search
Back to results

Comparison of Desflurane With Sevoflurane for School-age Children in Postoperative Cognitive Function

Primary Purpose

Postoperative Cognitive Dysfunction

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Desflurane
sevoflurane
Sponsored by
Shengjing Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Postoperative Cognitive Dysfunction focused on measuring desflurane, sevoflurane

Eligibility Criteria

6 Years - 14 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 6-14 age, elective no-cardiac and non-neurological surgery , ASA physical statusⅠorⅡ, no preoperative cognitive function impairment, cooperate to complete the entire test.

Exclusion Criteria:

  • Allergic to halogens inhaled anesthetics, malignant hyperthermia susceptible patients, intracranial hypertension, emotional disorder, hyperactivity, history of operation, mental retardation, audio-visual obstacles, history of congenital heart disease, Important organ dysfunction, history of drug abuse
  • History of epilepsy
  • Preoperative respiratory infection significantly.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Group Desflurane

    Group Sevoflurane

    Arm Description

    Anesthesia maintenance: After endotracheal intubation, patients will be randomized into Desflurane for maintenance. The gas flow rate of Desflurane group is 2 L/min, include 50％ O2 and 4～5％ Desflurane.

    Anesthesia maintenance: After endotracheal intubation, patients will be randomized into sevoflurane for maintenance. The gas flow rate of Sevoflurane group is 2L/ min, include 50％O2 and 1.7-2.0% Sevoflurane.

    Outcomes

    Primary Outcome Measures

    The incidence of postoperative cognitive dysfunction
    Cognitive function score should be carried out for all children at preoperative 1d, postoperative 2 d, 3d and 7d. If postoperative score compared with preoperative score drop 1 points or more, then postoperative cognitive dysfunction will be recorded.

    Secondary Outcome Measures

    age
    years old
    male
    If the child is boy,it's "yes",or it's "no".
    height
    CM
    weight
    kg
    previous operation history
    If the child had previous operation history,it's "yes",or it's "no".
    the duration of anesthesia
    minutes
    the duration of operation
    minutes
    total blood loss
    ml
    total volume of infusion
    ml
    whether there is respiratory depression in postanesthesia care unit
    If the child has respiratory depression during this time,it's "yes",or it's "no".
    the length of hospital stay
    days
    S100β
    obtain the children's plasma to detection S100β with ELEASE.
    NSE
    obtain the children's plasma to detection NSE with ELEASE.

    Full Information

    First Posted
    April 27, 2016
    Last Updated
    September 16, 2016
    Sponsor
    Shengjing Hospital
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT02909413
    Brief Title
    Comparison of Desflurane With Sevoflurane for School-age Children in Postoperative Cognitive Function
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    October 2016 (undefined)
    Primary Completion Date
    October 2019 (Anticipated)
    Study Completion Date
    October 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Shengjing Hospital

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This study compares desflurane with sevoflurane for school-age children in postoperative cognitive function.
    Detailed Description
    The postoperative cognitive dysfunction (POCD) of school-age children (6-14 age) after operation draw more attention from both society and family. It is well known that, compare with sevoflurane, desflurane could improve cognitive function in elderly patients. But whether Desflurane could improve postoperative cognitive function compare with Sevoflurane for the school-age children, there is no consistent conclusion.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Postoperative Cognitive Dysfunction
    Keywords
    desflurane, sevoflurane

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    600 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Group Desflurane
    Arm Type
    Experimental
    Arm Description
    Anesthesia maintenance: After endotracheal intubation, patients will be randomized into Desflurane for maintenance. The gas flow rate of Desflurane group is 2 L/min, include 50％ O2 and 4～5％ Desflurane.
    Arm Title
    Group Sevoflurane
    Arm Type
    Active Comparator
    Arm Description
    Anesthesia maintenance: After endotracheal intubation, patients will be randomized into sevoflurane for maintenance. The gas flow rate of Sevoflurane group is 2L/ min, include 50％O2 and 1.7-2.0% Sevoflurane.
    Intervention Type
    Drug
    Intervention Name(s)
    Desflurane
    Intervention Description
    Anesthesia maintenance: After endotracheal intubation, half of the patients will be randomized into Desflurane Group. The gas flow rate of Desflurane group is 2 L/min, include 50％ O2 and 4～5％ Desflurane.
    Intervention Type
    Drug
    Intervention Name(s)
    sevoflurane
    Intervention Description
    Anesthesia maintenance: After endotracheal intubation, half of the patients will be randomized into Sevoflurane Group. The gas flow rate of Desflurane group is 2 L/min, 50％O2 and 1.7-2.0% Sevoflurane.
    Primary Outcome Measure Information:
    Title
    The incidence of postoperative cognitive dysfunction
    Description
    Cognitive function score should be carried out for all children at preoperative 1d, postoperative 2 d, 3d and 7d. If postoperative score compared with preoperative score drop 1 points or more, then postoperative cognitive dysfunction will be recorded.
    Time Frame
    Within 7 days after operation
    Secondary Outcome Measure Information:
    Title
    age
    Description
    years old
    Time Frame
    1 day before operation
    Title
    male
    Description
    If the child is boy,it's "yes",or it's "no".
    Time Frame
    1 day before operation
    Title
    height
    Description
    CM
    Time Frame
    1 day before operation
    Title
    weight
    Description
    kg
    Time Frame
    preoperation
    Title
    previous operation history
    Description
    If the child had previous operation history,it's "yes",or it's "no".
    Time Frame
    preoperation
    Title
    the duration of anesthesia
    Description
    minutes
    Time Frame
    From the time began to give the anesthetic to the time of pull out the endotracheal intubation
    Title
    the duration of operation
    Description
    minutes
    Time Frame
    Surgery end time minus the start time
    Title
    total blood loss
    Description
    ml
    Time Frame
    The total blood loss of the whole surgery time.
    Title
    total volume of infusion
    Description
    ml
    Time Frame
    The total volume of infusion of the whole surgery time.
    Title
    whether there is respiratory depression in postanesthesia care unit
    Description
    If the child has respiratory depression during this time,it's "yes",or it's "no".
    Time Frame
    The period which the patient stay at post anesthesia care unit,from the time enter to postanesthesia care unit to the time leave postanesthesia care unit,the estimated period is up to 30 minutes.
    Title
    the length of hospital stay
    Description
    days
    Time Frame
    the time from admission to hospital to discharge from hospital,the estimated period is up to 5 days.
    Title
    S100β
    Description
    obtain the children's plasma to detection S100β with ELEASE.
    Time Frame
    1 day after surgery
    Title
    NSE
    Description
    obtain the children's plasma to detection NSE with ELEASE.
    Time Frame
    1 day after surgery

