Does Ketamine Attenuate Depression of Respiratory and Cardiac Functions

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kazuhiko Okuyama, MD, Ibaraki Children's Hospital
ClinicalTrials.gov Identifier:
NCT01501786
First received: December 10, 2011
Last updated: July 28, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention
Congenital Heart Disease
Sedated for Cardiac Catheterization
Drug: control
Drug: Ket10
Drug: Ket20

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: The Effect of Small-dose Ketamine on Depression of Respiratory and Cardiac Functions Caused by Propofol in Pediatric Cardiac Catheterization

Resource links provided by NLM:


Further study details as provided by Ibaraki Children's Hospital:

Primary Outcome Measures:
  • difference of end tidal partial pressure of carbon dioxide between the groups [ Time Frame: 30 and 60 min after anesthetic induction ] [ Designated as safety issue: No ]
  • difference of partial pressure of arterial carbon dioxide between the groups [ Time Frame: 60 min after anesthetic induction on average ] [ Designated as safety issue: No ]
  • heart rate change from baseline value [ Time Frame: 30 and 60 min after anesthetic induction ] [ Designated as safety issue: No ]
  • non-invasive blood pressure change from baseline value [ Time Frame: 30 and 60 min after anesthetic induction ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • movement at topical anesthetic injection [ Time Frame: 20 min after anesthetic induction on average ] [ Designated as safety issue: No ]
    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 [ Time Frame: From anesthetic induction to termination of anethetics administration, which is not over 2 hours from anesthetic induction ] [ Designated as safety issue: No ]

Enrollment: 150
Study Start Date: January 2012
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Sham Comparator: control
propofol and saline are administered
Drug: control
propofol 8mg/kg/h saline 0.24 ml/kg/h
Other Name: saline with propofol
Experimental: Ket10
ketamine is co-administered with propofol
Drug: Ket10
propofol 6.4 mg/kg/h ketamine 10 microg/kg/min
Other Name: ketamine 10 γ
Experimental: Ket20
ketamine is co-administered with porpofol
Drug: Ket20
propofol 4.8 mg/kg/h ketamine 20 microg/kg/min
Other Name: ketamine 20 γ

  Eligibility

Ages Eligible for Study:   6 Months to 10 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01501786

Locations
Japan
Ibaraki Children's Hospital
Mito, Ibaraki, Japan, 311-4145
Sponsors and Collaborators
Ibaraki Children's Hospital
Investigators
Study Chair: Kazuhiko Okuyama, MD Ibaraki Children's Hospital
Principal Investigator: Yuki Takeda, MD Ibaraki Children's Hospital
  More Information

No publications provided

Responsible Party: Kazuhiko Okuyama, MD, Head of Anesthesiology department, Ibaraki Children's Hospital
ClinicalTrials.gov Identifier: NCT01501786     History of Changes
Other Study ID Numbers: ketamine in sedation
Study First Received: December 10, 2011
Last Updated: July 28, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Ibaraki Children's Hospital:
children
sedation
propofol
ketamine

Additional relevant MeSH terms:
Depression
Heart Defects, Congenital
Heart Diseases
Behavioral Symptoms
Cardiovascular Abnormalities
Cardiovascular Diseases
Congenital Abnormalities
Ketamine
Propofol
Analgesics
Anesthetics
Anesthetics, Dissociative
Anesthetics, General
Anesthetics, Intravenous
Central Nervous System Agents
Central Nervous System Depressants
Excitatory Amino Acid Agents
Excitatory Amino Acid Antagonists
Hypnotics and Sedatives
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014