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

Anesthesia Intubation Complication Clinical Trial

Official title:

Co-induction Ketamine-propofol: the Effects on Laryngeal Mask Airway Insertion Conditions and Resulting Hemodynamic Changes in Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03631875
• Other study ID #: Ketco1
• Status: Completed
• Phase: Phase 4
• 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
• 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

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