Clinical trial NCT03257800: Laryngeal Mask Insertion Conditions And Hemodynamic Effects
Official title: Laryngeal Mask Insertion Conditions And Hemodynamic Effects After Propofol And Ketamine-Propofol Co-induction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Laryngeal Masks
Keywords: ketamine
Propofol
laryngeal masks
anesthesia
child
Lead sponsor: University of Monastir
Sponsor class: OTHER
First posted: 2017-08-22
Enrollment: 120
Sex: ALL
Minimum age (years): 1
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, controlled and double blind assignment
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: LMA insertion conditions
timeFrame: 2 minutes
Secondary outcomes:
measure: hemodynamic effects
timeFrame: from Baseline period until 10 minutes after LMA insertion
Other outcomes:
measure: delirium
timeFrame: from awake until 30 min after emergence
Locations:
city: Monastir
country: Tunisia
facility: University Hospital of Fattouma Bourguiba
Study officials:
affiliation: university Hospital of Fattouma Bourguiba, Monastir, TUNISIA
name: leila Mansali Stambouli, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Goel S, Bhardwaj N, Jain K. Efficacy of ketamine and midazolam as co-induction agents with propofol for laryngeal mask insertion in children. Paediatr Anaesth. 2008 Jul;18(7):628-34. doi: 10.1111/j.1460-9592.2008.02563.x. Epub 2008 May 8.
citation: Singh R, Arora M, Vajifdar H. Randomized double-blind comparison of ketamine-propofol and fentanyl-propofol for the insertion of laryngeal mask airway in children. J Anaesthesiol Clin Pharmacol. 2011 Jan;27(1):91-6.