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    6 Years
    Maximum Age & Unit of Time
    14 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 6-14 age, elective no-cardiac and non-neurological surgery , ASA physical statusⅠorⅡ, no preoperative cognitive function impairment, cooperate to complete the entire test. Exclusion Criteria: Allergic to halogens inhaled anesthetics, malignant hyperthermia susceptible patients, intracranial hypertension, emotional disorder, hyperactivity, history of operation, mental retardation, audio-visual obstacles, history of congenital heart disease, Important organ dysfunction, history of drug abuse History of epilepsy Preoperative respiratory infection significantly.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Yingjie Du, MD
    Phone
    +86-18940252852
    Email
    duyingjiemazui@163.com

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    22613422
    Citation
    Radtke FM, Franck M, Herbig TS, Papkalla N, Kleinwaechter R, Kork F, Brockhaus WR, Wernecke KD, Spies CD. Incidence and risk factors for cognitive dysfunction in patients with severe systemic disease. J Int Med Res. 2012;40(2):612-20. doi: 10.1177/147323001204000223.
    Results Reference
    result
    PubMed Identifier
    12817919
    Citation
    Bekker AY, Weeks EJ. Cognitive function after anaesthesia in the elderly. Best Pract Res Clin Anaesthesiol. 2003 Jun;17(2):259-72. doi: 10.1016/s1521-6896(03)00005-3.
    Results Reference
    result
    PubMed Identifier
    15728054
    Citation
    Mckay RE, Large MJC, Balea MC, Mckay WR. Airway reflexes return more rapidly after desflurane anesthesia than after sevoflurane anesthesia. Anesth Analg. 2005 Mar;100(3):697-700. doi: 10.1213/01.ANE.0000146514.65070.AE.
    Results Reference
    result
    PubMed Identifier
    19224088
    Citation
    Arslan M, Kurtipek O, Dogan AT, Unal Y, Kizil Y, Nurlu N, Kamaci S, Kavutcu M. Comparison of effects of anaesthesia with desflurane and enflurane on liver function. Singapore Med J. 2009 Jan;50(1):73-7.
    Results Reference
    result
    PubMed Identifier
    20042477
    Citation
    Rortgen D, Kloos J, Fries M, Grottke O, Rex S, Rossaint R, Coburn M. Comparison of early cognitive function and recovery after desflurane or sevoflurane anaesthesia in the elderly: a double-blinded randomized controlled trial. Br J Anaesth. 2010 Feb;104(2):167-74. doi: 10.1093/bja/aep369. Epub 2009 Dec 30.
    Results Reference
    result
    PubMed Identifier
    23043512
    Citation
    Locatelli BG, Ingelmo PM, Emre S, Meroni V, Minardi C, Frawley G, Benigni A, Di Marco S, Spotti A, Busi I, Sonzogni V. Emergence delirium in children: a comparison of sevoflurane and desflurane anesthesia using the Paediatric Anesthesia Emergence Delirium scale. Paediatr Anaesth. 2013 Apr;23(4):301-8. doi: 10.1111/pan.12038. Epub 2012 Oct 9.
    Results Reference
    result
    PubMed Identifier
    19820242
    Citation
    Dexter F, Bayman EO, Epstein RH. Statistical modeling of average and variability of time to extubation for meta-analysis comparing desflurane to sevoflurane. Anesth Analg. 2010 Feb 1;110(2):570-80. doi: 10.1213/ANE.0b013e3181b5dcb7. Epub 2009 Oct 9.
    Results Reference
    result
    PubMed Identifier
    12707126
    Citation
    Valley RD, Freid EB, Bailey AG, Kopp VJ, Georges LS, Fletcher J, Keifer A. Tracheal extubation of deeply anesthetized pediatric patients: a comparison of desflurane and sevoflurane. Anesth Analg. 2003 May;96(5):1320-1324. doi: 10.1213/01.ANE.0000058844.77403.16.
    Results Reference
    result
    PubMed Identifier
    25638572
    Citation
    Tachibana S, Hayase T, Osuda M, Kazuma S, Yamakage M. Recovery of postoperative cognitive function in elderly patients after a long duration of desflurane anesthesia: a pilot study. J Anesth. 2015 Aug;29(4):627-30. doi: 10.1007/s00540-015-1979-y. Epub 2015 Feb 1.
    Results Reference
    result

    Learn more about this trial

    Comparison of Desflurane With Sevoflurane for School-age Children in Postoperative Cognitive Function

    We'll reach out to this number within 24 hrs