Determination of ED50 and ED95 With Clinical Efficacy of Intranasal Dexmedetomidine Combined With… (NCT06853431) | Clinical Trial Compass
RecruitingPhase 4
Determination of ED50 and ED95 With Clinical Efficacy of Intranasal Dexmedetomidine Combined With Esketamine for Preoperative Sedation in Pediatric General Anesthesia
China80 participantsStarted 2025-03-01
Plain-language 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.
Who can participate
Age range12 Months – 72 Months
SexALL
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Inclusion criteria
✓. 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. -
Exclusion criteria
✕. 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;
What they're measuring
1
Onset time of sedation
Timeframe: Within 30 minutes after intranasal administration of dexmedetomidine.
Trial details
NCT IDNCT06853431
SponsorSecond Affiliated Hospital of Wenzhou Medical University