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Does Ketamine Attenuate Depression of Respiratory and Cardiac Functions

Primary Purpose

Congenital Heart Disease, Sedated for Cardiac Catheterization

Status
Completed
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
control
Ket10
Ket20
Sponsored by
Ibaraki Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Congenital Heart Disease focused on measuring children, sedation, propofol, ketamine

Eligibility Criteria

6 Months - 10 Years (Child)All SexesDoes not accept 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

Sites / Locations

  • Ibaraki Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Sham Comparator

Experimental

Experimental

Arm Label

control

Ket10

Ket20

Arm Description

propofol and saline are administered

ketamine is co-administered with propofol

ketamine is co-administered with porpofol

Outcomes

Primary Outcome Measures

difference of end tidal partial pressure of carbon dioxide between the groups
difference of partial pressure of arterial carbon dioxide between the groups
heart rate change from baseline value
non-invasive blood pressure change from baseline value

Secondary Outcome Measures

movement at topical anesthetic injection
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)
the number of times that secreted saliva is aspirated by an attending anesthesiologist

Full Information

First Posted
December 10, 2011
Last Updated
July 28, 2013
Sponsor
Ibaraki Children's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01501786
Brief Title
Does Ketamine Attenuate Depression of Respiratory and Cardiac Functions
Official Title
The Effect of Small-dose Ketamine on Depression of Respiratory and Cardiac Functions Caused by Propofol in Pediatric Cardiac Catheterization
Study Type
Interventional

2. Study Status

Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ibaraki Children's Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congenital Heart Disease, Sedated for Cardiac Catheterization
Keywords
children, sedation, propofol, ketamine

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
control
Arm Type
Sham Comparator
Arm Description
propofol and saline are administered
Arm Title
Ket10
Arm Type
Experimental
Arm Description
ketamine is co-administered with propofol
Arm Title
Ket20
Arm Type
Experimental
Arm Description
ketamine is co-administered with porpofol
Intervention Type
Drug
Intervention Name(s)
control
Other Intervention Name(s)
saline with propofol
Intervention Description
propofol 8mg/kg/h saline 0.24 ml/kg/h
Intervention Type
Drug
Intervention Name(s)
Ket10
Other Intervention Name(s)
ketamine 10 γ
Intervention Description
propofol 6.4 mg/kg/h ketamine 10 microg/kg/min
Intervention Type
Drug
Intervention Name(s)
Ket20
Other Intervention Name(s)
ketamine 20 γ
Intervention Description
propofol 4.8 mg/kg/h ketamine 20 microg/kg/min
Primary Outcome Measure Information:
Title
difference of end tidal partial pressure of carbon dioxide between the groups
Time Frame
30 and 60 min after anesthetic induction
Title
difference of partial pressure of arterial carbon dioxide between the groups
Time Frame
60 min after anesthetic induction on average
Title
heart rate change from baseline value
Time Frame
30 and 60 min after anesthetic induction
Title
non-invasive blood pressure change from baseline value
Time Frame
30 and 60 min after anesthetic induction
Secondary Outcome Measure Information:
Title
movement at topical anesthetic injection
Description
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)
Time Frame
20 min after anesthetic induction on average
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kazuhiko Okuyama, MD
Organizational Affiliation
Ibaraki Children's Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Yuki Takeda, MD
Organizational Affiliation
Ibaraki Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ibaraki Children's Hospital
City
Mito
State/Province
Ibaraki
ZIP/Postal Code
311-4145
Country
Japan

12. IPD Sharing Statement

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Does Ketamine Attenuate Depression of Respiratory and Cardiac Functions

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