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Laryngeal Mask Insertion Conditions And Hemodynamic Effects

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ClinicalTrials.gov Identifier: NCT03257800
Recruitment Status : Completed
First Posted : August 22, 2017
Last Update Posted : August 22, 2017
Sponsor:
Information provided by (Responsible Party):
Leila mansali stambouli, University of Monastir

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.

Condition or disease Intervention/treatment Phase
Laryngeal Masks Drug: Ketamine Drug: placebo Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized, controlled and double blind assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: Laryngeal Mask Insertion Conditions And Hemodynamic Effects After Propofol And Ketamine-Propofol Co-induction
Actual Study Start Date : June 1, 2013
Actual Primary Completion Date : December 30, 2013
Actual Study Completion Date : December 31, 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: ketamine-propofol group

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.

Drug: Ketamine
Ketamine 0,5mg.kg-¹was injected intravenously one minute prior propofol 3mg.kg-¹ and one minute before LMA insertion in Ketamine-propofol group
Other Name: sevoflurane, nitrous oxide (N2O)

Placebo Comparator: propofol group

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.

Drug: placebo
The control group which received intravenously the same volume with normal saline one minute prior propofol 3mg.kg-¹ and 1 min before LMA insertion in propofol group
Other Name: sevoflurane, N2O




Primary Outcome Measures :
  1. LMA insertion conditions [ Time Frame: 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 :
  1. hemodynamic effects [ Time Frame: 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)


Other Outcome Measures:
  1. delirium [ Time Frame: from awake until 30 min after emergence ]
    Emergence delirium was assessed by the Pediatric Anesthesia Emergence Delirium Scale (PAED) and was defined as a PAED score >10



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Ages Eligible for Study:   1 Year to 8 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03257800


Locations
Tunisia
University Hospital of Fattouma Bourguiba
Monastir, Tunisia, 5000
Sponsors and Collaborators
Leila mansali stambouli
Investigators
Principal Investigator: leila Mansali Stambouli, MD PhD university Hospital of Fattouma Bourguiba, Monastir, TUNISIA

Publications:
Responsible Party: Leila mansali stambouli, Principal Investigator and Clinical Professor, University of Monastir
ClinicalTrials.gov Identifier: NCT03257800     History of Changes
Other Study ID Numbers: 0925-0586
First Posted: August 22, 2017    Key Record Dates
Last Update Posted: August 22, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Leila mansali stambouli, University of Monastir:
ketamine
Propofol
laryngeal masks
anesthesia
child

Additional relevant MeSH terms:
Propofol
Ketamine
Sevoflurane
Nitrous Oxide
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Dissociative
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Anesthetics, Inhalation
Analgesics, Non-Narcotic