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

NCT06853431 | Recruiting Phase 4 DMC

• 1 other identifier: SAHoWMU-CR2025-03-105
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

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 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

Preoperative Anxiety; Preoperative Sedation; Children; Dexmedetomidine; Esketamine; ED95; ED50; Preoperative Sedation of Children

Keywords

Preoperative Anxiety; Preoperative sedation; Children; Dexmedetomidine; Esketamine; ED95; ED50; preoperative sedation of children

Outcome Measures

Primary Outcomes (1)

• Onset time of sedation

  After drug administration, every 5 minutes, an anesthesiologist who was unaware of the medication used assessed the sedation level using the Ramsay Sedation Scale(RSS).Within 30 minutes after the intranasal medication was administered, the Ramsay Sedation Score (RSS) was ≥4.

  Within 30 minutes after intranasal administration of dexmedetomidine.

Secondary Outcomes (4)

• Intravenous cannulation success rates

  30 minutes after intranasal administration of dexmedetomidine.

• Awakening time

  Within 1 hour of entering the Post Anesthesia Care Unit (PACU).

• Postoperative agitation

  Within up to 15-30 minutes after child's first eye opening in the postoperative period

• Number of children with adverse effects

  Up to 24 hours including preoperative, intraoperative, and postoperative periods

Study Arms (2)

1-3 years old

EXPERIMENTAL

The sedation depth of the children was assessed using the Ramsay Sedation Scale. This study was conducted using the biased coin design up - and - down method. The dose for the subsequent participant was determined based on the response of the previous participant. If the previous participant achieved successful sedation, the next participant had a 95% probability of receiving the same dose of dexmedetomidine as the previous participant and a 5% probability of receiving a lower dose of dexmedetomidine (a dose reduction of 0.25 µg/kg). If the previous participant failed to achieve sedation, the dose of dexmedetomidine for the next participant was increased by 0.25 µg/kg until the number of participants reached 40.

Drug: dexmedetomidine; Drug: Esketamine

3-6 years old

EXPERIMENTAL

The sedation depth of the children was assessed using the Ramsay Sedation Scale. This study was conducted using the biased coin design up - and - down method. The dose for the subsequent participant was determined based on the response of the previous participant. If the previous participant achieved successful sedation, the next participant had a 95% probability of receiving the same dose of dexmedetomidine as the previous participant and a 5% probability of receiving a lower dose of dexmedetomidine (a dose reduction of 0.25 µg/kg). If the previous participant failed to achieve sedation, the dose of dexmedetomidine for the next participant was increased by 0.25 µg/kg until the number of participants reached 40.

Drug: dexmedetomidine; Drug: Esketamine

Interventions

dexmedetomidine DRUG

esketamine 0.5mg/kg intranasally via a nasal dropper, dexmedetomidine 1μg/kg was given intranasally, and the adjusted dose of dexmedetomidine was 0.25μg/kg.

1-3 years old; 3-6 years old

Esketamine DRUG

esketamine 0.5mg/kg intranasally via a nasal dropper, dexmedetomidine 1μg/kg was given intranasally, and the adjusted dose of dexmedetomidine was 0.25μg/kg.

1-3 years old; 3-6 years old

Eligibility Criteria

• Age: 12 Months - 72 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Second Affiliated Hospital of Wenzhou Medical University: lead

Study Sites (2)

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

Wenzhou, Zhejiang, 325000, China

NOT YET RECRUITING

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

Wenzhou, Zhejiang, 325000, China

RECRUITING

MeSH Terms

Interventions

Dexmedetomidine; Esketamine

Intervention Hierarchy (Ancestors)

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

Study Officials

• Huacheng Liu

  Second Affiliated Hospital of Wenzhou Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Huacheng Liu

CONTACT

18957755138; huachengliu@163.com

Chenrui Zhou

CONTACT

15157910160; zcr934419@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2025
• First Posted: March 3, 2025
• Study Start: March 1, 2025
• Primary Completion: November 30, 2025
• Study Completion: November 30, 2025
• Last Updated: December 2, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)