Laryngeal Mask Insertion Conditions And Hemodynamic Effects

• ClinicalTrials.gov Identifier: NCT03257800
• Recruitment Status: Completed
• First Posted: August 22, 2017
• Last Update Posted: August 22, 2017
• Sponsor: Leila mansali stambouli
• Information provided by (Responsible Party): Leila mansali stambouli, University of Monastir

Tracking Information

• First Submitted Date: July 16, 2017
• First Posted Date: August 22, 2017
• Last Update Posted Date: August 22, 2017
• Actual Study Start Date: June 1, 2013
• Actual Primary Completion Date: December 30, 2013 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 18, 2017)

LMA insertion conditions [ Time Frame: 2 minutes ]

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

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: August 18, 2017)

hemodynamic effects [ Time Frame: from Baseline period until 10 minutes after LMA insertion ]

mean blood pressure (MAP) in mmHg . Heart Rate (HR) in beats per minute (time frame: from baseline to LMA insertion)

• Original Secondary Outcome Measures: Same as current

Current Other Pre-specified Outcome Measures (submitted: August 18, 2017)

delirium [ Time Frame: from awake until 30 min after emergence ]

Emergence delirium was assessed by the Pediatric Anesthesia Emergence Delirium Scale (PAED) and was defined as a PAED score >10

• Original Other Pre-specified Outcome Measures: Same as current

Descriptive Information

• Brief Title: Laryngeal Mask Insertion Conditions And Hemodynamic Effects
• Official Title: Laryngeal Mask Insertion Conditions And Hemodynamic Effects After Propofol And Ketamine-Propofol Co-induction
• 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.

Detailed 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.

• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Randomized, controlled and double blind assignment

Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Other

• Condition: 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
  Other Name: sevoflurane, nitrous oxide (N2O)
• Drug: 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
  Other Name: sevoflurane, N2O

Study Arms

• Active Comparator: ketamine-propofol group

  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.

  Intervention: Drug: Ketamine
• Placebo Comparator: propofol group

  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.

  Intervention: Drug: placebo

Publications *

• 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.
• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: August 18, 2017): 120
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: December 31, 2013
• Actual Primary Completion Date: December 30, 2013 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 1 Year to 8 Years (Child)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Tunisia

Administrative Information

• NCT Number: NCT03257800
• Other Study ID Numbers: 0925-0586
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Leila mansali stambouli, University of Monastir
• Original Responsible Party: Same as current
• Current Study Sponsor: Leila mansali stambouli
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: leila Mansali Stambouli, MD PhD; university Hospital of Fattouma Bourguiba, Monastir, TUNISIA

• PRS Account: University of Monastir
• Verification Date: August 2017