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Co-induction Ketamine-propofol: Effects on Laryngeal Mask Airway Insertion Conditions in Children

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ClinicalTrials.gov Identifier: NCT03631875
Recruitment Status : Completed
First Posted : August 15, 2018
Last Update Posted : April 16, 2020
Sponsor:
Information provided by (Responsible Party):
Majdoub Ali MD, University Hospital, Mahdia

Tracking Information
First Submitted Date  ICMJE July 2, 2018
First Posted Date  ICMJE August 15, 2018
Last Update Posted Date April 16, 2020
Actual Study Start Date  ICMJE May 1, 2019
Actual Primary Completion Date November 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 22, 2019)
laryngeal masque conditions insertion [ Time Frame: MINUTE 1 ]
When the jaw was relaxed, and deglutition and cough reflex and member movement were absent, the conditions were considered acceptable.the laryngeal masque was inserted
Original Primary Outcome Measures  ICMJE
 (submitted: August 11, 2018)
laryngale masque conditions insertion [ Time Frame: MINUTE 1 ]
When the jaw was relaxed, and deglutition and cough reflex and member movement were absent, the conditions were considered acceptable.the laryngal masque was inserted
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 22, 2019)
  • hemodynamic conditions [ Time Frame: HOURS 1 ]
    systolic blood pressure
  • heart rate [ Time Frame: HOURS 1 ]
    cardiac frequence
Original Secondary Outcome Measures  ICMJE
 (submitted: August 11, 2018)
  • hemodynamic conditions [ Time Frame: HOURS 1 ]
    systolic bload pressure
  • heart rate [ Time Frame: HOURS 1 ]
    cardiac frequence
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Co-induction Ketamine-propofol: Effects on Laryngeal Mask Airway Insertion Conditions in Children
Official Title  ICMJE Co-induction Ketamine-propofol: the Effects on Laryngeal Mask Airway Insertion Conditions and Resulting Hemodynamic Changes in Children
Brief Summary

Background: Large doses of propofol needed for induction and laryngeal mask (LM) insertion in children may be associated with hemodynamic sides effects. Co-induction with low doses of ketamine 0.5 mg/ kg has the advantage of reducing dose and therefore maintaining hemodynamic stability.

Aim: To examine the effect of co-induction on LM insertion, hemodynamics and recovery in children

Detailed Description A prospective, randomized, double-blind, controlled study was conducted including120 ASA physical status I ⁄ II unpremedicated children, aged 1-8 years. Inhalatory induction with sevoflurane at 7% to insert an intravenous canula was first used then decreased to 2%. Normal saline or ketamine (0.5 mg/kg) were administered in groups P (propofol), PK (propofol-ketamine) respectively, 1 min prior to the administration of the induction dose of propofol. Propofol 3mg/kg was used for induction in the 2 groups, LM inserted 60 s later and insertion conditions assessed. Heart rate and blood pressure were recorded immediately after propofol bolus, then after LM insertion, at the 3rd ,5th and 10th minutes later. Recovery was assessed using Steward's Score
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
After inhalatory induction with sevoflurane7%until abolition of the eye lash reflex, an intravenous canula was inserted in the dorsum of the hand. The sevoflurane concentration was then decreased to 2% in 100% O2.A nurse not involved in the study prepared two syringes with ketamine or normal saline, and administrated it according randomization , one minute before induction with propofol. The administration of propofol was realized on 60 seconds. An experimented anesthesiologist evaluated the LM conditions insertion. When the jaw was relaxed, and deglutition and cough reflex and member movement were absent, the conditions were considered acceptable. The LM was then inserted. For analgesia,we proceeded by a locoregional bloc adapted to the surgery. We recorded systolic and diastolic blood pressure, HR and SpO2 at the induction time at LM insertion and at the 3rd,5th and10th min.
Masking: Single (Outcomes Assessor)
Masking Description:
A nurse not involved in the study prepared two syringes with ketamine or normal saline, and administrated it according randomization (by computer generated random numbers) one minute before induction with propofol
Primary Purpose: Diagnostic
Condition  ICMJE Anesthesia Intubation Complication
Intervention  ICMJE Drug: Ketamine
use a low dose 0.5 mg/kg of ketamine in coinduction with propofol in children induction anesthesia
Other Name: co-induction ketamine propofol
Study Arms  ICMJE
  • Placebo Comparator: P (propofol),
    normal saline is injected 01 min before induction with propofol 3 mg/kg. After 60 seconds, an experimented anesthesiologist evaluated the LM conditions insertion.
    Intervention: Drug: Ketamine
  • Active Comparator: PK (propofol-ketamine)
    we inject 0.5 mg/kg of ketamine 01 min before induction with 03 mg/kg of propofol .Sixty seconds after, an experimented anesthesiologist evaluated the LM conditions insertion.
    Intervention: Drug: Ketamine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 11, 2018)
120
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 30, 2019
Actual Primary Completion Date November 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • American Society of Anesthesiologist (ASA) physical status I and II
  • unpremedicated
  • ambulatory surgery

Exclusion Criteria:

  • surgery complication
  • upper air way complications
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 1 Year to 8 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Tunisia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03631875
Other Study ID Numbers  ICMJE Ketco1
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Majdoub Ali MD, University Hospital, Mahdia
Study Sponsor  ICMJE University Hospital, Mahdia
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: ali majdoub, professor Ministery of Health
PRS Account University Hospital, Mahdia
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP