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

September 16, 2016 updated by: Yingjie Du, Shengjing Hospital
This study compares desflurane with sevoflurane for school-age children in postoperative cognitive function.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

600

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 14 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The incidence of postoperative cognitive dysfunction
Time Frame: 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.
Within 7 days after operation

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shengjing Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2016

Primary Completion (Anticipated)

October 1, 2019

Study Completion (Anticipated)

October 1, 2020

Study Registration Dates

First Submitted

April 27, 2016

First Submitted That Met QC Criteria

September 16, 2016

First Posted (Estimate)

September 21, 2016

Study Record Updates

Last Update Posted (Estimate)

September 21, 2016

Last Update Submitted That Met QC Criteria

September 16, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DES VS. SEV

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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