Clinical trial NCT06967064: The Application of Lidocaine Cream on Oral Secretions of LMA Removal During the Recovery Period in Ophthalmic Surgical Patients Under General Anesthesia
Official title: 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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
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
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2025-05-13
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The volume of oral secretions
timeFrame: 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:
measure: The time completion of LMA insertion
timeFrame: Assessed from holding the airway tube to successful insertion of the LMA; and reported up to 4 weeks.
measure: Oropharyngeal leak pressure (OLP)
timeFrame: Assessed after the completion of LMA insertion; and reported up to 4 weeks.
measure: Time to LMA removal
timeFrame: Assessed from discontinuation of anesthetic agents to LMA removal; and reported up to 4 weeks.
measure: Time to emergence
timeFrame: Assessed from the discontinuation of anesthetic agents to eye opening or purposeful movement; and reported up to 4 weeks.
measure: PACU recovery time
timeFrame: Assessed from arrival in the PACU until the modified Aldrete score achieved at least 9; and reported up to 4 weeks.
measure: Postoperative airway complications
timeFrame: Assessed at the time of LMA removal; and reported up to 4 weeks.
measure: Pharyngeal complications
timeFrame: Assessed at 1 h and 24 h postoperatively; and reported up to 4 weeks.
measure: The level of sore throat
timeFrame: Assessed at 1 h and 24 h postoperatively; and reported up to 4 weeks.
measure: Ocular and other complications
timeFrame: Assessed within 48 h after the surgery; and reported up to 4 weeks.
Other outcomes:
Locations:
Study officials:
References:
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citation: 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.
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citation: 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.