Laryngeal Mask Insertion Conditions And Hemodynamic Effects

Not Applicable

Completed

• Conditions: Laryngeal Masks
• Interventions: Drug: placebo; Drug: Ketamine

• Registration Number: NCT03257800
• Lead Sponsor: Leila mansali stambouli

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2013-06-01
• Primary Completion: 2013-12-30
• Study Completion: 2013-12-31
• Study First Submitted: 2017-07-16
• Status Verified: 2017-08
• Study First Submitted QC: 2017-08-18
• Last Update Submitted: 2017-08-18
• Study First Posted: 2017-08-22
• Last Update Posted: 2017-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
propofol group	placebo	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.
ketamine-propofol group	Ketamine	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.

Primary Outcome Measures

Name	Time	Method
LMA insertion conditions	2 minutes	satisfactory conditions of LMA insertion are defined as when 4 criteria were acceptable: jaw relaxation, no coughing or swallowing and no limb movement.; unsatisfactory conditions of LMA insertion is defined as when there's at least one unacceptable of these criteria

Secondary Outcome Measures

Name	Time	Method
hemodynamic effects	from Baseline period until 10 minutes after LMA insertion	mean blood pressure (MAP) in mmHg . Heart Rate (HR) in beats per minute (time frame: from baseline to LMA insertion)

Trial Locations

Locations (1)

University Hospital of Fattouma Bourguiba; 🇹🇳 Monastir, Tunisia