Stressmonitored and regulated anaeshesia in healthy childre

Phase 1

• Conditions: Postoperative agitation; MedDRA version: 21.1Level: LLTClassification code 10001499Term: Agitation mentalSystem Organ Class: 100000004873; MedDRA version: 22.1Level: LLTClassification code 10001498Term: Agitation aggravatedSystem Organ Class: 100000004873; MedDRA version: 21.1Level: LLTClassification code 10021651Term: Increased agitationSystem Organ Class: 100000004873; MedDRA version: 21.1Level: LLTClassification code 10056436Term: Psychomotor agitationSystem Organ Class: 100000004852; MedDRA version: 20.1Level: LLTClassification code 10079742Term: Agitation on recovery from sedationSystem Organ Class: 200000008294; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2022-000943-59-DK
• Lead Sponsor: Odense University Hospital, anaeshtesiologic intensive ward V

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-11-01
• Last Update Posted: 9 January 2023

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 250

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
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