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Search / Trial NCT06979791

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

Launched by CAIRO UNIVERSITY · May 16, 2025

Trial Information

Current as of July 23, 2025

Not yet recruiting

Keywords

"Pediatric Premedication" "Dexmedetomidine" "Midazolam" "Sedation" "Mask Acceptance"

ClinConnect Summary

This clinical trial is studying how well a combination of medications can help young children feel calm and relaxed before surgery. Researchers want to see if adding a medicine called dexmedetomidine to two different doses of another medicine, midazolam, can provide effective sedation (helping kids relax) while also reducing side effects. Children aged 1 to 8 who are scheduled for short surgeries (lasting less than an hour) may be eligible to participate.

If your child takes part in this study, they will receive a nasal spray of dexmedetomidine along with either a higher or lower dose of midazolam. The researchers will monitor how well the medications work and how your child responds during the process, including how easily they accept wearing an anesthesia mask and how they separate from you. They will also keep track of any side effects and how quickly your child recovers after the procedure. This trial is not yet recruiting participants, but it's an important step toward improving care for children undergoing surgery.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Pediatric patients aged 1 to 8 years
  • Scheduled for elective surgery under general anesthesia
  • Surgery duration \< 1 hour
  • ASA physical status I or II
  • Parent or legal guardian able to provide informed consent
  • Exclusion Criteria:
  • Refusal to participate by parent/guardian
  • Nasal infections, pathology, or epistaxis
  • Runny nose or upper respiratory tract infection
  • Enlarged adenoids
  • BMI \> 30
  • Known allergy to dexmedetomidine or midazolam
  • Fever on day of surgery
  • Coagulopathy
  • Scheduled for cardiothoracic or neurosurgical procedures
  • Congenital heart disease
  • Neurological or mental disorders
  • Pre-existing sedation (MOASS \< 5) on the day of surgery

About Cairo University

Cairo University, a premier institution in Egypt, is dedicated to advancing medical research and education through innovative clinical trials. With a strong emphasis on improving healthcare outcomes, the university collaborates with various stakeholders to conduct rigorous scientific studies that address critical health challenges. Leveraging its extensive resources and expert faculty, Cairo University aims to contribute valuable insights to the medical community and enhance patient care both locally and globally. Through its commitment to ethical research practices and excellence, the university plays a pivotal role in shaping the future of healthcare in the region.

Locations

Cairo, , Egypt

Giza, , Egypt

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported