Pupillometry Guided Remifentanil Administration In Pediatric Anesthesia

NCT02683837 | Withdrawn

• 1 other identifier: Pupilloped
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anesthesia; Pain; Child

Keywords

Intraoperative Neurophysiological Monitoring; Reflex, Pupillary; remifentanil

Outcome Measures

Primary Outcomes (1)

• peroperative remifentanil consumption

  duration of surgery

Secondary Outcomes (4)

• Morphine consumption

  during the 24 hour post operative period

• Incidence of morphine side effects

  during the 24 hour post operative period

• Pain scoring (verbal numerical scale)

  during the 24 hour post operative period

• Pain scoring (questionnaire)

  one month post-operatively

Study Arms (2)

Standard practice

ACTIVE COMPARATOR

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

Drug: Remifentanil; Drug: Sevoflurane

Pupillometry

EXPERIMENTAL

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

Drug: Remifentanil; Device: Pupillometry; Drug: Sevoflurane

Interventions

Remifentanil DRUG

Pupillometry; Standard practice

Pupillometry DEVICE

Pupillary diameter measured every 5 minutes

Pupillometry

Sevoflurane DRUG

Administered to maintain a Bispectral Index between 40 and 60

Pupillometry; Standard practice

Eligibility Criteria

• Age: 2 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Geneva: lead

Study Sites (1)

Geneva Children's Hospital

Geneva, 1206, Switzerland

Location

MeSH Terms

Conditions

Pain

Interventions

Remifentanil; Sevoflurane

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Methyl Ethers; Ethers; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons

Study Officials

• Walid Habre, MD, PhD

  University of Geneva

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 19, 2016
• First Posted: February 17, 2016
• Study Start: April 1, 2016
• Primary Completion: November 1, 2016
• Study Completion: December 1, 2022
• Last Updated: April 18, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)