Laryngeal Mask Insertion Conditions And Hemodynamic Effects
Brief Summary
Study Design
Study type: | Interventional |
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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 | |
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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
Location
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 |
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Minimum Age: | 1 |
Maximum Age: | 8 |
More Details
NCT Number: | NCT03257800 |
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Other IDs: | 0925-0586 |
Study URL: | https://ClinicalTrials.gov/show/NCT03257800 |