Clinical Trials Directory

Trials / Completed

CompletedNCT03631875

Co-induction Ketamine-propofol: Effects on Laryngeal Mask Airway Insertion Conditions in Children

Co-induction Ketamine-propofol: the Effects on Laryngeal Mask Airway Insertion Conditions and Resulting Hemodynamic Changes in Children

Status
Completed
Phase
Phase 4
Study type
Interventional
Enrollment
120 (actual)
Sponsor
University Hospital, Mahdia · Academic / Other
Sex
All
Age
1 Year – 8 Years
Healthy volunteers
Not accepted

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

Conditions

Interventions

TypeNameDescription
DRUGKetamineuse a low dose 0.5 mg/kg of ketamine in coinduction with propofol in children induction anesthesia

Timeline

Start date
2019-05-01
Primary completion
2019-11-30
Completion
2019-11-30
First posted
2018-08-15
Last updated
2020-04-16

Locations

1 site across 1 country: Tunisia

Source: ClinicalTrials.gov record NCT03631875. Inclusion in this directory is not an endorsement.