University Hospital of Fattouma Bourguiba
Monastir, 5000, Tunisia
NCT Number: NCT03257800
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.
Looking for future studies?
Notify Me1 year–8 year
All sexes
Interventional
Not applicable
Monastir, 5000, Tunisia
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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)
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
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
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)
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
Leila mansali stambouli
Other
Laryngeal Mask Insertion Conditions And Hemodynamic Effects After Propofol And Ketamine-Propofol Co-induction
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.
Published trials that share one or more normalized conditions with this study.
NCT06617403
Anesthesia, General, Laryngeal Masks
Ulm, Baden-Wurttemberg, Germany
View Trial DetailsNCT03931122
Child, Laryngeal Masks
Karachi, Sindh, Pakistan
View Trial DetailsNCT03028896
Laryngeal Masks
View Trial DetailsNCT04206592
Airway Management, Laryngeal Masks
Barcelona, Spain
View Trial Details