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Laryngeal Mask Insertion Conditions And Hemodynamic Effects

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ClinicalTrials.gov Identifier: NCT03257800
Recruitment Status : Completed
First Posted : August 22, 2017
Last Update Posted : August 22, 2017
Sponsor:
Information provided by (Responsible Party):
Leila mansali stambouli, University of Monastir

Tracking Information
First Submitted Date  ICMJE July 16, 2017
First Posted Date  ICMJE August 22, 2017
Last Update Posted Date August 22, 2017
Actual Study Start Date  ICMJE June 1, 2013
Actual Primary Completion Date December 30, 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 18, 2017)
LMA insertion conditions [ Time Frame: 2 minutes ]
satisfactory conditions of LMA insertion are defined as when 4 criteria were acceptable: jaw relaxation, no coughing or swallowing and no limb movement. unsatisfactory conditions of LMA insertion is defined as when there's at least one unacceptable of these criteria
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: August 18, 2017)
hemodynamic effects [ Time Frame: from Baseline period until 10 minutes after LMA insertion ]
mean blood pressure (MAP) in mmHg . Heart Rate (HR) in beats per minute (time frame: from baseline to LMA insertion)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: August 18, 2017)
delirium [ Time Frame: from awake until 30 min after emergence ]
Emergence delirium was assessed by the Pediatric Anesthesia Emergence Delirium Scale (PAED) and was defined as a PAED score >10
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Laryngeal Mask Insertion Conditions And Hemodynamic Effects
Official Title  ICMJE Laryngeal Mask Insertion Conditions And Hemodynamic Effects After Propofol And Ketamine-Propofol Co-induction
Brief Summary This interventional double-blind, randomized trial has included120 children of American Society of Anesthesiologist (ASA) physical status I or II aged between 1and 8 years of either sex, scheduled for outpatient minor surgery under general anesthesia.This study examined whether co-induction with ketamine-propofol enhance laryngeal mask airway (LMA) insertion conditions and preserve hemodynamic state in patients.
Detailed Description

This study aims to compare two anesthesia protocols: propofol induction with or without a prior injection of ketamine, in term of LMA insertion conditions(favorable= satisfactory or unfavorable= unsatisfactory ) and hemodynamic effects (decrease of 20 % from baseline of blood pressure and heart rate).

The conditions of LMA insertion have been assessed in each study group by an experimented anesthesiologist, who was unaware of the treatment group assignment. Conditions were considered satisfactory, if the 4 following criteria were acceptable: the jaw was relaxed, there was no coughing, swallowing and no limb movement, and then the LMA was inserted. When the investigators save at least one unacceptable of these criteria, conditions were considered to be unsatisfactory and thereafter anesthesia was deepened with supplemental dose of propofol 1mg.kg-¹ and 1 minute later a reinsertion was attempted. The total number of attempts at LMA insertion was recorded. Children trachea was intubated after 3 failed attempts of LMA insertion, and then patient was excluded.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Randomized, controlled and double blind assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Other
Condition  ICMJE Laryngeal Masks
Intervention  ICMJE
  • Drug: Ketamine
    Ketamine 0,5mg.kg-¹was injected intravenously one minute prior propofol 3mg.kg-¹ and one minute before LMA insertion in Ketamine-propofol group
    Other Name: sevoflurane, nitrous oxide (N2O)
  • Drug: placebo
    The control group which received intravenously the same volume with normal saline one minute prior propofol 3mg.kg-¹ and 1 min before LMA insertion in propofol group
    Other Name: sevoflurane, N2O
Study Arms  ICMJE
  • Active Comparator: ketamine-propofol group

    Ketamine (50mg/ml) at 0.5 mg.kg-1 was injected intravenously 1min prior 3 mgkg-1 of propofol and 1 min before LMA insertion in Ketamine-propofol group.

    sevoflurane 6-7% was used on vaporizer setting with 50% nitrous oxide in oxgen prior intravenous anesthesia. The loss of eyelash reflex was considered as the desired end point for induction.

    Intervention: Drug: Ketamine
  • Placebo Comparator: propofol group

    0,9% saline solution ( Placebo ) at the same volume as ketamine (50mg/ml) was injected intravenously 1min prior propofol 3 mg.kg-1 and 1 min before LMA insertion in propofol group.

    sevoflurane 6-7% was used on vaporizer setting with 50% nitrous oxide in oxgen prior intravenous anesthesia. The loss of eyelash reflex was considered as the desired end point for induction.

    Intervention: Drug: placebo
Publications *

*   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 18, 2017)
120
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 31, 2013
Actual Primary Completion Date December 30, 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • ASA physical status I or II who were scheduled to minor elective ambulatory surgery (e.g. inguinal hernia, undescended testes, umbilical hernia) performed by experienced surgeon under general anesthesia.

Exclusion Criteria:

  • patients with full stomach
  • A history of gastric reflux
  • A history of convulsions, cardiovascular or neuromuscular disease
  • Allergies to the study drugs
  • obese children
  • suspected difficult airway and hyper-reactive airway disease
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 NCT03257800
Other Study ID Numbers  ICMJE 0925-0586
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 Leila mansali stambouli, University of Monastir
Study Sponsor  ICMJE Leila mansali stambouli
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: leila Mansali Stambouli, MD PhD university Hospital of Fattouma Bourguiba, Monastir, TUNISIA
PRS Account University of Monastir
Verification Date August 2017

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