Does Ketamine Attenuate Depression of Respiratory and Cardiac Functions

NCT01501786 | Completed

• 1 other identifier: ketamine in sedation
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Congenital Heart Disease; Sedated for Cardiac Catheterization

Keywords

children; sedation; propofol; ketamine

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• movement at topical anesthetic injection

  20 min after anesthetic induction on average

• 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

Study Arms (3)

control

SHAM COMPARATOR

propofol and saline are administered

Drug: control

Ket10

EXPERIMENTAL

ketamine is co-administered with propofol

Drug: Ket10

Ket20

EXPERIMENTAL

ketamine is co-administered with porpofol

Drug: Ket20

Interventions

control DRUG

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

Also known as: saline with propofol

control

Ket10 DRUG

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

Also known as: ketamine 10 γ

Ket10

Ket20 DRUG

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

Also known as: ketamine 20 γ

Ket20

Eligibility Criteria

• Age: 6 Months - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• kg-25kg (6mo-10yrs) children who undergo cardiac catheterization

You may not qualify if:

• patients who have neurological disease,
• endocrinological disease,
• airway anomaly, who require positive pressure ventilation

Sponsors & Collaborators

• Ibaraki Children's Hospital: lead

Study Sites (1)

Ibaraki Children's Hospital

Mito, Ibaraki, 311-4145, Japan

Location

MeSH Terms

Conditions

Heart Defects, Congenital

Interventions

Sodium Chloride; Propofol

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Kazuhiko Okuyama, MD

  Ibaraki Children's Hospital

  STUDY CHAIR

• Yuki Takeda, MD

  Ibaraki Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Anesthesiology department

Study Record Dates

• First Submitted: December 10, 2011
• First Posted: December 29, 2011
• Study Start: January 1, 2012
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: July 30, 2013

Record last verified: 2013-07

Locations

JP (1)