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Postoperative Cognitive DysfunctionNCT02909413

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

A study testing Desflurane and sevoflurane in people with Postoperative Cognitive Dysfunction, run by Shengjing Hospital.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This study compares desflurane with sevoflurane for school-age children in postoperative cognitive function. Read more about this study

Who is it for?
Ages 6 to 14 years
Conditions the study is for
Postoperative Cognitive Dysfunction
What is being tested?
Desflurane and sevoflurane
Could I receive a placebo?
No, everyone receives an active treatment
How many people
600 participants
Where
No sites listed yet
Study dates
Oct 2016to Oct 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 14 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

No sites are listed yet.

Yingjie Du, MD contact

+86-18940252852

duyingjiemazui@163.com

About this study

This study compares desflurane with sevoflurane for school-age children in postoperative cognitive function.

Read the 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.

Being tested
Desflurane, sevoflurane
Keywords
desflurane, sevoflurane
Medical subject headings
Postoperative Cognitive Complications

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DesfluraneDrug

    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.

  • sevofluraneDrug

    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.

Study groups in NCT02909413
Study groupRoleWhat they receive
Group DesfluraneExperimentalAnesthesia 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.
Receives: Drug: Desflurane
Group SevofluraneActive comparatorAnesthesia 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.
Receives: Drug: sevoflurane

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Within 7 days after operation

Secondary outcomes (13)

  1. age

    years old

    Measured: 1 day before operation

  2. male

    If the child is boy,it's "yes",or it's "no".

    Measured: 1 day before operation

  3. height

    CM

    Measured: 1 day before operation

  4. weight

    kg

    Measured: preoperation

  5. previous operation history

    If the child had previous operation history,it's "yes",or it's "no".

    Measured: preoperation

  6. the duration of anesthesia

    minutes

    Measured: From the time began to give the anesthetic to the time of pull out the endotracheal intubation

  7. the duration of operation

    minutes

    Measured: Surgery end time minus the start time

  8. total blood loss

    ml

    Measured: The total blood loss of the whole surgery time.

  9. total volume of infusion

    ml

    Measured: The total volume of infusion of the whole surgery time.

  10. 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".

    Measured: 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.

  11. the length of hospital stay

    days

    Measured: the time from admission to hospital to discharge from hospital,the estimated period is up to 5 days.

  12. S100β

    obtain the children's plasma to detection S100β with ELEASE.

    Measured: 1 day after surgery

  13. NSE

    obtain the children's plasma to detection NSE with ELEASE.

    Measured: 1 day after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Sep 2016 (estimated)
  2. Study startOct 2016
  3. Primary completionOct 2019 (estimated)
  4. Study completionOct 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
600 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02909413
Sponsor's protocol ID
DES VS. SEV
Status last verified
Sep 2016
First submitted
27 Apr 2016
Last updated
21 Sep 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 22613422

  • 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.

    PubMed 12817919

  • 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.

    PubMed 15728054

  • 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.

    PubMed 19224088

  • 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.

    PubMed 20042477

  • 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.

    PubMed 23043512

  • 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.

    PubMed 19820242

  • 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.

    PubMed 12707126

  • 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.

    PubMed 25638572

Questions about this trial

What is this clinical trial studying?

A study testing Desflurane and sevoflurane in people with Postoperative Cognitive Dysfunction, run by Shengjing Hospital.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 21 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Yingjie Du, MD (+86-18940252852, duyingjiemazui@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The incidence of postoperative cognitive dysfunction (time frame: Within 7 days after operation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02909413, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2016.

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