Evaluating clonidine to reduce emergence agitation in young children

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 efficacy and safety of a single dose of intraoperative clonidine in children aged 3 to 12 months undergoing general anesthesia with sevoflurane. It is a randomized, placebo-controlled study designed to assess the impact of clonidine on emergence agitation, a common postoperative complication characterized by behavioral disturbances. The trial will also evaluate the pharmacokinetics of clonidine in this pediatric population. Participants will be closely monitored for safety and effectiveness throughout the study.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Paediatric patients (male and female), aged 3- ≤ 12 months
* Scheduled general anaesthesia with sevoflurane and opioid. Induction with propofol is optional
* The legally acceptable representative for the study participant provides written informed consent/assent for the trial

Exclusion Criteria:

* ASA \>2
* Cardiac, neuro and trauma surgery
* Ex-premature (\<37 weeks) • Premedication with clonidine
* Intubated prior to scheduled anaesthesia or is expected to require intubation after the procedure
* Critical illness incl. hemodynamic instability (inotropic drugs needed)
* Bleeding requiring transfusion prior to scheduled anaesthesia
* Planned for a postoperative nurse-controlled analgesia pump including a continuous infusion of opioid
* Malignant disease
* Cardiac disease incl. arrhythmia
* Chronic lung disease that may influence study results or study participation in the opinion of the Investigator or may comprise safety and well-being of the patient
* Mental retardation
* Neurological disease including symptoms similar to emergence agitation
* Has or is suspected of having a family or personal history of malignant hyperthermia
* Has or is suspected of having an allergy to study treatment or its excipients
* Any condition that can in opinion of the Investigator, deteriorate safety and well-being of the patients or interfere with pharmacokinetic data
* Positive Covid-19 test or clinical suspicion of Covid-19 (according to current local guidelines)

Where it's running

• Perth Children's Hospital, Department of Anaesthesia and Pain Medicine
  Perth, Nedlands, Australia Recruiting
• Copenhagen University Hospital, Rigshospitalet
  Copenhagen, Denmark Recruiting

Study contacts

• Principal investigator: Arash Afshari, PhD — Copenhagen University Hospital, Rigshospitalet
• Study coordinator: Bettina Nielsen, PhD
• Email: bettina.nygaard.nielsen@regionh.dk
• Phone: +4535459546

Similar studies

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

• Live parent-child video interaction or cartoon watching to ease emergence agitation in preschoolers

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• Oral vs IV Magnesium for Emergence Delirium in Children after Adenotonsillectomy

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• Greater auricular nerve block to reduce agitation after children's middle ear surgery

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  Recruiting Fayoum University · Al Fayyum, Faiyum Governorate · NCT07435675

• Dexmedetomidine–midazolam versus ketamine–midazolam for emergence delirium in children

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• Remimazolam with sevoflurane to reduce wake-up agitation in children after neurosurgery.

  This trial will test whether adding a single bolus of remimazolam to sevoflurane anesthesia lowers the chance that children ages 1–6 become agitated as they wake up from neurosurgery.

  Recruiting Phase 4 Peking University First Hospital · Beijing, Beijing Municipality and 1 other locations · NCT07046364

• Diagnosing neurocognitive complications during surgery using EEG

  This study is testing if using EEG during surgery can help doctors spot early signs of cognitive problems, like delirium, in adults having non-cardiac surgeries.

  Recruiting Federal Research and Clinical Centre of Intensive Care Medicine and Rehabilitology · Moscow, Moscow Oblast · NCT06545786

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.