Clinical trial NCT03631875: Co-induction Ketamine-propofol: Effects on Laryngeal Mask Airway Insertion Conditions in Children
Official title: Co-induction Ketamine-propofol: the Effects on Laryngeal Mask Airway Insertion Conditions and Resulting Hemodynamic Changes in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Anesthesia Intubation Complication
Lead sponsor: University Hospital, Mahdia
Sponsor class: OTHER
First posted: 2018-08-15
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: After inhalatory induction with sevoflurane7%until abolition of the eye lash reflex, an intravenous canula was inserted in the dorsum of the hand. The sevoflurane concentration was then decreased to 2% in 100% O2.A nurse not involved in the study prepared two syringes with ketamine or normal saline, and administrated it according randomization , one minute before induction with propofol. The administration of propofol was realized on 60 seconds. An experimented anesthesiologist evaluated the LM conditions insertion. When the jaw was relaxed, and deglutition and cough reflex and member movement were absent, the conditions were considered acceptable. The LM was then inserted. For analgesia,we proceeded by a locoregional bloc adapted to the surgery. We recorded systolic and diastolic blood pressure, HR and SpO2 at the induction time at LM insertion and at the 3rd,5th and10th min.
Primary purpose: DIAGNOSTIC

Brief summary: Background: Large doses of propofol needed for induction and laryngeal mask (LM) insertion in children may be associated with hemodynamic sides effects. Co-induction with low doses of ketamine 0.5 mg/ kg has the advantage of reducing dose and therefore maintaining hemodynamic stability.

Aim: To examine the effect of co-induction on LM insertion, hemodynamics and recovery in children

Detailed description: A prospective, randomized, double-blind, controlled study was conducted including120 ASA physical status I ⁄ II unpremedicated children, aged 1-8 years. Inhalatory induction with sevoflurane at 7% to insert an intravenous canula was first used then decreased to 2%. Normal saline or ketamine (0.5 mg/kg) were administered in groups P (propofol), PK (propofol-ketamine) respectively, 1 min prior to the administration of the induction dose of propofol. Propofol 3mg/kg was used for induction in the 2 groups, LM inserted 60 s later and insertion conditions assessed. Heart rate and blood pressure were recorded immediately after propofol bolus, then after LM insertion, at the 3rd ,5th and 10th minutes later. Recovery was assessed using Steward's Score

Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologist (ASA) physical status I and II
* unpremedicated
* ambulatory surgery

Exclusion Criteria:

* surgery complication
* upper air way complications

Primary outcomes:
measure: laryngeal masque conditions insertion
timeFrame: MINUTE 1
Secondary outcomes:
measure: hemodynamic conditions
timeFrame: HOURS 1
measure: heart rate
timeFrame: HOURS 1
Other outcomes:
Locations:
city: Mahdia
country: Tunisia
facility: Mahdia University Hospital
Study officials:
affiliation: Ministery of Health
name: ali majdoub, professor
role: STUDY_DIRECTOR
References: