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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03631875
Enrollment
120
Registered
2018-08-15
Start date
2019-05-01
Completion date
2019-11-30
Last updated
2020-04-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia Intubation Complication

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

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

Interventions

DRUGKetamine

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

Sponsors

University Hospital, Mahdia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
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

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.

Eligibility

Sex/Gender
ALL
Age
1 Years to 8 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* surgery complication * upper air way complications

Design outcomes

Primary

MeasureTime frameDescription
laryngeal masque conditions insertionMINUTE 1When 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

MeasureTime frameDescription
hemodynamic conditionsHOURS 1systolic blood pressure
heart rateHOURS 1cardiac frequence

Countries

Tunisia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026