Using dexmedetomidine and esketamine for sedation in young children before surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effectiveness of intranasal dexmedetomidine combined with esketamine for preoperative sedation in pediatric patients undergoing general anesthesia. Children aged 1 to 6 years are randomly assigned to two age groups, and their sedation levels are assessed using the Ramsay Sedation Scale after administering the medications. The study aims to determine the effective doses (ED50 and ED95) of these drugs to improve sedation compliance and reduce adverse postoperative effects. The methodology includes a unique dose adjustment strategy based on the sedation response of previous participants.

Why it matters

Who can join: the full rules

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. -

Where it's running

• The second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University
  Wenzhou, Zhejiang, China Recruiting
• The second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University
  Wenzhou, Zhejiang, China Not yet recruiting

Study contacts

• Principal investigator: Huacheng Liu — Second Affiliated Hospital of Wenzhou Medical University
• Study coordinator: Huacheng Liu
• Email: huachengliu@163.com
• Phone: 18957755138

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Esketamine dose levels combined with dexmedetomidine to reduce pain after scoliosis correction

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.