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

U

University Hospital, Mahdia

Status and phase

Completed
Phase 4

Conditions

Anesthesia Intubation Complication

Treatments

Drug: Ketamine

Study type

Interventional

Funder types

Other

Identifiers

NCT03631875
Ketco1

Details and patient eligibility

About

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

Full 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

Enrollment

120 patients

Sex

All

Ages

1 to 8 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

  • surgery complication
  • upper air way complications

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

120 participants in 2 patient groups, including a placebo group

P (propofol),
Placebo Comparator group
Description:
normal saline is injected 01 min before induction with propofol 3 mg/kg. After 60 seconds, an experimented anesthesiologist evaluated the LM conditions insertion.
Treatment:
Drug: Ketamine
PK (propofol-ketamine)
Active Comparator group
Description:
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.
Treatment:
Drug: Ketamine

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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