Effect of a Bolus of 10 µg/kg of Alfentanil on the Pupillary Pain Index

May 2, 2017 updated by: Pr Isabelle CONSTANT
This study aims to assess the Pupillary Pain Index before and after a bolus of alfentanil in children under general anesthesia, before skin incision.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75012
        • Departement d'anesthesie Hopital Armand Trousseau

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Elective surgery under general anesthesia
  • Written informed consent

Exclusion Criteria:

  • Chronic pain
  • Preoperative analgesic drug
  • Neurologic disease
  • Ophtalmic disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: alfentanil

Children under general anesthesia for elective surgery. Induction with sevoflurane or propofol according to the preference of the patient.

Maintenance with sevoflurane. 5 minutes before skin incision, first assessment of the pupillary pain index. Then injection of 10 µg/kg of alfentanil. After 5 minutes second assessment of pupillary pain index. End of study period, beginning of surgery.
Drug: Alfentanil
Bolus of alfentanil 10 µg/kg 5 minutes before skin incision
Drug: sevoflurane or propofol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change between Pupillary Pain Index before and after alfentanil bolus
Time Frame: Five minutes before incision and just before incision. Each measure = 20 seconds
pupillometry
Five minutes before incision and just before incision. Each measure = 20 seconds

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pr Isabelle CONSTANT

Investigators

  • Study Director: Isabelle Constant, PHD, University Hospital Armand Trousseau

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2016

Primary Completion (Actual)

October 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

January 4, 2016

First Submitted That Met QC Criteria

January 4, 2016

First Posted (Estimate)

January 5, 2016

Study Record Updates

Last Update Posted (Actual)

May 3, 2017

Last Update Submitted That Met QC Criteria

May 2, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PPI Alfentanil

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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