Pupillometry Guided Remifentanil Administration In Pediatric Anesthesia

• Sponsor: University Hospital, Geneva (Other)
• Overall Status: Suspended
• CT.gov ID: NCT02683837
• Collaborator: (none)
• Enrollment: 56
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 80
• Patients Per Site Per Month: 0.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Anesthesia; Pain; Child	Drug: Remifentanil; Device: Pupillometry; Drug: Sevoflurane	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 56 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: A Prospective Randomized Study Evaluating Pupillometry Guided Remifentanil Administration in Pediatric Anesthesia
• Actual Study Start Date: Apr 1, 2016
• Actual Primary Completion Date: Nov 1, 2016
• Anticipated Study Completion Date: Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Standard practice Remifentanil infusion guided by usual clinical signs (heart rate, blood pressure). Pupillometry blindly recorded. Anesthesia maintenance with sevoflurane.	Drug: Remifentanil; Drug: Sevoflurane; Administered to maintain a Bispectral Index between 40 and 60
Experimental: Pupillometry Remifentanil infusion guided by changes in pupillary diameter. Anesthesia maintenance with sevoflurane.	Drug: Remifentanil; Device: Pupillometry; Pupillary diameter measured every 5 minutes; Drug: Sevoflurane; Administered to maintain a Bispectral Index between 40 and 60

Outcome Measures

Primary Outcome Measures

1. peroperative remifentanil consumption [duration of surgery]

Secondary Outcome Measures

1. Morphine consumption [during the 24 hour post operative period]

2. Incidence of morphine side effects [during the 24 hour post operative period]

   Sedation, nausea, vomiting, pruritus, urinary retention

3. Pain scoring (verbal numerical scale) [during the 24 hour post operative period]

4. Pain scoring (questionnaire) [one month post-operatively]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 2 Years to 16 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Geneva Children's Hospital	Geneva		Switzerland	1206

Sponsors and Collaborators

• University Hospital, Geneva

Investigators

• Study Director: Walid Habre, MD, PhD, University of Geneva

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Walid HABRE, Professor, University Hospital, Geneva
• ClinicalTrials.gov Identifier: NCT02683837
• Other Study ID Numbers: Pupilloped
• First Posted: Feb 17, 2016
• Last Update Posted: Jul 21, 2021
• Last Verified: Jul 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Walid HABRE, Professor, University Hospital, Geneva: Intraoperative Neurophysiological Monitoring; Reflex, Pupillary; remifentanil
• Additional relevant MeSH terms: Remifentanil; Sevoflurane

Study Results

No Results Posted as of Jul 21, 2021