Skip to main content
OpenTrials
Completed

NCT Number: NCT03631875

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Anesthesia Intubation Complication

Age range

1 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Mahdia University Hospital

Mahdia, 5100, Tunisia

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • surgery complication
  • upper air way complications

Treatment and study plan

ketamine

Drug

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

Other names: co-induction ketamine propofol

Primary outcomes

  1. laryngeal masque conditions insertion

    Time frame: MINUTE 1

    When the jaw was relaxed, and deglutition and cough reflex and member movement were absent, the conditions were considered acceptable.the laryngeal masque was inserted

Secondary outcomes

  1. hemodynamic conditions

    Time frame: HOURS 1

    systolic blood pressure

  2. heart rate

    Time frame: HOURS 1

    cardiac frequence

Sponsors and collaborators

Lead sponsor

University Hospital, Mahdia

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Aug 15, 2018
Registry last updated
Apr 16, 2020

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.