Stressmonitored and regulated anaeshesia in healthy children

Autonome-nervous system regulated anaesthesia: A randomized controlled trial comparing dexmedetomedine and placebo in heart rate variability monitored children

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2022-000943-59-DK

Enrollment

250

Registered

2022-11-01

Start date

2022-12-22

Completion date

Unknown

Last updated

2024-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative agitation MedDRA version: 21.1 Level: LLT Classification code 10001499 Term: Agitation mental System Organ Class: 100000004873 MedDRA version: 21.1 Level: LLT Classification code 10056436 Term: Psychomotor agitation System Organ Class: 100000004852 MedDRA version: 20.1 Level: LLT Classification code 10079742 Term: Agitation on recovery from sedation System Organ Class: 100000004863

Interventions

Trade Name: Dexmedetomidine Product Name: Dexmedetomidine Product Code: SUB07037MIG Pharmaceutical Form: Powder for solution for injection/infusion INN or Proposed INN: Dexmedetomidine CAS Number: 113

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Children allocated for general anaesthesia in abdominal and urology setup. ASA 1-2. Consent from both parents/legal representatives Are the trial subjects under 18? yes Number of subjects for this age range: 250 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range 0 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0

Exclusion criteria

Exclusion criteria: ASA > 2, age >1 and < 6 years. Missing consent from parents/legal surrogates. Expected short-term procedures. Daily use of analgesics. Known allergies or intolerances to dexmedetomidine or remifentanil. Intubation. Furthermore, patients with parents that do not speak and write Danish fluently will be excluded too.

Design outcomes

Primary

Measure	Time frame
Main Objective: To examine if postoperative agitation can be reduced when giving optimal analgesics and dexmedetomidine while the patient is under general anaesthesia. The primary outcome measure is a Richmond agitation and sedation score. ;Secondary Objective: Not applicable;Primary end point(s): RASS score;Timepoint(s) of evaluation of this end point: Postoperative observation unit from just after awakening from anaesthesia and until leaving the hospital	—

Measure

Time frame

Main Objective: To examine if postoperative agitation can be reduced when giving optimal analgesics and dexmedetomidine while the patient is under general anaesthesia. The primary outcome measure is a Richmond agitation and sedation score. ;Secondary Objective: Not applicable;Primary end point(s): RASS score;Timepoint(s) of evaluation of this end point: Postoperative observation unit from just after awakening from anaesthesia and until leaving the hospital

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Secondary

Measure	Time frame
Secondary end point(s): Time, PONV, FLACC scale score, PAED score, nurse-NRS, parent-NRS, consumption of pain medications 24 hours postoperatively, total fentanyl dosage, total remifentanil dosage, propofol dosage. Events such as surgical stimuli, incision, cough, movement, and skin suture, in relation to ANI values. ;Timepoint(s) of evaluation of this end point: In the postoperative awakening phase and as a questionnaire/phone interview 24 hours after anaesthesia	—

Measure

Time frame

Secondary end point(s): Time, PONV, FLACC scale score, PAED score, nurse-NRS, parent-NRS, consumption of pain medications 24 hours postoperatively, total fentanyl dosage, total remifentanil dosage, propofol dosage. Events such as surgical stimuli, incision, cough, movement, and skin suture, in relation to ANI values. ;Timepoint(s) of evaluation of this end point: In the postoperative awakening phase and as a questionnaire/phone interview 24 hours after anaesthesia

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Countries

Denmark

Contacts

Public ContactOpen Patient Data Explorative netw

Odense University Hospital

open@rsyd.dk004529166730

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026