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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03631875
Other study ID # Ketco1
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date May 1, 2019
Est. completion date November 30, 2019

Study information

Verified date April 2020
Source University Hospital, Mahdia
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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


Recruitment information / eligibility

Status Completed
Enrollment 120
Est. completion date November 30, 2019
Est. primary completion date November 30, 2019
Accepts healthy volunteers No
Gender All
Age group 1 Year to 8 Years
Eligibility Inclusion Criteria:

- American Society of Anesthesiologist (ASA) physical status I and II

- unpremedicated

- ambulatory surgery

Exclusion Criteria:

- surgery complication

- upper air way complications

Study Design


Related Conditions & MeSH terms

  • Anesthesia Intubation Complication

Intervention

Drug:
Ketamine
use a low dose 0.5 mg/kg of ketamine in coinduction with propofol in children induction anesthesia

Locations

Country Name City State
Tunisia Mahdia University Hospital Mahdia

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Mahdia

Country where clinical trial is conducted

Tunisia, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 MINUTE 1
Secondary hemodynamic conditions systolic blood pressure HOURS 1
Secondary heart rate cardiac frequence HOURS 1
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