The influence of electroencephalographic Narcotrend Index*- guidance of propofol administration on recovery from procedural sedation for gastrointestinal endoscopy in paediatric patients

Conditions: onderzoek tijdens procedurele sedatie bij kinderen, niet gerelateerd aan specifieke aandoeningen
not applicable

Registration Number: NL-OMON38989

Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 40

Inclusion Criteria

• Written informed consent of patients and their parents/legal representatives
• Age >=12 <17 years
• Bodyweight <= 60 kg
• Gastrointestinal endoscopy
• Eligibility for procedural sedation
• Ability of the patient to communicate in Dutch

Exclusion Criteria

Primary exclusion criteria
• Withdrawal of informed consent
• Chronic exposure (more than one day) to psychotropic drugs and/or opioids
• Known allergy/intolerance for propofol and/or remifentanil
• Anticipated difficult airway
• Child not eligible for procedural sedation, need for inhalation induction and general anaesthesia
• Patient and/or parents unable to communicate in Dutch;Secondary exclusion criteria
• Unexpected need for inhalation induction of general anaesthesia due to major difficulties to obtain intravenous access.
• Unexpected procedural events requiring endotracheal intubation

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary objective of this study is the effect of NI monitoring on the speed<br /><br>of recovery from procedural sedation for paediatric gastrointestinal endoscopy.<br /><br>Speed of recovery is defined as the time interval between the end of propofol<br /><br>application and the moment when discharge criteria from the operating room are<br /><br>met.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary Objective(s):<br /><br>• Cumulative propofol consumption<br /><br>• Total time from discontinuation of propofol delivery until discharge from the<br /><br>post anaesthesia care unit<br /><br>• Posthoc intergroup comparison of hypnotic depth as measured by Narcotrend<br /><br>• Detection of possible recall of events during the procedure (awareness)<br /><br>• Assessment of endoscopy conditions (by paediatric gastroenterologist)<br /><br>• Adverse events<br /><br>• Economic Analysis (Cost minimization analysis, CMA)</p><br>