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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON38989

Enrollment

Registered

2013-07-10

Start date

2013-07-01

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 Narcotrend* with a Narcotrend Index (NI) target range of 65±

Eligibility

Age

12 Years to 17 Years

Inclusion criteria

Inclusion criteria: • Written informed consent of patients and their parents/legal representatives • Age >=12

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 • 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

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) • Assessment of endoscopy conditions (by paediatric gastroenterologist) • Adverse events • Economic Analysis (Cost minimization analysis, CMA)	—

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) • Assessment of endoscopy conditions (by paediatric gastroenterologist) • Adverse events • Economic Analysis (Cost minimization analysis, CMA)

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)