About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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;
Trial design
Sequential
Treatments tested in this trial
dexmedetomidine
Drugesketamine 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
Drugesketamine 0.5mg/kg intranasally via a nasal dropper, dexmedetomidine 1μg/kg was given intranasally, and the adjusted dose of dexmedetomidine was 0.25μg/kg.
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
Intravenous cannulation success rates
Emotional State Score 1. Calm 2. Apprehensive, not smiling, tentative behavior, withdrawn 3. Crying 4. Thrashing, crying with movements of the arms and legs, resisting
Awakening time
From the closure of the sevoflurane vaporizer to the time when the patient opened their eyes.
Postoperative agitation
The pediatric anesthesia emergence delirium scale consists of five items. Each item is scored 0-4 yielding a total between 0 and 20. The degree of emergence delirium increased directly with the total score. pediatric anesthesia emergence delirium scale ≥12 at any time indicates presence of emergence delirium.
Number of children with adverse effects
1、Bradycardia and/or hypotension need for hemodynamic support; 2、Desaturation is defined as Oxygen desaturation \<90%; 3、Nausea and vomiting; 4、Any adverse effects requiring interventions.
Sponsors and contacts
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