The Application of Lidocaine Cream on Oral Secretions of LMA Removal During the Recovery Period in Ophthalmic Surgical Patients Under General Anesthesia

NCT06967064 | Withdrawn Phase 4

• 1 other identifier: 2000035364
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The application of lidocaine cream on oral secretions of LMA removal during the recovery period in ophthalmic surgical patients under general anesthesia: a randomized controlled trial

Conditions

Airway Complication of Anaesthesia; Laryngeal Mask Airway Removal; Anesthesia Emergence; Secretion; Excess, Salivation; Ophthalmic Surgery; General Anesthesia

Keywords

airway complication; oral secretions; laryngeal mask airway; general anesthesia; ophthalmic surgery

Outcome Measures

Primary Outcomes (1)

• The volume of oral secretions

  Oral secretions will be collected during the phase of anesthesia emergence. In the PACU, oral and nasopharyngeal secretions are gently suctioned using a negative pressure aspirator during the phase of emergence. Subsequently, 50 ml of normal saline is used to flush the suction tubing. The volume of oral secretions (ml) is calculated as the total volume in the suction canister minus 50 ml.

  Assessed during the phase of anesthesia emergence, from the discontinuation of anesthetic agents to eye opening or purposeful movement; and reported up to 4 weeks.

Secondary Outcomes (9)

• The time completion of LMA insertion

  Assessed from holding the airway tube to successful insertion of the LMA; and reported up to 4 weeks.

• Oropharyngeal leak pressure (OLP)

  Assessed after the completion of LMA insertion; and reported up to 4 weeks.

• Time to LMA removal

  Assessed from discontinuation of anesthetic agents to LMA removal; and reported up to 4 weeks.

• Time to emergence

  Assessed from the discontinuation of anesthetic agents to eye opening or purposeful movement; and reported up to 4 weeks.

• PACU recovery time

  Assessed from arrival in the PACU until the modified Aldrete score achieved at least 9; and reported up to 4 weeks.

Study Arms (3)

The uniform application group (group U)

EXPERIMENTAL

1 ml of lidocaine cream will be evenly applied to the posterior surface of the LMA cuff before insertion

Drug: lidocaine cream

The non-uniform application group (group N)

EXPERIMENTAL

1 mL of lidocaine cream will be applied to the posterior surface without ensuring uniform coverage before insertion

Drug: lidocaine cream

The control group (group C)

SHAM COMPARATOR

No lidocaine cream will be applied to the LMA

Other: Placebo

Interventions

lidocaine cream DRUG

Group U receives 1 mL of lidocaine cream extracted using a syringe and evenly applied across the entire posterior surface of the LMA cuff by carefully spreading the cream to ensure uniform coverage, while Group N receives 1 mL of lidocaine cream also extracted using a syringe but applied without ensuring even distribution, resulting in a patchy or non-uniform application.

The non-uniform application group (group N); The uniform application group (group U)

Placebo OTHER

No lidocaine cream will be applied to the LMA

The control group (group C)

Eligibility Criteria

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

You may qualify if:

• Aged 18 to 60 years;
• With American Society of Anesthesiologists (ASA) physical status I or II;
• Scheduled to undergo ophthalmic surgery following general anesthesia with LMA.

You may not qualify if:

• Contraindications to LMA use;
• A history of upper respiratory tract infection within one week prior to surgery;
• Persistent pharyngeal symptoms (eg. throat irritation, dryness, or chronic cough, etc.) lasting ≥ 3 months;
• Severe gastroesophageal reflux disease;
• Morbid obesity, defined as a body mass index ≥ 40 kg/m2;
• A predicted difficult airway (eg. a history of difficult airway, mouth opening \< 3 cm, Mallampati class 4, limited neck extension or cervical spine disease);
• Presence of structural abnormalities, masses, infections, or scarring in the oral cavity or oropharynx;
• Known contraindications to lidocaine cream;
• Two or more failed attempts at LMA insertion;
• Intraoperative administration of anticholinergic agents;
• Any other condition present likely to influence the study outcomes.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Related Publications (5)

• Seo JH, Cho CW, Hong DM, Jeon Y, Bahk JH. The effects of thermal softening of double-lumen endobronchial tubes on postoperative sore throat, hoarseness and vocal cord injuries: a prospective double-blind randomized trial. Br J Anaesth. 2016 Feb;116(2):282-8. doi: 10.1093/bja/aev414.

  PMID: 26787799 BACKGROUND

• van Esch BF, Stegeman I, Smit AL. Comparison of laryngeal mask airway vs tracheal intubation: a systematic review on airway complications. J Clin Anesth. 2017 Feb;36:142-150. doi: 10.1016/j.jclinane.2016.10.004. Epub 2016 Dec 3.

  PMID: 28183554 BACKGROUND

• Zhu Y, Shen W, Lin Y, Huang T, Xie L, Yang Y, Chen H, Gan X. Cricoid-mental distance-based versus weight-based criteria for size selection of classic laryngeal mask airway in adults: a randomized controlled study. J Clin Monit Comput. 2019 Oct;33(5):759-765. doi: 10.1007/s10877-019-00308-w. Epub 2019 Apr 8.

  PMID: 30963460 BACKGROUND

• Park JJ, Huh H, Yoon SZ, Lim HJ, Go DY, Cho JE, Lee J, Park J, Kim HC. Two-handed jaw thrust decreases postoperative sore throat in patients undergoing double-lumen endobronchial intubation: A randomised study. Eur J Anaesthesiol. 2020 Feb;37(2):105-112. doi: 10.1097/EJA.0000000000001149.

  PMID: 31860598 BACKGROUND

• Zhu YL, Shen WH, Chen QR, Ye HJ, Huang JX, Kang Y, Chi W, Gan XL. Desflurane anesthesia compared with total intravenous anesthesia on anesthesia-controlled operating room time in ambulatory surgery following strabotomy: a randomized controlled study. Chin Med J (Engl). 2020 Apr 5;133(7):779-785. doi: 10.1097/CM9.0000000000000728.

  PMID: 32149764 BACKGROUND

MeSH Terms

Conditions

Sialorrhea

Condition Hierarchy (Ancestors)

Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending doctor of anesthesiology, Zhongshan Ophthalmic Center, Sun Yat-sen University

Study Record Dates

• First Submitted: April 22, 2025
• First Posted: May 13, 2025
• Study Start: May 15, 2025
• Primary Completion: May 22, 2025
• Study Completion: May 22, 2025
• Last Updated: May 29, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share