Effects of Volatile and Intravenous Anesthetics on Pupillary Function
Comparison of Effects of Volatile and Intravenous Anesthetics on Pupillary Function During General Anesthesia in Children; a Prospective Observational Study.
1 other identifier
observational
22
1 country
1
Brief Summary
To compare of effects of volatile and intravenous anesthetics on pupillary function during general anesthesia in children
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Aug 2020
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 13, 2019
CompletedFirst Posted
Study publicly available on registry
June 17, 2019
CompletedStudy Start
First participant enrolled
August 12, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2021
CompletedAugust 17, 2020
August 1, 2020
7 months
June 13, 2019
August 12, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
NPi
Neurological Pupil index
1hour afer skin incision
Secondary Outcomes (4)
%CH
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
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
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
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
Study Arms (2)
Sevoflurane+Remifentanil
Using inhalent agent(Sevoflurane), continuous infusion of Remifentanil
Propofol+Remifentanil
Using continuous infusion of Propofol and Remifentanil
Interventions
Eligibility Criteria
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.
You may qualify if:
- Pediatric patients undergoing general anesthesia
You may not qualify if:
- If injection of any agents that can change pupil size or index
- Any severe side effects, adverse drug reaction
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seoul National University Hospital
Seoul, 03080, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hee-Soo Kim, M.D., Ph.D.
Seoul National University Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- professor
Study Record Dates
First Submitted
June 13, 2019
First Posted
June 17, 2019
Study Start
August 12, 2020
Primary Completion
February 28, 2021
Study Completion
February 28, 2021
Last Updated
August 17, 2020
Record last verified: 2020-08
Data Sharing
- IPD Sharing
- Will not share