NCT06579937 Effects of Esketamine on Postoperative Behavioral Changes in Children Undergoing Tonsillectomy and/or Adenoidectomy
| NCT ID | NCT06579937 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Fujian Provincial Hospital |
| Condition | Behavior Problem |
| Study Type | INTERVENTIONAL |
| Enrollment | 172 participants |
| Start Date | 2024-09-02 |
| Primary Completion | 2025-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 172 participants in total. It began in 2024-09-02 with a primary completion date of 2025-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this clinical trial is to learn the effect of intravenous esketamine in postoperative negative behavior changes in children compared to placebo (a look-alike substance that contains no drug). It will also learn about the effect of esketamine in emergence delirium. The main questions are: Dose esketamine lower the incidence of postoperative negative behavior changes compared to placebo? Dose esketamine lower the incidence of emergence delirium compared to placebo? Researchers will compare esketamine to placebo to see if esketamine works to treat postoperative negative behavior change and emergence delirium. Participants will: Receive intravenous esketamine or placebo (a look-alike substance that contains no drug) during anesthesia induction; Fill in the Post hospitalization behavior questionnaire for ambulatory surgery postoperative 1, 7, and 30
Eligibility Criteria
Inclusion Criteria: * American society of Aneshesiologists physical status I or II; * Aged 3-7 years; * Scheduled for elective tonsillectomy and (or) adenoidectomy. Exclusion Criteria: * Parents refusing to allow their children to participate; * Intake of sedative or analgesic medication within 48 hours before surgery; * Developmental delay; * Psychosis; * Body mass index \> 30 kg/m2; * Allergy to study drugs; * Major life changes 1 month before the operation, such as the divorce of parents, death of parents, moving to a new home, changing to a new kindergarten, etc.; * Any other conditions that precluded study inclusion.
Contact & Investigator
Xiaochun Zheng, MD
STUDY CHAIR
Fujian Provincial Hospital
Frequently Asked Questions
Who can join the NCT06579937 clinical trial?
This trial is open to participants of all sexes, aged 3 Years or older, up to 7 Years, studying Behavior Problem. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06579937 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06579937 currently recruiting?
Yes, NCT06579937 is actively recruiting participants. Contact the research team at fjslyys@fjmu.edu.cn for enrollment information.
Where is the NCT06579937 trial being conducted?
This trial is being conducted at Fuzhou, China.
Who is sponsoring the NCT06579937 clinical trial?
NCT06579937 is sponsored by Fujian Provincial Hospital. The principal investigator is Xiaochun Zheng, MD at Fujian Provincial Hospital. The trial plans to enroll 172 participants.