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

Airway Complication of Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03361397
• Other study ID #: 17100246
• Status: Not yet recruiting
• Phase: N/A
• First received: November 24, 2017
• Last updated: November 28, 2017
• Start date: November 30, 2017
• Est. completion date: April 30, 2018

Study information

• Verified date: November 2017
• Source: Assiut University
• Contact: Mohamed Aly, MD
• Phone: 00201062011126
• Email: galalm1967[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: April 30, 2018
• Est. primary completion date: April 2, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Airway Complication of Anesthesia

Intervention

Drug:
• Lidocaine Hydrochloride
Lidocaine hydrochloride will be used via mask nebulizer before LMA insertion
• Distilled Water
Distilled Water will be used via mask nebulizer before LMA insertion

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (2)

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. — View Citation

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. Epub 2005 Aug 26. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Heart rate	Beat /min	1, 3, 5 minutes after LMA insertion
Secondary	Arterial blood pressure	mm Hg	1, 3, 5 minutes after LMA insertion