Effects of Volatile and Intravenous Anesthetics on Pupillary Function

August 12, 2020 updated by: Hee-Soo Kim, Seoul National University Hospital

Comparison of Effects of Volatile and Intravenous Anesthetics on Pupillary Function During General Anesthesia in Children; a Prospective Observational Study.

To compare of effects of volatile and intravenous anesthetics on pupillary function during general anesthesia in children

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The investigator will measure the pupillary function with pupillometry during general anesthesia with volatile or intravenous anesthetics in children.

Study Type

Observational

Enrollment (Anticipated)

22

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

  • Korea, Republic of
      • Seoul, Korea, Republic of, 03080
        • Recruiting
        • Seoul National University Hospital

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

3 years to 12 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

From other study results, average NPi for Sevoflurane and propofol were 3.6, 4.2, and standard deviation was 0.1, 0.4 respectively. Using Gpower program, total of 18 patients were required. Considering 20% of drop-out rate, total of 22 patients(18+3.6 patients) were to be recruited.

Description

Inclusion Criteria:

  • Pediatric patients undergoing general anesthesia

Exclusion Criteria:

  • If injection of any agents that can change pupil size or index
  • Any severe side effects, adverse drug reaction

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Sevoflurane+Remifentanil
Using inhalent agent(Sevoflurane), continuous infusion of Remifentanil
Other: sevoflurane
volatile anesthetic
Propofol+Remifentanil
Using continuous infusion of Propofol and Remifentanil
Other: propofol
intravenous anesthetic

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
NPi
Time Frame: 1hour afer skin incision
Neurological Pupil index
1hour afer skin incision

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
%CH
Time Frame: 1. Stage of loss of consciousness after induction with bolus propofol 2. Before and after tracheal intubation 3. Skin incision 4. 1hour afer skin incision 5. Just before extubation
% change of pupil size
1. Stage of loss of consciousness after induction with bolus propofol 2. Before and after tracheal intubation 3. Skin incision 4. 1hour afer skin incision 5. Just before extubation
CV
Time Frame: 1. Stage of loss of consciousness after induction with bolus propofol 2. Before and after tracheal intubation 3. Skin incision 4. 1hour afer skin incision 5. Just before extubation
Constriction Velocity
1. Stage of loss of consciousness after induction with bolus propofol 2. Before and after tracheal intubation 3. Skin incision 4. 1hour afer skin incision 5. Just before extubation
DV
Time Frame: 1. Stage of loss of consciousness after induction with bolus propofol 2. Before and after tracheal intubation 3. Skin incision 4. 1hour afer skin incision 5. Just before extubation
Dilation Velocity
1. Stage of loss of consciousness after induction with bolus propofol 2. Before and after tracheal intubation 3. Skin incision 4. 1hour afer skin incision 5. Just before extubation
NPi
Time Frame: 1. Stage of loss of consciousness after induction with bolus propofol 2. Before and after tracheal intubation 3. Skin incision 4. 1hour afer skin incision 5. Just before extubation
Neurological Pupil index
1. Stage of loss of consciousness after induction with bolus propofol 2. Before and after tracheal intubation 3. Skin incision 4. 1hour afer skin incision 5. Just before extubation

Collaborators and Investigators

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

Sponsor

Seoul National University Hospital

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)

August 12, 2020

Primary Completion (ANTICIPATED)

February 28, 2021

Study Completion (ANTICIPATED)

February 28, 2021

Study Registration Dates

First Submitted

June 13, 2019

First Submitted That Met QC Criteria

June 13, 2019

First Posted (ACTUAL)

June 17, 2019

Study Record Updates

Last Update Posted (ACTUAL)

August 17, 2020

Last Update Submitted That Met QC Criteria

August 12, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H1906-096-1040

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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