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Comparison of Effects of Volatile and Intravenous Anesthetics on Pupillary Function in Children

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. Identifier: NCT03987529
Recruitment Status : Not yet recruiting
First Posted : June 17, 2019
Last Update Posted : June 19, 2019
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 Phase
Pupillary Functions, Abnormal Other: sevoflurane Other: desflurane Other: propofol Not Applicable

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Comparison of Effects of Volatile and Intravenous Anesthetics on Pupillary Function During General Anesthesia in Children; a Prospective, Observational, Randomized Controlled Trial.
Estimated Study Start Date : September 11, 2019
Estimated Primary Completion Date : September 11, 2020
Estimated Study Completion Date : October 11, 2020

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

Experimental: Desflurane+Remifentanil
Using inhalent agent(Desflurane), continuous infusion of Remifentanil
Other: desflurane
volatile anesthetic

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

Primary Outcome Measures :
  1. pupillary function [ Time Frame: 1 hour after surgery started ]
    neurologic pupil index

Secondary Outcome Measures :
  1. %CH [ Time Frame: 1 hour after surgery, end of surgery ]
    % change of pupil size

  2. CV [ Time Frame: 1 hour after surgery, end of surgery ]
    Constriction Velocity

  3. DV [ Time Frame: 1 hour after surgery, end of surgery ]
    Dilation Velocity

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Pediatric patients undergoind 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 Identifier: NCT03987529     History of Changes
Other Study ID Numbers: 2019-2284
First Posted: June 17, 2019    Key Record Dates
Last Update Posted: June 19, 2019
Last Verified: June 2019
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
Anesthetics, Intravenous
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, General
Analgesics, Opioid
Sensory System Agents
Peripheral Nervous System Agents
Platelet Aggregation Inhibitors
Anesthetics, Inhalation