Determination of ED50 and ED95 With Clinical Efficacy of Intranasal Dexmedetomidine Combined With Esketamine for Preoperative Sedation in Pediatric General Anesthesia

Launched by SECOND AFFILIATED HOSPITAL OF WENZHOU MEDICAL UNIVERSITY · Feb 27, 2025

Keywords

ClinConnect Summary

This clinical trial is studying how effective and safe a combination of two medications, dexmedetomidine and esketamine, is for helping children feel calm before undergoing surgery with general anesthesia. The researchers want to find out the right doses of these medications to help children relax without causing unwanted side effects. By understanding how these medications work together, the goal is to improve the experience for kids and reduce any anxiety they might feel before their procedures.

To participate in this study, children must be between the ages of 1 and 6 years and need to have surgery that requires general anesthesia. They should be in good health overall, without serious medical conditions or allergies to the medications being tested. Parents or guardians will need to give their permission for their child to join the study. If eligible, your child will receive the nasal drops as part of the preoperative care, and the doctors will monitor their response to ensure they're comfortable and safe throughout the process.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. ASA physical status classification Grade I or II;
• • 2. Age 1-6 years old;
• • 3. Children who need to undergo general anesthesia for elective surgery;
• • 4. Weight within the normal range;
• • 5. Signed informed consent form. -
• Exclusion Criteria:
• • 1. The child's guardian or the child themselves refuses to participate in the study;
• • 2. Patients with contraindications for sedation/anesthesia or a history of abnormal recovery from sedation/anesthesia;
• • 3. Individuals known to be allergic to the study drugs, opioid drugs, or rescue medications;
• • 4. Individuals with a history of heart, brain, liver, kidney, or metabolic diseases;
• • 5. Individuals with an upper respiratory tract infection within the past two weeks;
• • 6. Individuals with other diseases that may cause harm to the subject. -