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

NCT03631875 | Completed Phase 4

• 1 other identifier: Ketco1
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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

Conditions

Anesthesia Intubation Complication

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• hemodynamic conditions

  HOURS 1

• heart rate

  HOURS 1

Study Arms (2)

P (propofol),

PLACEBO COMPARATOR

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

PK (propofol-ketamine)

ACTIVE COMPARATOR

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

Interventions

Ketamine DRUG

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

P (propofol),; PK (propofol-ketamine)

Eligibility Criteria

• Age: 1 Year - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• surgery complication
• upper air way complications

Sponsors & Collaborators

• University Hospital, Mahdia: lead

Study Sites (1)

Mahdia University Hospital

Mahdia, 5100, Tunisia

Location

MeSH Terms

Interventions

Ketamine

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• ali majdoub, professor

  Ministery of Health

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: head of anesthesia departement

Model Details: 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.

Study Record Dates

• First Submitted: July 2, 2018
• First Posted: August 15, 2018
• Study Start: May 1, 2019
• Primary Completion: November 30, 2019
• Study Completion: November 30, 2019
• Last Updated: April 16, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)