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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-15

Study Completion Date

2025-05-22

Brief Summary

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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

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Detailed Description

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During the recovery from general anesthesia, patients commonly experience heightened oral secretions, which can elevate intraocular pressure (IOP) due to coughing and potentially lead to the infiltration of secretions into the surgical site via the nasolacrimal duct, increasing the risk of endophthalmitis. This study is aimed to investigate whether applying lidocaine cream to the laryngeal mask airway (LMA) reduces oral secretions during emergence from general anesthesia in ophthalmic surgery patients.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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The uniform application group (group U)

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

Group Type EXPERIMENTAL

lidocaine cream

Intervention Type 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)

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

Group Type EXPERIMENTAL

lidocaine cream

Intervention Type 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 control group (group C)

No lidocaine cream will be applied to the LMA

Group Type SHAM_COMPARATOR

Placebo

Intervention Type OTHER

No lidocaine cream will be applied to the LMA

Interventions

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lidocaine cream

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.

Intervention Type DRUG

Placebo

No lidocaine cream will be applied to the LMA

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No