Clinical trial NCT06853431: Determination of ED50 and ED95 With Clinical Efficacy of Intranasal Dexmedetomidine Combined With Esketamine for Preoperative Sedation in Pediatric General Anesthesia
Official title: Determination of ED50 and ED95 With Clinical Efficacy of Intranasal Dexmedetomidine Combined With Esketamine for Preoperative Sedation in Pediatric General Anesthesia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
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
Lead sponsor: Second Affiliated Hospital of Wenzhou Medical University
Sponsor class: OTHER
First posted: 2025-03-03
Enrollment: 80
Sex: ALL
Minimum age (years): 12
Maximum age (years): 72
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.

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 years old. The initial dose for both groups was dexmedetomidine 1μg/kg and esketamine 0.5mg/kg.

The sedation depth of the children was assessed using the Ramsay Sedation Scale. An unbiased coin - flipping design was adopted: after esketamine 0.5mg/kg was administered intranasally via a nasal dropper, dexmedetomidine 1μg/kg was given intranasally. The adjusted dose of dexmedetomidine was 0.25μg/kg. If the sedation of the previous child failed, the intranasal dose of dexmedetomidine for the next child would be increased by 0.25μg/kg. If the sedation of the previous child was successful, a card would be drawn to decide the induction dose for the next patient. A total of 20 cards, which were identical in appearance, were prepared. The probability of administering the same dose was 19/20 (95%), and the probability of reducing the dose for the next patient by 0.25μg/kg was 1/20 (5%).

After drug administration, an anesthesiologist who was unaware of the medication usage would rate the sedation level using the Ramsay Sedation Scale every 5 minutes. The non - invasive blood pressure (NIBP), heart rate (HR), respiratory rate (RR), and blood oxygen saturation (SpO2) were recorded before drug administration (0 minutes, baseline) and at 5, 10, 15, 20, 25, and 30 minutes after drug administration. The Parental Separation Anxiety Scale (PSAS) was used to assess separation anxiety 30 minutes after drug administration. The Inhalation Induction Compliance Scale (ICC) was used to evaluate the patient's compliance with anesthesia induction after entering the operating room. The Pediatric Anesthesia Emergence Delirium (PAED) scale was used to assess the degree of emergence delirium in children. The onset time of sedation (the time to reach an RSS score of ≥4 after intranasal drug administration), surgical time (from the start to the end of the surgery), and awakening time (from the closure of the sevoflurane vaporizer to an Aldrete score of 9 or above) were recorded.

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. -

Primary outcomes:
measure: Onset time of sedation
timeFrame: Within 30 minutes after intranasal administration of dexmedetomidine.
Secondary outcomes:
measure: Parent - child separation anxiety score
timeFrame: 30 minutes after intranasal administration of dexmedetomidine.
measure: Induction Compliance Score
timeFrame: 3 minutes after entering the operating room.
measure: Awakening time
timeFrame: Within 1 hour of entering the Post Anesthesia Care Unit (PACU).
measure: Postoperative agitation
timeFrame: Within up to 15-30 minutes after child's first eye opening in the postoperative period
measure: Number of children with adverse effects
timeFrame: Up to 24 hours including preoperative, intraoperative, and postoperative periods
Other outcomes:
Locations:
city: Wenzhou
country: China
facility: The second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University
state: Zhejiang
city: Wenzhou
country: China
facility: The second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University
state: Zhejiang
Study officials:
affiliation: Second Affiliated Hospital of Wenzhou Medical University
name: Huacheng Liu
role: PRINCIPAL_INVESTIGATOR
References: