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

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ClinicalTrials.gov Identifier: NCT03631875
Recruitment Status : Recruiting
First Posted : August 15, 2018
Last Update Posted : June 25, 2019
Sponsor:
Information provided by (Responsible Party):
Majdoub Ali MD, University Hospital, Mahdia

Brief 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


Condition or disease Intervention/treatment Phase
Anesthesia Intubation Complication Drug: Ketamine Phase 4

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: After inhalatory induction with sevoflurane7%until abolition of the eye lash reflex, an intravenous canula was inserted in the dorsum of the hand. The sevoflurane concentration was then decreased to 2% in 100% O2.A nurse not involved in the study prepared two syringes with ketamine or normal saline, and administrated it according randomization , one minute before induction with propofol. The administration of propofol was realized on 60 seconds. An experimented anesthesiologist evaluated the LM conditions insertion. When the jaw was relaxed, and deglutition and cough reflex and member movement were absent, the conditions were considered acceptable. The LM was then inserted. For analgesia,we proceeded by a locoregional bloc adapted to the surgery. We recorded systolic and diastolic blood pressure, HR and SpO2 at the induction time at LM insertion and at the 3rd,5th and10th min.
Masking: Single (Outcomes Assessor)
Masking Description: A nurse not involved in the study prepared two syringes with ketamine or normal saline, and administrated it according randomization (by computer generated random numbers) one minute before induction with propofol
Primary Purpose: Diagnostic
Official Title: Co-induction Ketamine-propofol: the Effects on Laryngeal Mask Airway Insertion Conditions and Resulting Hemodynamic Changes in Children
Actual Study Start Date : May 1, 2019
Estimated Primary Completion Date : November 30, 2019
Estimated Study Completion Date : November 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: P (propofol),
normal saline is injected 01 min before induction with propofol 3 mg/kg. After 60 seconds, an experimented anesthesiologist evaluated the LM conditions insertion.
Drug: Ketamine
use a low dose 0.5 mg/kg of ketamine in coinduction with propofol in children induction anesthesia
Other Name: co-induction ketamine propofol

Active Comparator: PK (propofol-ketamine)
we inject 0.5 mg/kg of ketamine 01 min before induction with 03 mg/kg of propofol .Sixty seconds after, an experimented anesthesiologist evaluated the LM conditions insertion.
Drug: Ketamine
use a low dose 0.5 mg/kg of ketamine in coinduction with propofol in children induction anesthesia
Other Name: co-induction ketamine propofol




Primary Outcome Measures :
  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 Outcome Measures :
  1. hemodynamic conditions [ Time Frame: HOURS 1 ]
    systolic blood pressure

  2. heart rate [ Time Frame: HOURS 1 ]
    cardiac frequence



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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:

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

Exclusion Criteria:

  • surgery complication
  • upper air way complications

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): NCT03631875


Contacts
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Contact: Ali majdoub, professor 0021650030022 majdlee2013@gmail.com

Locations
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Tunisia
Mahdia University Hospital Recruiting
Mahdia, Tunisia, 5100
Contact: Majdoub Ali, MD    00216 50030022    majdlee2013@gmail.com   
Contact: meksi yassine, MD    0021699229906    meksiyassine@gmail.com   
Principal Investigator: majdoub ali, MD         
Principal Investigator: ouaz mouna, MD         
Sponsors and Collaborators
University Hospital, Mahdia
Investigators
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Study Director: ali majdoub, professor Ministery of Health

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Responsible Party: Majdoub Ali MD, head of anesthesia departement, University Hospital, Mahdia
ClinicalTrials.gov Identifier: NCT03631875     History of Changes
Other Study ID Numbers: Ketco1
First Posted: August 15, 2018    Key Record Dates
Last Update Posted: June 25, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Additional relevant MeSH terms:
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Ketamine
Propofol
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