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

Sun Yat-sen University

Status and phase: Withdrawn; Phase 4

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

Treatments: Other: Placebo; Drug: lidocaine cream

Study type: Interventional

Funder types: Other

Identifiers

NCT06967064

2000035364

Details and patient eligibility

About

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

Full description

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.

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 3 patient groups

The uniform application group (group U)

Experimental group

Description:

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

Treatment:

Drug: lidocaine cream

The non-uniform application group (group N)

Experimental group

Description:

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

Treatment:

Drug: lidocaine cream

The control group (group C)

Sham Comparator group

Description:

No lidocaine cream will be applied to the LMA

Treatment:

Other: Placebo