ClinicalTrials.Veeva

Menu

Laryngeal Mask Insertion Conditions And Hemodynamic Effects

L

Leila mansali stambouli

Status

Completed

Conditions

Laryngeal Masks

Treatments

Drug: placebo
Drug: Ketamine

Study type

Interventional

Funder types

Other

Identifiers

NCT03257800
0925-0586

Details and patient eligibility

About

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.

Full 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.

Enrollment

120 patients

Sex

All

Ages

1 to 8 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

120 participants in 2 patient groups, including a placebo group

ketamine-propofol group
Active Comparator group
Description:
Ketamine (50mg/ml) at 0.5 mg.kg-1 was injected intravenously 1min prior 3 mgkg-1 of propofol and 1 min before LMA insertion in Ketamine-propofol group. sevoflurane 6-7% was used on vaporizer setting with 50% nitrous oxide in oxgen prior intravenous anesthesia. The loss of eyelash reflex was considered as the desired end point for induction.
Treatment:
Drug: Ketamine
propofol group
Placebo Comparator group
Description:
0,9% saline solution ( Placebo ) at the same volume as ketamine (50mg/ml) was injected intravenously 1min prior propofol 3 mg.kg-1 and 1 min before LMA insertion in propofol group. sevoflurane 6-7% was used on vaporizer setting with 50% nitrous oxide in oxgen prior intravenous anesthesia. The loss of eyelash reflex was considered as the desired end point for induction.
Treatment:
Drug: placebo

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems