Laryngeal Mask Insertion Conditions And Hemodynamic Effects

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.

Intervention / Treatment

  • Drug: Ketamine
  • Drug: Placebo

Condition or Disease

  • Laryngeal Masks

Phase

Study Design

Study type: Interventional
Status: Completed
Study results: No Results Available
Age: 1 Year to 8 Years   (Child)
Enrollment: 120 ()
Funded by: Other

Masking

Clinical Trial Dates

Start date: Jun 01, 2013
Primary Completion: Dec 30, 2013
Completion Date: Dec 31, 2013
Study First Posted: Aug 22, 2017
Results First Posted: Aug 31, 2020
Last Updated: Aug 22, 2017

Sponsors / Collaborators

Lead Sponsor: N/A
Responsible Party: N/A

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.

Eligibility Criteria

Sex: All
Minimum Age: 1
Maximum Age: 8

More Details

NCT Number: NCT03257800
Other IDs: 0925-0586
Study URL: https://ClinicalTrials.gov/show/NCT03257800
Last updated: Mar 18, 2021