Pupillary Functions, AbnormalNCT03987529
Effects of Volatile and Intravenous Anesthetics on Pupillary Function
An observational study of Pupillary Functions, Abnormal, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
To compare of effects of volatile and intravenous anesthetics on pupillary function during general anesthesia in children Read more about this study
- Who is it for?
- Ages 3 to 12 years
- Conditions the study is for
- Pupillary Functions, Abnormal
- What is being tested?
- sevoflurane and propofol
- Type of treatment
- Injection or infusion
- How many people
- 22 participants
- Where
- 1 siteSouth Korea
- Study dates
- 12 Aug 2020to 28 Feb 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 12 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- Pediatric patients undergoing general anesthesia
Who cannot join
- If injection of any agents that can change pupil size or index
- Any severe side effects, adverse drug reaction
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul, 03080
Hee-Soo Kim, PhD, +82220723659, dami0605@snu.ac.kr
About this study
Official title: 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
Read the detailed description
The investigator will measure the pupillary function with pupillometry during general anesthesia with volatile or intravenous anesthetics in children.
- Conditions
- Pupillary Functions, Abnormal
- Being tested
- sevoflurane, propofol
- Medical subject headings
- Pupil Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sevofluraneOther
volatile anesthetic
propofolOther
intravenous anesthetic
| Study group | Role | What they receive |
|---|---|---|
| Sevoflurane+Remifentanil | Using inhalent agent(Sevoflurane), continuous infusion of Remifentanil Receives: Other: sevoflurane | |
| Propofol+Remifentanil | Using continuous infusion of Propofol and Remifentanil Receives: Other: propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
NPi
Neurological Pupil index
Measured: 1hour afer skin incision
Secondary outcomes (4)
%CH
% change of pupil size
Measured: 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
Constriction Velocity
Measured: 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
Dilation Velocity
Measured: 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
Neurological Pupil index
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2019
- Study start12 Aug 2020
- Primary completion28 Feb 2021 (estimated)
- Study completion28 Feb 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pupillary Functions, AbnormalStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hee-Soo Kim, Seoul National University Hospital
- Investigators
- Hee-Soo Kim, M.D., Ph.D., Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03987529
- Sponsor's protocol ID
- H1906-096-1040
- Status last verified
- Aug 2020
- First submitted
- 13 Jun 2019
- Last updated
- 17 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Effects of Volatile and Intravenous Anesthetics on Pupillary Function During General Anesthesia in Children; a Prospective Observational Study.
- ClinicalTrials.gov ID
- NCT03987529
- Acronym / sponsor ID
- H1906-096-1040
- Conditions
- Pupillary Functions, Abnormal
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 12 Aug 2020 (actual)
- Primary completion
- 28 Feb 2021 (estimated)
- Study completion
- 28 Feb 2021 (estimated)
- First posted
- 17 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To compare of effects of volatile and intravenous anesthetics on pupillary function during general anesthesia in children
Detailed description
The investigator will measure the pupillary function with pupillometry during general anesthesia with volatile or intravenous anesthetics in children.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sevoflurane+Remifentanil | – | Other: sevofluraneUsing inhalent agent(Sevoflurane), continuous infusion of Remifentanil |
| Propofol+Remifentanil | – | Other: propofolUsing continuous infusion of Propofol and Remifentanil |
Who may qualify
- Ages
- 3 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (1 listed)
- Pediatric patients undergoing general anesthesia
Key exclusion criteria (2 listed)
- If injection of any agents that can change pupil size or index
- Any severe side effects, adverse drug reaction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sevofluranevolatile anesthetic | Other | Sevoflurane+Remifentanil |
| propofolintravenous anesthetic | Other | Propofol+Remifentanil |
Primary outcome
NPi
Time frame: 1hour afer skin incision
Neurological Pupil index
4 secondary outcomes
%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
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
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2020.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hee-Soo Kim, M.D., Ph.D. principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pupillary Functions, Abnormal, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sang-Hwan Ji, M.D., M.S. (+82-2-2072-3661, taepoongshin@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NPi (time frame: 1hour afer skin incision). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2020.