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

NCT ID: NCT02909413

Last Updated: 2016-09-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-31

Study Completion Date

2020-10-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Postoperative Cognitive Dysfunction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Group Desflurane

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.

Group Type EXPERIMENTAL

Desflurane

Intervention Type DRUG

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 Sevoflurane

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.

Group Type ACTIVE_COMPARATOR

sevoflurane

Intervention Type DRUG

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.

Interventions

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Desflurane

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

sevoflurane

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.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

6 Years

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shengjing Hospital

OTHER

Sponsor Role lead

Responsible Party

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Yingjie Du

Anesthesiology residency

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Yingjie Du, MD

Role: CONTACT

+86-18940252852

References

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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.

Reference Type RESULT
PMID: 22613422 (View on PubMed)

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.

Reference Type RESULT
PMID: 12817919 (View on PubMed)

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.

Reference Type RESULT
PMID: 15728054 (View on PubMed)

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.

Reference Type RESULT
PMID: 19224088 (View on PubMed)

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.

Reference Type RESULT
PMID: 20042477 (View on PubMed)

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.

Reference Type RESULT
PMID: 23043512 (View on PubMed)

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.

Reference Type RESULT
PMID: 19820242 (View on PubMed)

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.

Reference Type RESULT
PMID: 12707126 (View on PubMed)

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.

Reference Type RESULT
PMID: 25638572 (View on PubMed)

Other Identifiers

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DES VS. SEV

Identifier Type: -

Identifier Source: org_study_id

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