Laryngeal Mask Insertion Conditions And Hemodynamic Effects

NCT03257800 | Completed

• 1 other identifier: 0925-0586
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

This interventional double-blind, randomized trial has included120 children of American Society of Anesthesiologist (ASA) physical status I or II aged between 1and 8 years of either sex, scheduled for outpatient minor surgery under general anesthesia.This study examined whether co-induction with ketamine-propofol enhance laryngeal mask airway (LMA) insertion conditions and preserve hemodynamic state in patients.

Conditions

Laryngeal Masks

Keywords

ketamine; Propofol; laryngeal masks; anesthesia; child

Outcome Measures

Primary Outcomes (1)

• LMA insertion conditions

  satisfactory conditions of LMA insertion are defined as when 4 criteria were acceptable: jaw relaxation, no coughing or swallowing and no limb movement. unsatisfactory conditions of LMA insertion is defined as when there's at least one unacceptable of these criteria

  2 minutes

Secondary Outcomes (1)

• hemodynamic effects

  from Baseline period until 10 minutes after LMA insertion

Other Outcomes (1)

• delirium

  from awake until 30 min after emergence

Study Arms (2)

ketamine-propofol group

ACTIVE COMPARATOR

Ketamine (50mg/ml) at 0.5 mg.kg-1 was injected intravenously 1min prior 3 mgkg-1 of propofol and 1 min before LMA insertion in Ketamine-propofol group. sevoflurane 6-7% was used on vaporizer setting with 50% nitrous oxide in oxgen prior intravenous anesthesia. The loss of eyelash reflex was considered as the desired end point for induction.

Drug: Ketamine

propofol group

PLACEBO COMPARATOR

0,9% saline solution ( Placebo ) at the same volume as ketamine (50mg/ml) was injected intravenously 1min prior propofol 3 mg.kg-1 and 1 min before LMA insertion in propofol group. sevoflurane 6-7% was used on vaporizer setting with 50% nitrous oxide in oxgen prior intravenous anesthesia. The loss of eyelash reflex was considered as the desired end point for induction.

Drug: placebo

Interventions

Ketamine DRUG

Ketamine 0,5mg.kg-¹was injected intravenously one minute prior propofol 3mg.kg-¹ and one minute before LMA insertion in Ketamine-propofol group

Also known as: sevoflurane, nitrous oxide (N2O)

ketamine-propofol group

placebo DRUG

The control group which received intravenously the same volume with normal saline one minute prior propofol 3mg.kg-¹ and 1 min before LMA insertion in propofol group

Also known as: sevoflurane, N2O

propofol group

Eligibility Criteria

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

You may qualify if:

• ASA physical status I or II who were scheduled to minor elective ambulatory surgery (e.g. inguinal hernia, undescended testes, umbilical hernia) performed by experienced surgeon under general anesthesia.

You may not qualify if:

• patients with full stomach
• A history of gastric reflux
• A history of convulsions, cardiovascular or neuromuscular disease
• Allergies to the study drugs
• obese children
• suspected difficult airway and hyper-reactive airway disease

Sponsors & Collaborators

• Leila mansali stambouli: lead

Study Sites (1)

University Hospital of Fattouma Bourguiba

Monastir, 5000, Tunisia

Location

Related Publications (2)

• Goel S, Bhardwaj N, Jain K. Efficacy of ketamine and midazolam as co-induction agents with propofol for laryngeal mask insertion in children. Paediatr Anaesth. 2008 Jul;18(7):628-34. doi: 10.1111/j.1460-9592.2008.02563.x. Epub 2008 May 8.

  PMID: 18482245 BACKGROUND

• Singh R, Arora M, Vajifdar H. Randomized double-blind comparison of ketamine-propofol and fentanyl-propofol for the insertion of laryngeal mask airway in children. J Anaesthesiol Clin Pharmacol. 2011 Jan;27(1):91-6.

  PMID: 21804715 BACKGROUND

MeSH Terms

Interventions

Ketamine; Sevoflurane; Nitrous Oxide

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Methyl Ethers; Ethers; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Nitrogen Oxides; Gases; Inorganic Chemicals; Nitrogen Compounds; Oxides; Oxygen Compounds

Study Officials

• leila Mansali Stambouli, MD PhD

  university Hospital of Fattouma Bourguiba, Monastir, TUNISIA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator and Clinical Professor

Model Details: Randomized, controlled and double blind assignment

Study Record Dates

• First Submitted: July 16, 2017
• First Posted: August 22, 2017
• Study Start: June 1, 2013
• Primary Completion: December 30, 2013
• Study Completion: December 31, 2013
• Last Updated: August 22, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)