

Phase 4
Age: 12Months - 72Months
All Genders
NCT06853431

Determination of ED50 and ED95 With Clinical Efficacy of Intranasal Dexmedetomidine Combined With Esketamine for Preoperative Sedation in Pediatric General Anesthesia

Led by Second Affiliated Hospital of Wenzhou Medical University · Updated on 2025-12-02

80

Participants Needed

2

Research Sites

39 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

For pediatric patients undergoing general anesthesia, poor anesthesia induction compliance often has adverse effects on individual behavior in the early postoperative period. Dexmedetomidine can reduce the cardiovascular responses and postoperative mental adverse reactions caused by esketamine anesthesia induction \[6\]. This study aims to explore the ED50 and ED95 and clinical effects of the combination of dexmedetomidine and esketamine nasal drops for preoperative sedation in children of different ages undergoing general anesthesia, providing a theoretical basis for the combined use of dexmedetomidine and esketamine for preoperative sedation in children undergoing general anesthesia.

CONDITIONS

Official Title

Determination of ED50 and ED95 With Clinical Efficacy of Intranasal Dexmedetomidine Combined With Esketamine for Preoperative Sedation in Pediatric General Anesthesia

Who Can Participate

Age: 12Months - 72Months
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • ASA physical status classification Grade I or II
  • Age 1 to 6 years old
  • Children scheduled for elective surgery requiring general anesthesia
  • Weight within the normal range
  • Signed informed consent form
Not Eligible

You will not qualify if you...

  • Child or guardian refuses to participate
  • Contraindications to sedation or anesthesia or history of abnormal recovery
  • Known allergy to study drugs, opioid drugs, or rescue medications
  • History of heart, brain, liver, kidney, or metabolic diseases
  • Upper respiratory tract infection within the past two weeks
  • Other diseases that may harm the participant

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

The second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China, 325000

Not Yet Recruiting

2

The second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China, 325000

Actively Recruiting

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Research Team

H

Huacheng Liu

CONTACT

C

Chenrui Zhou

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

2

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Determination of ED50 and ED95 With Clinical Efficacy of Intranasal Dexmedetomidine Combined With Esketamine for Preoperative Sedation in Pediatric General Anesthesia | DecenTrialz