Laryngeal Mask Insertion Conditions And Hemodynamic Effects

Laryngeal Masks Clinical Trial

Official title:

Laryngeal Mask Insertion Conditions And Hemodynamic Effects After Propofol And Ketamine-Propofol Co-induction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03257800
• Other study ID #: 0925-0586
• Status: Completed
• Phase: N/A
• First received: July 16, 2017
• Last updated: August 18, 2017
• Start date: June 1, 2013
• Est. completion date: December 31, 2013

Study information

• Verified date: August 2017
• Source: University of Monastir
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This study aims to compare two anesthesia protocols: propofol induction with or without a prior injection of ketamine, in term of LMA insertion conditions(favorable= satisfactory or unfavorable= unsatisfactory ) and hemodynamic effects (decrease of 20 % from baseline of blood pressure and heart rate).

The conditions of LMA insertion have been assessed in each study group by an experimented anesthesiologist, who was unaware of the treatment group assignment. Conditions were considered satisfactory, if the 4 following criteria were acceptable: the jaw was relaxed, there was no coughing, swallowing and no limb movement, and then the LMA was inserted. When the investigators save at least one unacceptable of these criteria, conditions were considered to be unsatisfactory and thereafter anesthesia was deepened with supplemental dose of propofol 1mg.kg-¹ and 1 minute later a reinsertion was attempted. The total number of attempts at LMA insertion was recorded. Children trachea was intubated after 3 failed attempts of LMA insertion, and then patient was excluded.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: December 31, 2013
• Est. primary completion date: December 30, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 8 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Laryngeal Masks

Intervention

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

Locations

Country	Name	City	State
Tunisia	University Hospital of Fattouma Bourguiba	Monastir

Sponsors (1)

Lead Sponsor	Collaborator
Leila mansali stambouli

Country where clinical trial is conducted

Tunisia, 

References & 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	delirium	Emergence delirium was assessed by the Pediatric Anesthesia Emergence Delirium Scale (PAED) and was defined as a PAED score >10	from awake until 30 min after emergence
Primary	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	hemodynamic effects	mean blood pressure (MAP) in mmHg . Heart Rate (HR) in beats per minute (time frame: from baseline to LMA insertion)	from Baseline period until 10 minutes after LMA insertion