Newborn Infant Parasympathetic Evaluation (NIPE) Index After Standardized Tetanic Stimulations Under General Anesthesia (NIPESTIM)

University Hospital, Lille

Status: Completed

Conditions: Anesthesia

Treatments: Procedure: Tetanic stimulations; Device: NIPE monitor

Study type: Interventional

Funder types: Other

Identifiers

NCT04381637

2020-A00295-34 (Other Identifier)

2019_32

Details and patient eligibility

About

NIPE monitor is the recently developed pediatric version of the ANI monitor, which is used in adults to monitor analgesia during general anesthesia. In adults, under general anesthesia, ANI decreases after a nociceptive stimulation. The amplitude of this decrease is related to the intensity of the stim. This study aims to investigate if NIPE index decreases in the same manner after stimulations in anesthetized children.

Enrollment: 34 patients

Sex: All

Ages: 6 to 10 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Elective surgery under general anesthesia requiring tracheal intubation and muscle relaxation
• Written informed consent obtained from parents (and from child if appropriate)

Exclusion criteria

• Thoracic or cardiac surgery
• Cardiac arrhythmia, Pace maker
• Analgesic medication less than 24 hours before surgery
• Chronic anticholinergic medication
• Contraindication to muscle relaxants or general anesthetics

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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34 participants in 1 patient group

NIPE

Experimental group

Treatment:

Procedure: Tetanic stimulations

Device: NIPE monitor