Phase 3 study

Recruiting Phase 3

Sources: ClinicalTrials.gov Checked: 11 October 2026 Not medical advice

This trial at a glance

Status Recruiting
Phase Phase 3
Sponsor Copenhagen University Hospital, Rigshospitalet
Registry number NCT05091242
Started 25 October 2021 Today 16 October 2026 Estimated completion 31 January 2028

Where this trial is running

Trial sites and the status recorded for each
SiteCityState or countryStatus at this site
Perth Children's Hospital, Department of Anaesthesia and Pain Medicine Perth WA Recruiting

voxsanity.com.au · trial sites from public registries · registry record synced 11 October 2026 · not medical advice

Who can join

Age 3 Months to 12 Months
Sex Anyone, regardless of sex
Healthy volunteers Not accepted
Enrolment target 336

The official eligibility criteria

Registry text, reproduced exactly. These are the words the trial's sponsor published on ClinicalTrials.gov. They have not been edited, shortened or rewritten, and they are written for researchers rather than for patients.

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)

Dates on the record

Started 25 October 2021
Estimated completion 31 January 2028
Registry last updated 12 August 2026
Checked by Voxsanity 11 October 2026

Results, publications and the official record

Sources and dates

  • ClinicalTrials.gov – the record this page reformats
  • ClinicalTrials.gov processing date: 12 August 2026.
  • This page last checked by Voxsanity: 11 October 2026.

Voxsanity reformats data from public registries into this layout. It does not edit, interpret or add to what the registry published.

Not medical advice.

Individual trial records are refreshed on a rolling basis rather than all at once, so a record may be up to several weeks old. Each trial page and trial card shows the date its own record was last synced. Where a record has lagged, its status, sites and enrolment can differ from the current registry state in either direction, so check the registry link on the trial page before acting on them.

Letter for your doctor

A one-page summary of this trial to print or email to your GP. It carries the registry's own record of the trial and its eligibility criteria, and nothing Voxsanity has written about whether it suits you.