Recruiting

DexmedetomidineDexmedetomidine Effect on Mitochondrial Function

Sponsor:

The Hospital for Sick Children

Code:

NCT02299063

Conditions

Complication of Anesthesia

Ischaemia-reperfusion Injury

Eligibility Criteria

Sex: All

Age: 0 - 3

Healthy Volunteers: Not accepted

Interventions

Dexmedetomidine

0.9% NaCl

Study Details

Brief summary:

The investigators hypothesize that in addition to a known sympatholytic effect, intraoperative dexmedetomidine reduces adverse changes in mitochondrial function and structure attenuating ischaemia-reperfusion and end-organ injury for children with non cyanotic congenital heart defects having corrective heart surgery.

Conditions

Complication of Anesthesia

Ischaemia-reperfusion Injury

Study ID

NCT02299063

Start date

Nov, 2014

Status verified date

May, 2018

Completion date

Dec, 2019

Anticipated

Primary completion date

Dec, 2019

Anticipated

Eligibility Criteria

Sex: All

Age: 0 - 3

Healthy Volunteers: Not accepted

Inclusion Criteria:

aged between 3 - 36 months
having primary corrective heart surgery

Exclusion Criteria:

recent surgery (< 3 months)
previous chemotherapy
previous transfusion of blood products
neurodevelopmental disorders (including Trisomy 21)
supplemental oxygen requirement (< 3 months)
asthma requiring regular therapy
obstructive sleep apnea
the presence of concurrent infection or inflammation
a known allergy to dexmedetomidine hydrochloride

Study Design

Enrollment

36 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

placebo comparator: Placebo (0.9% Saline)

0.9% Saline: bolus dose of 0.125mL/kg infused over 10 minutes, followed by a continuous infusion (CI) dose at 0.15mL/kg/hr for the duration of surgery.

experimental: Dexmedetomidine

Dexmedetomidine: bolus dose of 0.5 mcg/kg infused over 10 minutes, followed by a continuous infusion (CI) dose at 0.6 mcg/kg/hr for the duration of surgery.

Interventions

Dexmedetomidine

A bolus dose of 0.5 mcg/kg infused over 10 minutes will be administered, followed by a continuous infusion for the duration of the surgery at 0.6 mcg/kg/hr.

0.9% NaCl

Primary outcome measure

Mitochondrial function (use high content imaging (HCI) [ Time Frame: Intraoperative ]

Central Contacts and Locations

Central contacts

James D O'Leary, MBBCh

(416) 813-1500 james.oleary@sickkids.ca

Locations

Hospital for Sick Children

Recruiting

Toronto, Ontario, Canada, M5G1X8

Principal Investigator:

James D O'Leary, MBBCh

More Information

Sponsor

The Hospital for Sick Children

Last update posted

May 9, 2018

Last verified

May, 2018

Keywords

Mitochondria
Dexmedetomidine
Heart Defects, Congenital

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The Hospital for Sick Children on 2018-05-09.