Pupillometry Guided Remifentanil Administration In Pediatric Anesthesia

Not Applicable

Withdrawn

• Conditions: Pain; Anesthesia; Child
• Interventions: Drug: Remifentanil; Device: Pupillometry; Drug: Sevoflurane

• Registration Number: NCT02683837
• Lead Sponsor: University Hospital, Geneva

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-01-19
• Study First Submitted QC: 2016-02-11
• Study First Posted: 2016-02-17
• Study Start: 2016-04
• Primary Completion: 2016-11
• Study Completion: 2022-12
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-16
• Last Update Posted: 2024-04-18

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pupillometry	Pupillometry	Remifentanil infusion guided by changes in pupillary diameter. Anesthesia maintenance with sevoflurane.
Standard practice	Remifentanil	Remifentanil infusion guided by usual clinical signs (heart rate, blood pressure). Pupillometry blindly recorded. Anesthesia maintenance with sevoflurane.
Standard practice	Sevoflurane	Remifentanil infusion guided by usual clinical signs (heart rate, blood pressure). Pupillometry blindly recorded. Anesthesia maintenance with sevoflurane.
Pupillometry	Remifentanil	Remifentanil infusion guided by changes in pupillary diameter. Anesthesia maintenance with sevoflurane.
Pupillometry	Sevoflurane	Remifentanil infusion guided by changes in pupillary diameter. Anesthesia maintenance with sevoflurane.

Primary Outcome Measures

Name	Time	Method
peroperative remifentanil consumption	duration of surgery

Secondary Outcome Measures

Name	Time	Method
Pain scoring (questionnaire)	one month post-operatively
Pain scoring (verbal numerical scale)	during the 24 hour post operative period
Incidence of morphine side effects	during the 24 hour post operative period	Sedation, nausea, vomiting, pruritus, urinary retention
Morphine consumption	during the 24 hour post operative period

Trial Locations

Locations (1)

Geneva Children's Hospital; 🇨🇭 Geneva, Switzerland