Pupillometry Guided Remifentanil Administration In Pediatric Anesthesia

University Hospitals (UH)

Status: Withdrawn

Conditions: Child; Pain; Anesthesia

Treatments: Drug: Remifentanil; Drug: Sevoflurane; Device: Pupillometry

Study type: Interventional

Funder types: Other

Identifiers

NCT02683837

Pupilloped

Details and patient eligibility

About

The aim of this prospective randomized study is to evaluate the impact of peroperative pupillometry monitoring on per and post-operative opioid consumption in pediatric anesthesia. All patients are anesthetized with sevoflurane and remifentanil. In the intervention group, peroperative remifentanil infusion rate is guided by pupillometry. In the other group, remifentanil infusion rate is guided according to hemodynamic data.

Sex: All

Ages: 2 to 16 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Children scheduled for a surgery lasting more than 90 minutes.

Exclusion criteria

• Contraindication to sevoflurane, to remifentanil or to morphine.
• Peripheral or central nerve block during and after surgery.
• Ophthalmological disease.
• Peroperative position with no acess to the head.
• Chronic use of medication interfering with pupillary diameter.
• Ambulatory surgery

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 2 patient groups

Standard practice

Active Comparator group

Description:

Remifentanil infusion guided by usual clinical signs (heart rate, blood pressure). Pupillometry blindly recorded. Anesthesia maintenance with sevoflurane.

Treatment:

Drug: Sevoflurane

Drug: Remifentanil

Pupillometry

Experimental group

Description:

Remifentanil infusion guided by changes in pupillary diameter. Anesthesia maintenance with sevoflurane.

Treatment:

Drug: Sevoflurane

Device: Pupillometry

Drug: Remifentanil