NCT03024840

Brief Summary

To study the effect of different anaesthetic methods on pediatric neurocognitive development and cerebral injury during pediatric living related liver transplantation .

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2016

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2016

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

December 23, 2016

Completed
27 days until next milestone

First Posted

Study publicly available on registry

January 19, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

January 19, 2017

Status Verified

January 1, 2017

Enrollment Period

5 months

First QC Date

December 23, 2016

Last Update Submit

January 15, 2017

Conditions

Liver TransplantationChildren

Keywords

PropofolNeurocognitive DisordersLiver transplantationPediatricsBrain Injuries

Outcome Measures

Primary Outcomes (2)

  • Evidence of cerebral injury including S-100 β protein, neurospecific enolase confirmed by electrochemiluminescence

    before skin incision, 0.5 hour after anhepatic,1 hour of neohepatic stage,the end of surgery,24 hours after operation

  • Evidences of inflammatory factor such as interleukin-6，interleukin-10，et al confirmed by electrochemiluminescence

    before skin incision, 0.5 hour after anhepatic,1 hour of neohepatic stage,the end of surgery,24 hours after operation

Secondary Outcomes (3)

  • Evaluation of neurocognitive disorder using Bayley Scales of Infant Development

    1 day before surgery, 7days,14 days and 21days of post-operation

  • Evaluation of delirium using Pediatric Anesthesia Emergence Delirium

    Within 1 days after extubation

  • hemodynamics index

    before skin incision, 0.5 hour after anhepatic,1 hour of neohepatic stage,the end of surgery,24 hours after operation

Study Arms (2)

sevoflurane

EXPERIMENTAL

Sevoflurane is inhalated with 1%-2% after anesthesia induction until end of the surgery.

Drug: Sevoflurane

propofol

EXPERIMENTAL

Propofol is injected with 9-15 mg/kg/h after anesthesia induction until end of the surgery.

Drug: Propofol

Interventions

SevofluraneDRUG

Sevoflurane: 1%\~2%

sevoflurane
PropofolDRUG

Propofol: 9-15 mg/kg/h

propofol

Eligibility Criteria

Age4 Months - 12 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children with end-stage liver disease Children with biliary atresia

You may not qualify if:

  • pre-existing cerebral disease second liver transplantation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

No.24 Fukang Road,Nankai District

Tianjin, Tianjin Municipality, 300192, China

Location

MeSH Terms

Conditions

Neurocognitive DisordersBrain Injuries

Interventions

SevofluranePropofol

Condition Hierarchy (Ancestors)

Mental DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Intervention Hierarchy (Ancestors)

Methyl EthersEthersOrganic ChemicalsHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbonsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, Cyclic

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Wenli Yu,PhD ,Department of Anesthesiology,Tianjin First Center Hospital

Study Record Dates

First Submitted

December 23, 2016

First Posted

January 19, 2017

Study Start

December 1, 2016

Primary Completion

May 1, 2017

Study Completion

December 1, 2017

Last Updated

January 19, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)