Using dexmedetomidine and esketamine for sedation in young children before surgery
Determination of ED50 and ED95 With Clinical Efficacy of Intranasal Dexmedetomidine Combined With Esketamine for Preoperative Sedation in Pediatric General Anesthesia
This study tests if a combination of two medications, dexmedetomidine and esketamine, can help young children feel calm and relaxed before surgery.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 12 Months to 72 Months |
| Sex | All |
| Sponsor | Second Affiliated Hospital of Wenzhou Medical University Academic / other |
| Locations | 2 sites (Wenzhou, Zhejiang and 1 other locations) |
| Trial ID | NCT06853431 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are children aged 1 to 6 years who require general anesthesia for elective surgery and have no contraindications for sedation.
Not a fit: Patients with a history of adverse reactions to sedation or those with significant medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance sedation effectiveness and safety for young children undergoing surgery.
How similar studies have performed: While the combination of dexmedetomidine and esketamine is being explored, similar studies have shown promise in improving sedation outcomes in pediatric anesthesia.
Eligibility criteria
Show full inclusion / exclusion 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. -
Where this trial is running
Wenzhou, Zhejiang and 1 other locations
- The second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University — Wenzhou, Zhejiang, China (Not_yet_recruiting)
- The second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University — Wenzhou, Zhejiang, China (Recruiting)
Study contacts
- Principal investigator: Huacheng Liu — Second Affiliated Hospital of Wenzhou Medical University
- Study coordinator: Huacheng Liu
- Email: huachengliu@163.com
- Phone: 18957755138
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.