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

NCT ID: NCT02646592

Last Updated: 2017-05-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Study Completion Date

2016-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study aims to assess the Pupillary Pain Index before and after a bolus of alfentanil in children under general anesthesia, before skin incision.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pain Anesthesia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Alfentanil

Intervention Type DRUG

Bolus of alfentanil 10 µg/kg 5 minutes before skin incision

sevoflurane or propofol

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Alfentanil

Bolus of alfentanil 10 µg/kg 5 minutes before skin incision

Intervention Type DRUG

sevoflurane or propofol

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Elective surgery under general anesthesia
* Written informed consent

Exclusion Criteria

* Chronic pain
* Preoperative analgesic drug
* Neurologic disease
* Ophtalmic disease
Minimum Eligible Age

2 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Pr Isabelle CONSTANT

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Pr Isabelle CONSTANT

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Isabelle Constant, PHD

Role: STUDY_DIRECTOR

University Hospital Armand Trousseau

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Departement d'anesthesie Hopital Armand Trousseau

Paris, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

References

Explore related publications, articles, or registry entries linked to this study.

Sabourdin N, Diarra C, Wolk R, Piat V, Louvet N, Constant I. Pupillary Pain Index Changes After a Standardized Bolus of Alfentanil Under Sevoflurane Anesthesia: First Evaluation of a New Pupillometric Index to Assess the Level of Analgesia During General Anesthesia. Anesth Analg. 2019 Mar;128(3):467-474. doi: 10.1213/ANE.0000000000003681.

Reference Type DERIVED
PMID: 30198934 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

PPI Alfentanil

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.