The influence of electroencephalographic Narcotrend IndexTM- guidance of propofol administration on recovery from procedural sedation for gastrointestinal endoscopy in children between 1 and 12 years

The influence of electroencephalographic Narcotrend IndexTM- guidance of propofol administration on recovery from procedural sedation for gastrointestinal endoscopy in children between 1 and 12 years - NI-PPS 2

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON43430

Enrollment

Registered

2016-02-15

Start date

2016-04-04

Completion date

Unknown

Last updated

2024-06-11

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

Conditions

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

Interventions

In patients in the intervention group the anaesthetic propofol will be titrated according to depth of hypnosis (DoH) data provided by the NarcotrendTM with a Narcotrend Index (NI) target range of 70

Eligibility

Age

2 Years to 11 Years

Inclusion criteria

Inclusion criteria: • Written informed consent of parents/legal representatives • Age >=1 5 and

Exclusion criteria

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 • Parents/legal guardians 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

Design outcomes

Primary

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

Secondary

Measure	Time frame
Secondary Objective(s): • Cumulative propofol consumption • Total time from discontinuation of propofol delivery until discharge from the post anaesthesia care unit • Posthoc intergroup comparison of hypnotic depth as measured by Narcotrend • Detection of possible recall of events during the procedure (awareness), in children older than 6 years • Assessment of endoscopy conditions (by paediatric gastroenterologist) • Adverse events	—

Measure

Time frame

Secondary Objective(s): • Cumulative propofol consumption • Total time from discontinuation of propofol delivery until discharge from the post anaesthesia care unit • Posthoc intergroup comparison of hypnotic depth as measured by Narcotrend • Detection of possible recall of events during the procedure (awareness), in children older than 6 years • Assessment of endoscopy conditions (by paediatric gastroenterologist) • Adverse events

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)