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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

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

Status
Withdrawn
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06967064
Acronym
LICOS
Enrollment
0
Registered
2025-05-13
Start date
2025-05-15
Completion date
2025-05-22
Last updated
2025-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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

Detailed 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.

Interventions

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.

OTHERPlacebo

No lidocaine cream will be applied to the LMA

Sponsors

Sun Yat-sen University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
The volume of oral secretionsAssessed during the phase of anesthesia emergence, from the discontinuation of anesthetic agents to eye opening or purposeful movement; and reported up to 4 weeks.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.

Secondary

MeasureTime frameDescription
Oropharyngeal leak pressure (OLP)Assessed after the completion of LMA insertion; and reported up to 4 weeks.OLP is measured by setting the expiratory valve to 30 cmH2O at a gas flow rate of 3 L/min, recording the maximum inflation pressure when a noise of gas leakage is heard in the oropharynx via a stethoscope
Time to LMA removalAssessed from discontinuation of anesthetic agents to LMA removal; and reported up to 4 weeks.
Time to emergenceAssessed from the discontinuation of anesthetic agents to eye opening or purposeful movement; and reported up to 4 weeks.
PACU recovery timeAssessed from arrival in the PACU until the modified Aldrete score achieved at least 9; and reported up to 4 weeks.
The time completion of LMA insertionAssessed from holding the airway tube to successful insertion of the LMA; and reported up to 4 weeks.
Pharyngeal complicationsAssessed at 1 h and 24 h postoperatively; and reported up to 4 weeks.Pharyngeal complications, such as sore throat, dysphagia, or hoarseness, will be collected
The level of sore throatAssessed at 1 h and 24 h postoperatively; and reported up to 4 weeks.The level of sore throat will be graded as follows: none, no sore throat; mild, pain with deglutition; moderate, pain constantly present and increasing with deglutition; severe, pain interfering with eating and requiring analgesic medication
Ocular and other complicationsAssessed within 48 h after the surgery; and reported up to 4 weeks.
Postoperative airway complicationsAssessed at the time of LMA removal; and reported up to 4 weeks.Postoperative airway complications, including coughing, laryngospasm, or blood on device, will be recorded at the time of LMA removal

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026