Status:

RECRUITING

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

Lead Sponsor:

Second Affiliated Hospital of Wenzhou Medical University

Conditions:

Preoperative Anxiety

Preoperative Sedation

Eligibility:

All Genders

12-72 years

Phase:

PHASE4

Brief Summary

For pediatric patients undergoing general anesthesia, poor anesthesia induction compliance often has adverse effects on individual behavior in the early postoperative period. Dexmedetomidine can reduc...

Detailed Description

Children scheduled for general anesthesia were randomly divided into two groups based on age: Group T consisted of toddlers aged 1 - 3 years old, and Group P consisted of preschool children aged 3 - 6...

Eligibility Criteria

Inclusion Criteria:

  1. ASA physical status classification Grade I or II;
  2. Age 1-6 years old;
  3. Children who need to undergo general anesthesia for elective surgery;
  4. Weight within the normal range;
  5. Signed informed consent form. -

Exclusion Criteria:

  1. The child's guardian or the child themselves refuses to participate in the study;
  2. Patients with contraindications for sedation/anesthesia or a history of abnormal recovery from sedation/anesthesia;
  3. Individuals known to be allergic to the study drugs, opioid drugs, or rescue medications;
  4. Individuals with a history of heart, brain, liver, kidney, or metabolic diseases;
  5. Individuals with an upper respiratory tract infection within the past two weeks;
  6. Individuals with other diseases that may cause harm to the subject. -

Key Trial Info

Start Date :

March 1 2025

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

November 30 2025

Estimated Enrollment :

80 Patients enrolled

Trial Details

Trial ID

NCT06853431

Start Date

March 1 2025

End Date

November 30 2025

Last Update

December 2 2025

Active Locations (2)

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Page 1 of 1 (2 locations)

1

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

Wenzhou, Zhejiang, China, 325000

2

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

Wenzhou, Zhejiang, China, 325000

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