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Completed

NCT Number: NCT01501786

Does Ketamine Attenuate Depression of Respiratory and Cardiac Functions

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.

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Key information

Conditions

Congenital Heart Disease Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases Sedated for Cardiac Catheterization

Age range

6 month–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ibaraki Children's Hospital

Mito, Ibaraki, 311-4145, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Control

Drug

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

Other names: saline with propofol

Ket10

Drug

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

Other names: ketamine 10 γ

Ket20

Drug

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

Other names: ketamine 20 γ

Primary outcomes

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

    Time frame: 30 and 60 min after anesthetic induction

  2. difference of partial pressure of arterial carbon dioxide between the groups

    Time frame: 60 min after anesthetic induction on average

  3. heart rate change from baseline value

    Time frame: 30 and 60 min after anesthetic induction

  4. non-invasive blood pressure change from baseline value

    Time frame: 30 and 60 min after anesthetic induction

Secondary outcomes

  1. movement at topical anesthetic injection

    Time frame: 20 min after anesthetic induction on average

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

  2. 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

Sponsors and collaborators

Lead sponsor

Ibaraki Children's Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Dec 29, 2011
Registry last updated
Jul 30, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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