CClinicalTrials.gg
Status unknownNCT03987529Updated Aug 17, 2020

Effects of Volatile and Intravenous Anesthetics on Pupillary Function

An observational study in Pupillary Functions, Abnormal, sponsored by Seoul National University Hospital. Status unknown at 1 site in Korea, Republic of. Open to participants aged 3 Years to 12 Years. Per ClinicalTrials.gov, last updated 2020-08-17.

Sponsored by Seoul National University Hospital · Observational

The sponsor has not verified this record recently (last verified Aug 2020), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
22
Ages
3 Years to 12 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Pupillary Functions, Abnormal
03

In context

Lead sponsor

Seoul National University Hospital is the lead sponsor of 1,860 studies on the registry; 275 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
3 Years to 12 Years
Sexes eligible
All
Accepts healthy volunteers
No
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.

Inclusion criteria

  • Pediatric patients undergoing general anesthesia

Exclusion criteria

Exclusion Criteria:

  • If injection of any agents that can change pupil size or index
  • Any severe side effects, adverse drug reaction
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
22 participants (estimated)
Patient registry
No

Groups and cohorts

  • Sevoflurane+Remifentanil

    Using inhalent agent(Sevoflurane), continuous infusion of Remifentanil

    Other: sevoflurane

  • Propofol+Remifentanil

    Using continuous infusion of Propofol and Remifentanil

    Other: propofol

Interventions

  • Othersevoflurane

    volatile anesthetic

  • Otherpropofol

    intravenous anesthetic

06

What researchers measure

Primary outcomes

  1. NPi

    Neurological Pupil index

    Time frame: 1hour afer skin incision

Secondary outcomes

  1. %CH

    % change of pupil size

    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

  2. CV

    Constriction Velocity

    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

  3. DV

    Dilation Velocity

    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

  4. NPi

    Neurological Pupil index

    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

07

Study locations

1 of 1 sites recruiting
  • Seoul National University Hospital
    Seoul, 03080, Korea, Republic of
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 17, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03987529
Lead sponsor
Seoul National University Hospital
Responsible party
Hee-Soo Kim (professor, Seoul National University Hospital) — Principal investigator
First posted
Jun 17, 2019
Start date
Aug 12, 2020
Primary completion
Feb 28, 2021 (estimated)
Completion
Feb 28, 2021 (estimated)
Last update
Aug 17, 2020

Study contacts

Sang-Hwan Ji, M.D., M.S.
Contact
taepoongshin@gmail.com
+82-2-2072-3661
Hee-Soo Kim, M.D., Ph.D.
principal investigator · Seoul National University Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.

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