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

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Laryngeal Masks	Drug: Ketamine; Drug: placebo	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 120 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Randomized, controlled and double blind assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Other
• Official Title: Laryngeal Mask Insertion Conditions And Hemodynamic Effects After Propofol And Ketamine-Propofol Co-induction
• Actual Study Start Date: June 1, 2013
• Actual Primary Completion Date: December 30, 2013
• Actual Study Completion Date: December 31, 2013

Arms and Interventions

Arm	Intervention/treatment
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.	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)
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.	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

Outcome Measures

Primary Outcome Measures :

1. 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

Secondary Outcome Measures :

1. 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)

Other Outcome Measures:

1. 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

Eligibility Criteria

• Ages Eligible for Study: 1 Year to 8 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

Tunisia

University Hospital of Fattouma Bourguiba

Monastir, Tunisia, 5000

Sponsors and Collaborators

Leila mansali stambouli

Investigators

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

More Information

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.

• Responsible Party: Leila mansali stambouli, Principal Investigator and Clinical Professor, University of Monastir
• ClinicalTrials.gov Identifier: NCT03257800
• Other Study ID Numbers: 0925-0586
• First Posted: August 22, 2017
• Last Update Posted: August 22, 2017
• Last Verified: August 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

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

Keywords provided by Leila mansali stambouli, University of Monastir:

ketamine; Propofol; laryngeal masks; anesthesia; child

Additional relevant MeSH terms:

Ketamine; Nitrous Oxide; Sevoflurane; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Anesthetics, Dissociative; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Central Nervous System Depressants; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Platelet Aggregation Inhibitors; Anesthetics, Inhalation; Analgesics, Non-Narcotic