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

Sponsor

Shengjing Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT02909413

Collaborator

(none)

600

Enrollment

Arms

Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Postoperative Cognitive Dysfunction	Drug: Desﬂurane Drug: sevoﬂurane	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

600 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Health Services Research

Study Start Date :

Oct 1, 2016

Anticipated Primary Completion Date :

Oct 1, 2019

Anticipated Study Completion Date :

Oct 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Drug: 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.
Active Comparator: 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.	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.

Arm

Intervention/Treatment

Experimental: 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.

Drug: 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.

Active Comparator: 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.

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.

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years to 14 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.