Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effects of Volatile and Intravenous Anesthetics on Pupillary Function

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03987529
Recruitment Status : Not yet recruiting
First Posted : June 17, 2019
Last Update Posted : April 14, 2020
Sponsor:
Information provided by (Responsible Party):
Hee-Soo Kim, Seoul National University Hospital

Tracking Information
First Submitted Date June 13, 2019
First Posted Date June 17, 2019
Last Update Posted Date April 14, 2020
Estimated Study Start Date April 16, 2020
Estimated Primary Completion Date September 11, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 29, 2019)
NPi [ Time Frame: 1hour afer skin incision ]
Neurological Pupil index
Original Primary Outcome Measures
 (submitted: June 13, 2019)
pupillary function [ Time Frame: 1 hour after surgery started ]
neurologic pupil index
Change History
Current Secondary Outcome Measures
 (submitted: December 29, 2019)
  • %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
  • 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
  • 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
  • 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
Original Secondary Outcome Measures
 (submitted: June 13, 2019)
  • %CH [ Time Frame: 1 hour after surgery, end of surgery ]
    % change of pupil size
  • CV [ Time Frame: 1 hour after surgery, end of surgery ]
    Constriction Velocity
  • DV [ Time Frame: 1 hour after surgery, end of surgery ]
    Dilation Velocity
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Effects of Volatile and Intravenous Anesthetics on Pupillary Function
Official Title Comparison of Effects of Volatile and Intravenous Anesthetics on Pupillary Function During General Anesthesia in Children; a Prospective Observational Study.
Brief Summary 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 Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Pupillary Functions, Abnormal
Intervention
  • Other: sevoflurane
    volatile anesthetic
  • Other: propofol
    intravenous anesthetic
Study Groups/Cohorts
  • Sevoflurane+Remifentanil
    Using inhalent agent(Sevoflurane), continuous infusion of Remifentanil
    Intervention: Other: sevoflurane
  • Propofol+Remifentanil
    Using continuous infusion of Propofol and Remifentanil
    Intervention: Other: propofol
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: December 29, 2019)
22
Original Estimated Enrollment
 (submitted: June 13, 2019)
66
Estimated Study Completion Date October 11, 2020
Estimated Primary Completion Date September 11, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 3 Years to 12 Years   (Child)
Accepts Healthy Volunteers No
Contacts
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT03987529
Other Study ID Numbers H1906-096-1040
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Hee-Soo Kim, Seoul National University Hospital
Study Sponsor Seoul National University Hospital
Collaborators Not Provided
Investigators Not Provided
PRS Account Seoul National University Hospital
Verification Date April 2020