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Pupillometry Guided Remifentanil Administration In Pediatric Anesthesia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02683837
Recruitment Status : Suspended
First Posted : February 17, 2016
Last Update Posted : April 21, 2020
Sponsor:
Information provided by (Responsible Party):
Walid HABRE, 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.

Condition or disease Intervention/treatment Phase
Anesthesia Pain Child Drug: Remifentanil Device: Pupillometry Drug: Sevoflurane Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : April 2016
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. peroperative remifentanil consumption [ Time Frame: duration of surgery ]

Secondary Outcome Measures :
  1. Morphine consumption [ Time Frame: during the 24 hour post operative period ]
  2. Incidence of morphine side effects [ Time Frame: during the 24 hour post operative period ]
    Sedation, nausea, vomiting, pruritus, urinary retention

  3. Pain scoring (verbal numerical scale) [ Time Frame: during the 24 hour post operative period ]
  4. Pain scoring (questionnaire) [ Time Frame: one month post-operatively ]


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Ages Eligible for Study:   2 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02683837


Locations
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Switzerland
Geneva Children's Hospital
Geneva, Switzerland, 1206
Sponsors and Collaborators
University Hospital, Geneva
Investigators
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Study Director: Walid Habre, MD, PhD University of Geneva
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Responsible Party: Walid HABRE, Professor, University Hospital, Geneva
ClinicalTrials.gov Identifier: NCT02683837    
Other Study ID Numbers: Pupilloped
First Posted: February 17, 2016    Key Record Dates
Last Update Posted: April 21, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Walid HABRE, University Hospital, Geneva:
Intraoperative Neurophysiological Monitoring
Reflex, Pupillary
remifentanil
Additional relevant MeSH terms:
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Remifentanil
Sevoflurane
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Platelet Aggregation Inhibitors
Anesthetics, Inhalation
Anesthetics, General
Anesthetics