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

NCT03361397 | Unknown DMC

• 1 other identifier: 17100246
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief 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).

Conditions

Airway Complication of Anesthesia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Heart rate

  1, 3, 5 minutes after LMA insertion

• Arterial blood pressure

  1, 3, 5 minutes after LMA insertion

Study Arms (2)

Lidocaine nebulization

ACTIVE COMPARATOR

Inhalation of 10 mL nebulized lidocaine hydrochloride via mask nebulizer 5 min before laryngeal mask insertion.

Drug: Lidocaine Hydrochloride

Distilled water nebulization

PLACEBO COMPARATOR

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

Interventions

Lidocaine Hydrochloride DRUG

Lidocaine hydrochloride will be used via mask nebulizer before LMA insertion

Also known as: Xylocaine

Lidocaine nebulization

Distilled Water DRUG

Distilled Water will be used via mask nebulizer before LMA insertion

Also known as: DW

Distilled water nebulization

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Related 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.

  PMID: 21804711 BACKGROUND

• 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.

  PMID: 16126785 BACKGROUND

MeSH Terms

Interventions

Lidocaine

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Central Study Contacts

Mohamed Aly, MD

CONTACT

00201062011126; galalm1967@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor of anesthesia

Study Record Dates

• First Submitted: November 24, 2017
• First Posted: December 4, 2017
• Study Start: November 30, 2017
• Primary Completion: April 2, 2018
• Study Completion: April 30, 2018
• Last Updated: December 4, 2017

Record last verified: 2017-11