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

Not Applicable

• Conditions: Postoperative Cognitive Dysfunction
• Interventions: Drug: Desflurane; Drug: sevoflurane

• Registration Number: NCT02909413
• Lead Sponsor: Shengjing Hospital

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.

Study Timeline

• Study First Submitted: 2016-04-27
• Status Verified: 2016-09
• Study First Submitted QC: 2016-09-16
• Last Update Submitted: 2016-09-16
• Study First Posted: 2016-09-21
• Last Update Posted: 2016-09-21
• Study Start: 2016-10
• Primary Completion: 2019-10
• Study Completion: 2020-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 600

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.

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group Desflurane	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 Sevoflurane	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.

Primary Outcome Measures

Name	Time	Method
The incidence of postoperative cognitive dysfunction	Within 7 days after operation	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

Name	Time	Method
age	1 day before operation	years old
male	1 day before operation	If the child is boy,it's "yes",or it's "no".
height	1 day before operation	CM
weight	preoperation	kg
previous operation history	preoperation	If the child had previous operation history,it's "yes",or it's "no".
the duration of anesthesia	From the time began to give the anesthetic to the time of pull out the endotracheal intubation	minutes
the duration of operation	Surgery end time minus the start time	minutes
total blood loss	The total blood loss of the whole surgery time.	ml
total volume of infusion	The total volume of infusion of the whole surgery time.	ml
whether there is respiratory depression in postanesthesia care unit	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.	If the child has respiratory depression during this time,it's "yes",or it's "no".
the length of hospital stay	the time from admission to hospital to discharge from hospital,the estimated period is up to 5 days.	days
S100β	1 day after surgery	obtain the children's plasma to detection S100β with ELEASE.
NSE	1 day after surgery	obtain the children's plasma to detection NSE with ELEASE.