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Effects of Volatile and Intravenous Anesthetics on Pupillary Function

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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

Brief Summary:
To compare of effects of volatile and intravenous anesthetics on pupillary function during general anesthesia in children

Condition or disease Intervention/treatment
Pupillary Functions, Abnormal Other: sevoflurane Other: propofol

Detailed Description:
The investigator will measure the pupillary function with pupillometry during general anesthesia with volatile or intravenous anesthetics in children.

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Study Type : Observational
Estimated Enrollment : 22 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Comparison of Effects of Volatile and Intravenous Anesthetics on Pupillary Function During General Anesthesia in Children; a Prospective Observational Study.
Estimated Study Start Date : April 16, 2020
Estimated Primary Completion Date : September 11, 2020
Estimated Study Completion Date : October 11, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Sevoflurane+Remifentanil
Using inhalent agent(Sevoflurane), continuous infusion of Remifentanil
Other: sevoflurane
volatile anesthetic

Propofol+Remifentanil
Using continuous infusion of Propofol and Remifentanil
Other: propofol
intravenous anesthetic




Primary Outcome Measures :
  1. NPi [ Time Frame: 1hour afer skin incision ]
    Neurological Pupil index


Secondary Outcome Measures :
  1. %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

  2. 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

  3. 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

  4. 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



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Ages Eligible for Study:   3 Years to 12 Years   (Child)
Sexes Eligible for Study:   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.
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
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Responsible Party: Hee-Soo Kim, professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT03987529    
Other Study ID Numbers: H1906-096-1040
First Posted: June 17, 2019    Key Record Dates
Last Update Posted: April 14, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pupil Disorders
Neurologic Manifestations
Nervous System Diseases
Eye Diseases
Signs and Symptoms
Propofol
Sevoflurane
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Platelet Aggregation Inhibitors
Anesthetics, Inhalation