Pupillometry Guided Remifentanil Administration In Pediatric Anesthesia

Pain Clinical Trial

Official title:

A Prospective Randomized Study Evaluating Pupillometry Guided Remifentanil Administration in Pediatric Anesthesia

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02683837
• Other study ID #: Pupilloped
• Status: Withdrawn
• Phase: N/A
• Start date: April 2016
• Est. completion date: December 2022

Study information

• Verified date: April 2024
• Source: University Hospital, Geneva
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2022
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia
• Child
• Pain

Intervention

Drug:
• Remifentanil

Device:
• Pupillometry
Pupillary diameter measured every 5 minutes

Drug:
• Sevoflurane
Administered to maintain a Bispectral Index between 40 and 60

Locations

Country	Name	City	State
Switzerland	Geneva Children's Hospital	Geneva

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Geneva

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	peroperative remifentanil consumption		duration of surgery
Secondary	Morphine consumption		during the 24 hour post operative period
Secondary	Incidence of morphine side effects	Sedation, nausea, vomiting, pruritus, urinary retention	during the 24 hour post operative period
Secondary	Pain scoring (verbal numerical scale)		during the 24 hour post operative period
Secondary	Pain scoring (questionnaire)		one month post-operatively