- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03987529
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
-
-
-
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
|
volatile anesthetic
|
Propofol+Remifentanil
Using continuous infusion of Propofol and Remifentanil
|
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.
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
- Nervous System Diseases
- Eye Diseases
- Neurologic Manifestations
- Pupil Disorders
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Anesthetics, Intravenous
- Anesthetics, General
- Anesthetics
- Platelet Aggregation Inhibitors
- Hypnotics and Sedatives
- Anesthetics, Inhalation
- Propofol
- Sevoflurane
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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