Does Ketamine Attenuate Depression of Respiratory and Cardiac Functions

The Effect of Small-dose Ketamine on Depression of Respiratory and Cardiac Functions Caused by Propofol in Pediatric Cardiac Catheterization

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01501786

Enrollment

150

Registered

2011-12-29

Start date

2012-01-31

Completion date

2013-05-31

Last updated

2013-07-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Congenital Heart Disease, Sedated for Cardiac Catheterization

Keywords

children, sedation, propofol, ketamine

Brief summary

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.

Interventions

DRUGcontrol

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

DRUGKet10

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

DRUGKet20

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

6 Months to 10 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
difference of end tidal partial pressure of carbon dioxide between the groups	30 and 60 min after anesthetic induction
difference of partial pressure of arterial carbon dioxide between the groups	60 min after anesthetic induction on average
heart rate change from baseline value	30 and 60 min after anesthetic induction
non-invasive blood pressure change from baseline value	30 and 60 min after anesthetic induction

Secondary

Measure	Time frame	Description
movement at topical anesthetic injection	20 min after anesthetic induction on average	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)
the number of times that secreted saliva is aspirated by an attending anesthesiologist	From anesthetic induction to termination of anethetics administration, which is not over 2 hours from anesthetic induction	—

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026