A Phase 4 interventional study of Ketamine in Anesthesia Intubation Complication, sponsored by University Hospital, Mahdia. Completed at 1 site in Tunisia. Open to participants aged 1 Year to 8 Years. Per ClinicalTrials.gov, last updated 2020-04-16.
Sponsored by University Hospital, Mahdia · Phase 4, Interventional, and Diagnostic
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
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
University Hospital, Mahdia is the lead sponsor of 10 studies on the registry; none are open to participants now.
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The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
Also known as: co-induction ketamine propofol
laryngeal masque conditions insertion
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
Time frame: MINUTE 1
hemodynamic conditions
systolic blood pressure
Time frame: HOURS 1
heart rate
cardiac frequence
Time frame: HOURS 1
Plan to share: No
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This study is completed, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Ketamine
University Hospital, Mahdia