Effects of Nasal Administration of Dexmedetomidine on Pre-anesthesia Sedation, Intraoperative Brain Electrical Activity, and Incidence of Agitation During Recovery in Children

Launched by FUZHOU HUA · Mar 19, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a nasal spray called dexmedetomidine on young children who are about to have minor surgeries. The goal is to see if this spray can help reduce anxiety before surgery and prevent agitation when the child wakes up afterward. The trial will include 627 children aged 2 to 6 years who are in good health and are expected to have surgeries lasting no more than 2 hours. Parents or guardians must agree to let their children participate and sign a consent form.

During the trial, children will receive either the dexmedetomidine spray or a normal saline (saltwater) spray 30 minutes before their surgery. Researchers will assess how anxious and calm the children are before the surgery, monitor their brain activity during the procedure, and check for any agitation or discomfort after waking up. They will also keep a close eye on any side effects that might occur. This study aims to ensure that pediatric anesthesia is safe and comfortable for children undergoing surgery.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 2≤ age ≤6 years old, gender is not limited;
• • ASA anesthesia grade I \~ II; ③ For children who intend to undergo minor surgery under general anesthesia (including but not limited to minor surgery such as ENT surgery and hernia surgery), the operation duration is expected to be no more than 2 hours; ④ Family members agree to participate in the study and voluntarily sign informed consent;
• Exclusion Criteria:
• • Respiratory tract infection occurs within 4 weeks before surgery;
• • Potential or other contraindications to general anesthesia;
• • There are nasal diseases, nasal bleeding, sinusitis, nasal polyps and other conditions that affect nasal absorption; ④ Heart, liver, kidney and other vital organ dysfunction or blood system diseases;
• • Allergy or intolerance to dexmedetomidine or other α2-adrenergic receptor agonists;
• • Patients with mental illness or neurological diseases;
• • Unable to complete the test, the child's guardian refused to participate; ⑧ Have participated in other clinical trials or need to participate in other clinical trials during the study period; ⑨ Other reasons that the researchers consider inappropriate to participate in this study.