Effect of Nebulized Lidocaine on the Quality of Laryngeal Mask Airway Insertion

Effect of Nebulized Lidocaine on the Quality of Laryngeal Mask Airway Insertion: A Randomized, Double Blind, Controlled Study

The primary outcome of this study will be the effect of lidocaine nebulization before LMA insertion on LMA insertion score (within 1 minute of LMA insertion) in adult patients undergoing surgery under general anesthesia.

The secondary outcome measures are the effect of LMA insertion on heart rate, arterial blood pressure, SpO2, the first time insertion rate of the LMA, and postoperative complications during LMA removal (soft tissue trauma, coughing, and laryngospasm).

Study Overview

• Status: Unknown
• Conditions: Airway Complication of Anesthesia
• Intervention / Treatment: Drug: Lidocaine Hydrochloride; Drug: Distilled Water

Detailed Description

Patients will be randomly allocated into two groups of equal size to receive lidocaine nebulization, group L (GL) or distilled water nebulization, group W (GW/control). Randomization will be performed using GL and GW registers, which will be placed in sealed envelopes prior to study initiation and opened prior to anesthesia by a physician who will prepare the solution for nebulization and will identify it with the patient number, according to the envelope drawn. Group L patients (n = 40) will receive 10 mL lidocaine 4%, and GW patients (n = 40) will receive 10 mL distilled water (DW) by nebulizer mask 5 min prior to anesthesia. All patients will be preoxygenated with 100% oxygen for 3 minutes via mask gently placed over the face and thereafter Propofol 2.5 mg/kg slowly IV plus Fentanyl 1 µg/kg IV will be used for induction of anesthesia, and isoflurane for maintenance of anesthesia in both groups.

After confirming sufficient level of anesthesia (loss of eye lash reflex and jaw relaxation), the standard technique for LMA insertion (Brain,s method) will be used in both groups. Water based jelly will be applied on the posterior surface of the LMA and pressed along the palato-pharyngeal curve using the index finger. It is finally pushed further down till resistance is felt. A size 3 LMA will be used in women and a size 4 in men. Proper placement of LMA will be confirmed with bilateral equally audible breath sounds, chest movements and square wave capnography. Patients will be allowed to breathe spontaneously after successful LMA insertion.

The overall insertion condition will be assessed via a modified three point scale consisting of six variables, which include:

Mouth opening (3: full; 2: partial; 1: none) Ease of insertion (3: easy; 2: difficult; 1: impossible) Swallowing (3: nil; 2: slight; 1: gross) Coughing or gagging (3: nil; 2: slight; 1: gross) Head or limbs movement (3: nil; 2: slight; 1: gross), and Laryngospasm (3: nil; 2: partial; 1: total). Total score Insertion condition 18 Excellent 16-17 Satisfactory <16 Poor Any failure of insertion in both groups (defined as failure to insert the LMA after 3rd time), will be managed by endotracheal intubation.

At the end of the operation, LMA will be removed under deep anesthesia and replaced with Guedel's airway. Oxygen will be continued with a face mask until full recovery, and then the patients will be moved to the PACU.

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Adult patients (Age >18 yrs)
• ASA grade 1&2
• Scheduled to undergo various elective surgical procedures under general anesthesia using LMA.

Exclusion Criteria:

• Patients requiring endotracheal intubation
• Heavy smokers
• Grossly obese patients (Body mass index >35 kg/m2)
• Patients with suspected difficult airway (Mallampati Grade III or IV)
• Hypersensitivity to the used drugs
• Significant cardiovascular
• Significant pulmonary disease
• liver disease.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Lidocaine nebulization; Inhalation of 10 mL nebulized lidocaine hydrochloride via mask nebulizer 5 min before laryngeal mask insertion.	Drug: Lidocaine Hydrochloride; Lidocaine hydrochloride will be used via mask nebulizer before LMA insertion; Other Names: Xylocaine
PLACEBO_COMPARATOR: Distilled water nebulization; Inhalation of 10 mL of nebulized distilled water solution via mask nebulizer 5 min before laryngeal mask insertion in the preoperative period.	Drug: Distilled Water; Distilled Water will be used via mask nebulizer before LMA insertion; Other Names: DW

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
LMA insertion score	modified three point scale consisting of six variables, which measures the easiness of LMA insertion. Total score Insertion condition 18 Excellent 16-17 Satisfactory <16 Poor	within 1 minute of LMA insertion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart rate	Beat /min	1, 3, 5 minutes after LMA insertion
Arterial blood pressure	mm Hg	1, 3, 5 minutes after LMA insertion

Collaborators and Investigators

• Sponsor: Assiut University

Publications and helpful links

General Publications

• Gupta A, Kaur S, Attri JP, Saini N. Comparative evaluation of ketamine - propofol, fentanyl - propofol and butorphanol-propofol on haemodynamics and laryngeal mask airway insertion conditions. J Anaesthesiol Clin Pharmacol. 2011 Jan;27(1):74-8.
• Williams KA, Barker GL, Harwood RJ, Woodall NM. Combined nebulization and spray-as-you-go topical local anaesthesia of the airway. Br J Anaesth. 2005 Oct;95(4):549-53. doi: 10.1093/bja/aei202. Epub 2005 Aug 26.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): November 30, 2017
• Primary Completion (ANTICIPATED): April 2, 2018
• Study Completion (ANTICIPATED): April 30, 2018

Study Registration Dates

• First Submitted: November 24, 2017
• First Submitted That Met QC Criteria: November 28, 2017
• First Posted (ACTUAL): December 4, 2017

Study Record Updates

• Last Update Posted (ACTUAL): December 4, 2017
• Last Update Submitted That Met QC Criteria: November 28, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: 17100246

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No