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

Postoperative Cognitive Dysfunction Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02909413
• Other study ID #: DES VS. SEV
• Status: Not yet recruiting
• Phase: N/A
• First received: April 27, 2016
• Last updated: September 16, 2016
• Start date: October 2016
• Est. completion date: October 2020

Study information

• Verified date: September 2016
• Source: Shengjing Hospital
• Contact: Yingjie Du, MD
• Phone: +86-18940252852
• Email: duyingjiemazui[@]163.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 600
• Est. completion date: October 2020
• Est. primary completion date: October 2019
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 14 Years

Eligibility

Inclusion Criteria:

• 6-14 age, elective no-cardiac and non-neurological surgery , ASA physical status?or?, 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Postoperative Cognitive Dysfunction

Intervention

Drug:
• Des?urane
Anesthesia maintenance: After endotracheal intubation, half of the patients will be randomized into Des?urane Group. The gas flow rate of Desflurane group is 2 L/min, include 50% O2 and 4~5% Desflurane.
• sevo?urane
Anesthesia maintenance: After endotracheal intubation, half of the patients will be randomized into Sevo?urane Group. The gas flow rate of Desflurane group is 2 L/min, 50%O2 and 1.7-2.0% Sevoflurane.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shengjing Hospital

References & Publications (9)

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. — View Citation

Bekker AY, Weeks EJ. Cognitive function after anaesthesia in the elderly. Best Pract Res Clin Anaesthesiol. 2003 Jun;17(2):259-72. Review. — View 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. — View 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 — View Citation

McKay RE, Large MJ, Balea MC, McKay WR. Airway reflexes return more rapidly after desflurane anesthesia than after sevoflurane anesthesia. Anesth Analg. 2005 Mar;100(3):697-700, table of contents. — View 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. — View Citation

Rörtgen 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 — View 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 201 — View 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):1320-4, table of contents. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	age	years old	1 day before operation	Yes
Secondary	male	If the child is boy,it's "yes",or it's "no".	1 day before operation	Yes
Secondary	height	CM	1 day before operation	Yes
Secondary	weight	kg	preoperation	Yes
Secondary	previous operation history	If the child had previous operation history,it's "yes",or it's "no".	preoperation	Yes
Secondary	the duration of anesthesia	minutes	From the time began to give the anesthetic to the time of pull out the endotracheal intubation	Yes
Secondary	the duration of operation	minutes	Surgery end time minus the start time	Yes
Secondary	total blood loss	ml	The total blood loss of the whole surgery time.	Yes
Secondary	total volume of infusion	ml	The total volume of infusion of the whole surgery time.	Yes
Secondary	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 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.	Yes
Secondary	the length of hospital stay	days	the time from admission to hospital to discharge from hospital,the estimated period is up to 5 days.	Yes
Secondary	S100ß	obtain the children's plasma to detection S100ß with ELEASE.	1 day after surgery	Yes
Secondary	NSE	obtain the children's plasma to detection NSE with ELEASE.	1 day after surgery	Yes