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Completed

NCT Number: NCT03257800

Laryngeal Mask Insertion Conditions And Hemodynamic Effects

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.

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Key information

Conditions

Age range

1 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital of Fattouma Bourguiba

Monastir, 5000, Tunisia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ketamine

Drug

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 names: sevoflurane, nitrous oxide (N2O)

Placebo

Drug

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 names: sevoflurane, N2O

Primary outcomes

  1. 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

Secondary outcomes

  1. 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)

Other outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Leila mansali stambouli

Other

Registry information

Official study title

Laryngeal Mask Insertion Conditions And Hemodynamic Effects After Propofol And Ketamine-Propofol Co-induction

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Aug 22, 2017
Registry last updated
Aug 22, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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