Investigation of Pupillometry as Guide for Extubation Readiness in Anesthetized Children

NCT ID: NCT04947397

Last Updated: 2025-01-22

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-20

Study Completion Date

2023-02-01

Brief Summary

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Investigation of pupillometry as guide for extubation readiness in anesthetized children.

Detailed Description

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Can a pupil metric be used to make extubation more safe in anesthetized children?

Conditions

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Anesthesia Laryngospasm on Emergence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Group 1

Traditional deep extubation at 1.5 minimum alveolar concentration (MAC)

Group Type NO_INTERVENTION

No interventions assigned to this group

Group 2

Deep extubation guided by pupillometry -- at \< 0.5 MAC of vapor + propofol and fentanyl

Group Type EXPERIMENTAL

Pupillometry

Intervention Type DIAGNOSTIC_TEST

Pupillometry prior to extubation

Interventions

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Pupillometry

Pupillometry prior to extubation

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Children undergoing general anesthesia and endotracheal intubation for surgery.
* American Society of Anesthesiologists Physical Status Class I and II patients.

Exclusion Criteria

* Central nervous system abnormality.
* Ophthalmologic abnormality.
Minimum Eligible Age

2 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of California, San Francisco

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Daniel Abelson, MD

Role: PRINCIPAL_INVESTIGATOR

UCSF Benioff Children's Hospital Oakland

Locations

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UCSF Benioff Children's Hospital Oakland

Oakland, California, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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20-32664

Identifier Type: -

Identifier Source: org_study_id

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