NCT02909413

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2016

Longer than P75 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 27, 2016

Completed
5 months until next milestone

First Posted

Study publicly available on registry

September 21, 2016

Completed
10 days until next milestone

Study Start

First participant enrolled

October 1, 2016

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2020

Completed
Last Updated

September 21, 2016

Status Verified

September 1, 2016

Enrollment Period

3 years

First QC Date

April 27, 2016

Last Update Submit

September 16, 2016

Conditions

Postoperative Cognitive Dysfunction

Keywords

desfluranesevoflurane

Outcome Measures

Primary Outcomes (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.

    Within 7 days after operation

Secondary Outcomes (13)

  • age

    1 day before operation

  • male

    1 day before operation

  • height

    1 day before operation

  • weight

    preoperation

  • previous operation history

    preoperation

  • +8 more secondary outcomes

Study Arms (2)

Group Desflurane

EXPERIMENTAL

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.

Drug: Desflurane

Group Sevoflurane

ACTIVE COMPARATOR

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.

Drug: sevoflurane

Interventions

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.

Group 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.

Group Sevoflurane

Eligibility Criteria

Age6 Years - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (9)

  • 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.

    PMID: 22613422RESULT

  • 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.

    PMID: 12817919RESULT

  • 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.

    PMID: 15728054RESULT

  • 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.

    PMID: 19224088RESULT

  • 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.

    PMID: 20042477RESULT

  • 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.

    PMID: 23043512RESULT

  • 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.

    PMID: 19820242RESULT

  • 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.

    PMID: 12707126RESULT

  • 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.

    PMID: 25638572RESULT

MeSH Terms

Conditions

Postoperative Cognitive Complications

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsCognitive DysfunctionCognition DisordersNeurocognitive DisordersMental Disorders

Central Study Contacts

Yingjie Du, MD

CONTACT

+86-18940252852duyingjiemazui@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Anesthesiology residency

Study Record Dates

First Submitted

April 27, 2016

First Posted

September 21, 2016

Study Start

October 1, 2016

Primary Completion

October 1, 2019

Study Completion

October 1, 2020

Last Updated

September 21, 2016

Record last verified: 2016-09