A Study to Compare the Long-term Outcomes After Two Different Anaesthetics

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

450

Participants

Timeline

Start Date

August 10, 2017

Primary Completion Date

March 31, 2026

Study Completion Date

June 30, 2026

Conditions
AnesthesiaNeurotoxicityChild Development
Interventions
DRUG

Sevoflurane

Experimental arm: end tidal concentration of 0.6 -0.8% or less. Active comparator arm: end tidal concentration of 2.5-3.0% or greater.

DRUG

Remifentanil

Experimental arm: loading dose: 1 mcg/kg, infusion starting at 0.1 mcg/kg/min or greater.

DRUG

Dexmedetomidine

Experimental arm: loading dose:1mcg/kg, infusion: 1 mcg/kg/hr.

Trial Locations (21)

2031

Sydney Children's Hospital, Randwick

2145

Children's Hospital at Westmead, Westmead

3052

Royal Children's Hospital, Parkville

4101

Queensland Children's Hospital, Brisbane

5006

Women's and Children's Hospital, Adelaide

5042

Flinders Medical Centre, Bedford Park

6008

Perth Children's Hospital, Perth

19104

The Children's Hospital of Philadelphia, Philadelphia

44195

Cleveland Clinic, Cleveland

75390

The University of Texas Southwestern Medical Center, Dallas

77030

Texas Children's Hospital, Houston

02115

Boston Children's Hospital, Boston

Unknown

Presidio Ospedale Infantile C.Arrigo Azienda Ospedaliera, Alessandria

Azienda ospedaliero-universitaria di Bologna, Bologna

Azienda Ospedaliero-Universitaria Meyer, Florence

Istituto Giannina Gaslini, Genova

Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico - Clinica Mangiagalli, Milan

Vittore Buzzi Children's Hospital, Milan

Azienda Ospedaliero Universitaria Pisana, Pisa

Ospedale Bambino Gesù, Roma

La Paz University Hospital, Madrid

All Listed Sponsors
collaborator

Sydney Children's Hospitals Network

OTHER

collaborator

Baylor College of Medicine

OTHER

collaborator

Boston Children's Hospital

OTHER

collaborator

The Cleveland Clinic

OTHER

collaborator

University of Texas, Southwestern Medical Center at Dallas

OTHER

collaborator

Royal Children's Hospital

OTHER

collaborator

Children's Hospital of Philadelphia

OTHER

collaborator

Queensland Children's Hospital

OTHER_GOV

collaborator

Perth Children's Hospital

UNKNOWN

collaborator

Women and Children's Hospital

UNKNOWN

collaborator

Istituto Giannina Gaslini

OTHER

collaborator

Flinders Medical Centre

OTHER_GOV

lead

Murdoch Childrens Research Institute

OTHER

NCT03089905 - A Study to Compare the Long-term Outcomes After Two Different Anaesthetics | Biotech Hunter | Biotech Hunter