Determination of ED50 and ED95 With Clinical Efficacy of Intranasal Dexmedetomidine Combined With Esketamine for Preoperative Sedation in Pediatric General Anesthesia
Second Affiliated Hospital of Wenzhou Medical University
Phase
Phase 4
Started
2025-03-01
Last updated
2025-12-02
Condition(s) studied
Preoperative AnxietyPreoperative SedationChildrenDexmedetomidineEsketamineED95ED50Preoperative Sedation of Children
Investigational drug(s) / intervention(s)
dexmedetomidineEsketamine
dexmedetomidine: 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.
Esketamine: 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.
Study 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.
Eligibility
Sex
ALL
Min age
12 Months
Max age
72 Months
Healthy volunteers
No
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. -
Primary outcome measure(s)
Onset time of sedation — Within 30 minutes after intranasal administration of dexmedetomidine. 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.
Trial sites (2)
Facility
City
Region
Status
The second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University
Wenzhou
Zhejiang
Not Yet Recruiting
The second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University
Wenzhou
Zhejiang
Recruiting
More Second Affiliated Hospital of Wenzhou Medical University trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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