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Pupillometry-guided Remifentanil Infusion Versus Conventional Administration in Children (PURFT)

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: NCT03749811
Recruitment Status : Recruiting
First Posted : November 21, 2018
Last Update Posted : March 29, 2019
Sponsor:
Information provided by (Responsible Party):
Hee-Soo Kim, Seoul National University Hospital

Brief Summary:
Our study aims to compare the total intravenous dose of remifentanil per anesthesia hour and body weight in two groups of pediatric surgical patients - an interventional group with remifentanil infusion under pupillometry monitoring, and control group without pupillometry - to figure out whether pupillometry monitoring may reduce remifentanil consumption during anesthesia while providing sufficient analgesia for surgical noxious stimuli.

Condition or disease Intervention/treatment Phase
Opioid Use Device: Pupillometry Not Applicable

Detailed Description:
comparison of total used opioid

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: Interventional group: remifentanil infusion under pupillometry monitoring. Control group: remifentanil infusion without pupillometry monitoring (remifentanil dose is determined by conventional method, i. e., hemodynamic change probably related to noxious stimuli)
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description:

Participant does not know in which of the groups he/she is allocated. Only a care provider (an attending anesthesiologist who is responsible for the patient's anesthesia) knows the group which the patient belongs to.

Investigator and outcomes assessor does not know in which of the groups the patient is allocated, since the group name will be just recorded as "A" or "B" until data analysis of the last participant is done.

Primary Purpose: Treatment
Official Title: Comparison of Remifentanil Consumption in Pupillometry-guided Versus Conventional Administration in Pediatric Surgery: a Prospective, Randomized Controlled Trial
Actual Study Start Date : December 4, 2018
Estimated Primary Completion Date : November 18, 2020
Estimated Study Completion Date : November 18, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Pupillometry group
A group of participants who receive remifentanil infusion under pupillometry monitoring.
Device: Pupillometry
After induction of anesthesia and determination of the loss of consciousness of the participant, baseline diameter of pupil is measured by electronic pupillometry device. During anesthesia, participant's pupil diameter is repeatedly measured with 5-minute interval. Pupil dilation of 30% or more compared to baseline is indicative of insufficient analgesia.

No Intervention: Conventional group
A group of participants who receive remifentanil infusion without pupillometry monitoring; their analgesic dose is mainly determined via hemodyamic change.



Primary Outcome Measures :
  1. remifentanil total dose in microgram [ Time Frame: from beginning of anesthesia to the end of the anesthesia ]
    Remifentanil total dose divided by anesthesia time (minute) and patient weight (kg).

  2. FLACC score [ Time Frame: Arrival at the post-anesthesia care unit ]
    FLACC score (a pain evaluation method for children who cannot express their severity of pain verbally) right after post-anesthesia care unit arrival.

  3. Adjusted analgesic dose after anesthesia [ Time Frame: 24 hours after the end of anesthesia ]
    Total dose of analgesics (NSAIDs and opioids) delivered to the patient since the end of the anesthesia, until 24 hours after the end of anesthesia


Secondary Outcome Measures :
  1. Emergence time [ Time Frame: Intraoperative ]
    Time between the end of the surgery and extubation

  2. Incidence of rescue therapy [ Time Frame: Intraoperative ]
    Incidence of vasopressor/inotropics/anticholinergics/fluid/vasodilators administered, due to moderate to severe hemodynamic change



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

Inclusion Criteria:

  • Pediatric patients who are at 3 to 6 years of age, scheduled to undergo elective surgery with estimated time of operation 2 hours or longer, under general anesthesia
  • American Society of Anesthesiologists physical status classification (ASA class) I - II
  • Patient and his/her parents are willing to participate after explanation of the purpose, materials, methods, possible risks and benefits of the research

Exclusion Criteria:

  • History of hypersensitivity/allergic reaction to the drugs which are used in general anesthesia
  • Preoperative use of analgesics, antipsychotics and/or antiepileptics
  • Mental retardation
  • Medications related to hindrance of autonomic nerve system activity, e. g., beta blockers
  • Underlying ophthalmic diseases

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03749811


Contacts
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Contact: Hee-Soo Kim, M.D., Ph.D. +82-2-2072-3664 dami0605@snu.ac.kr
Contact: Sang-Whan Ji +82-2-2072-3661 taepoongshin@gmail.com

Locations
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Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of
Contact: Heesoo Kim         
Sponsors and Collaborators
Seoul National University Hospital
Investigators
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Principal Investigator: Hee-Soo Kim, M.D., Ph.D. Dept. of Anesthesiology and Pain Medicine, Seoul National University Hospital
Publications of Results:
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Responsible Party: Hee-Soo Kim, princial investigator, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT03749811    
Other Study ID Numbers: 1811-036-984
First Posted: November 21, 2018    Key Record Dates
Last Update Posted: March 29, 2019
Last Verified: March 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
Keywords provided by Hee-Soo Kim, Seoul National University Hospital:
Pupil dilatory reflex
Remifentanil
Analgesia