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Comparing Two Doses of Midazolam With Added Dexmedetomidine for Kids Before Surgery

StatusCompleted
PhasePhase 2
Started
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Record History

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  1. Notable Primary completion date changed from estimate of Sep 2025 to May 1, 2026 Show 7 more changesShow less
    • Completed without a posted recruiting period
    • Study sites: 2 to 1
    • Study completion date changed from estimate of Dec 2025 to Jun 1, 2026
    • Interventions: Dexmedetomidine + Midazolam 0.2 mg/kg (Drug), Dexmedetomidine + Midazolam 0.4 mg/kg (Drug) to Dexmedetomidine + Midazolam 0.2 mg/kg (Drug), Dexmedetomidine + Midazolam 0.4 mg/kg (Drug)
    • Eligibility criteria expanded, about 23 words
    • Secondary endpoints: 6 to 7
    • Publications: details revised at 5 of 6 entries
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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The goal of this randomized controlled trial is to investigate if adding intranasal dexmedetomidine to two different doses of intranasal midazolam provides effective sedation with fewer side effects in pediatric patients aged 1 to 8 years undergoing elective surgeries. The main questions it aims to answer are: Does combining intranasal dexmedetomidine with a reduced dose of midazolam achieve adequate sedation while minimizing adverse effects? How do different dosing regimens affect mask acceptance, parent separation, sedation levels, recovery times, and perioperative adverse events? Researchers will compare two groups: one receiving dexmedetomidine plus a higher dose of midazolam (0.4 mg/kg) and another receiving dexmedetomidine plus a lower dose of midazolam (0.2 mg/kg) to see if the reduced dose maintains sedation effectiveness while reducing side effects. Participants will: Receive intranasal dexmedetomidine (2 mcg/kg) combined with either 0.4 mg/kg or 0.2 mg/kg of intranasal midazolam. Undergo sedation scoring at 15 and 30 minutes after drug administration. Be assessed for ease of separation from parents and acceptance of anesthesia mask. Be monitored for vital signs, recovery times, and any perioperative adverse events.
Trial Details
NCT Number NCT06979791
Lead Sponsor Cairo University
Conditions
(from sponsor)
Preoperative Anxiety Experienced by the Pediatric Patient, Preoperative Anxiety
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov