Does Ketamine Attenuate Depression of Respiratory and Cardiac Functions

Ibaraki Children's Hospital150 enrolled

Overview

Normal cardiac and respiratory functions should be maintained during pediatric cardiac catheterization. Propofol has become a popular choice for sedation in children, however, it depresses cardiac and respiratory functions. Some investigators reported that ketamine attenuates its depressant effect, but it remains unclear whether ketamine reduces cardiac and respiratory depression caused by propofol in pediatric cardiac catheterization.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

TRIPLE

Enrollment

150

Conditions

Congenital Heart Disease Sedated for Cardiac Catheterization

Interventions

controlDRUG

propofol 8mg/kg/h saline 0.24 ml/kg/h

Ket10DRUG

propofol 6.4 mg/kg/h ketamine 10 microg/kg/min

Ket20DRUG

propofol 4.8 mg/kg/h ketamine 20 microg/kg/min

Eligibility

Sex: ALLMin age: 6 MonthsMax age: 10 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 7kg-25kg (6mo-10yrs) children who undergo cardiac catheterization Exclusion Criteria: * patients who have neurological disease, * endocrinological disease, * airway anomaly, who require positive pressure ventilation

Locations (1)

Ibaraki Children's Hospital

Mito, Ibaraki, Japan

Outcomes

Primary Outcomes

difference of end tidal partial pressure of carbon dioxide between the groups

Time frame: 30 and 60 min after anesthetic induction

difference of partial pressure of arterial carbon dioxide between the groups

Time frame: 60 min after anesthetic induction on average

heart rate change from baseline value

Time frame: 30 and 60 min after anesthetic induction

non-invasive blood pressure change from baseline value

Time frame: 30 and 60 min after anesthetic induction

Secondary Outcomes

movement at topical anesthetic injection

1. none (no movement or slight movement unnecessary to restrain) 2. mild (movement necessary to restrain, limited to lower extremities) 3. moderate (strong movement of lower extremities and movement of upper extremities unvecessary to restrain) 4. severe (movement necessary to restrain upper extremities and body trunk in addition to lower extremities, or some vacalization)

Time frame: 20 min after anesthetic induction on average

the number of times that secreted saliva is aspirated by an attending anesthesiologist

Time frame: From anesthetic induction to termination of anethetics administration, which is not over 2 hours from anesthetic induction

Data from ClinicalTrials.gov

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