To evaluate the impact of electroencephalographic Narcotrend* Index (NI) monitoring on the speed of emergence and recovery from PPS for PGE.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
onderzoek tijdens procedurele sedatie bij kinderen, niet gerelateerd aan specifieke aandoeningen
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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)
Background summary
EEG-based depth of hypnosis (DoH) monitoring during paediatric procedural
sedation (PPS) may result in a faster recovery after the procedure, compared to
a standard PPS regimen. From a scientific point of view the key question is
whether the application of DoH monitoring results in advantages for both the
patient (probably less exposure to propofol and faster recovery) and the health
care providers (enhanced workflow on the operation room) are big enough to
spend some extra money for the DoH-monitoring devices and disposables. This
question will be approached in a series of three clinical trials. Part one of
the whole project is this trial especially designed for the setting of PPS
during paediatric gastrointestinal endoscopy (PGE).
Study objective
To evaluate the impact of electroencephalographic Narcotrend* Index (NI)
monitoring on the speed of emergence and recovery from PPS for PGE.
Study design
Single centre, prospective randomised, double-blind, controlled trial.
Intervention
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±5. In patients in the control group,
the conduct of PPS is based on commonly applied conventional clinical surrogate
parameters of DoH, such as heart rate, blood pressure and patient movement.
Study burden and risks
In patients in the intervention group PPS will be administered on the basis of
objective measures of anaesthetic depth, the NI values. We expect a
significantly faster emergence than with the conventional PPS approach. The
Narcotrend has been validated for use in paediatric patients. There are thus no
additional risk factors apart from those, which are inherent with
gastrointestinal endoscopy under procedural sedation. A non-invasive
therapeutical intervention (NI-based conduct of PPS) should result in the
advantage of faster recovery, without any additional risk factor.
Patients in the control group will receive standard treatment, that is delivery
of propofol based on the judgement of clinical surrogate parameters of DoH.
Dr. Molewaterplein 60
Rotterdam 3015GJ
NL
Dr. Molewaterplein 60
Rotterdam 3015GJ
NL
Listed location countries
Age
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
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2013-02122-23-NL |
| CCMO | NL44307.078.13 |
| OMON | NL-OMON28327 |