A Phase 4 interventional study of lidocaine cream and Placebo in Airway Complication of Anaesthesia, Laryngeal Mask Airway Removal and Anesthesia Emergence, sponsored by Sun Yat-sen University. Withdrawn. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2025-05-29.
Sponsored by Sun Yat-sen University · Phase 4, Interventional, and Prevention
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
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.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
1 ml of lidocaine cream will be evenly applied to the posterior surface of the LMA cuff before insertion
Drug: lidocaine cream
1 mL of lidocaine cream will be applied to the posterior surface without ensuring uniform coverage before insertion
Drug: lidocaine cream
No lidocaine cream will be applied to the LMA
Other: Placebo
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.
No lidocaine cream will be applied to the LMA
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.
Time frame: 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.
The time completion of LMA insertion
Time frame: Assessed from holding the airway tube to successful insertion of the LMA; and reported up to 4 weeks.
Oropharyngeal leak pressure (OLP)
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 frame: Assessed after the completion of LMA insertion; and reported up to 4 weeks.
Time to LMA removal
Time frame: Assessed from discontinuation of anesthetic agents to LMA removal; and reported up to 4 weeks.
Time to emergence
Time frame: Assessed from the discontinuation of anesthetic agents to eye opening or purposeful movement; and reported up to 4 weeks.
PACU recovery time
Time frame: Assessed from arrival in the PACU until the modified Aldrete score achieved at least 9; and reported up to 4 weeks.
Postoperative airway complications
Postoperative airway complications, including coughing, laryngospasm, or blood on device, will be recorded at the time of LMA removal
Time frame: Assessed at the time of LMA removal; and reported up to 4 weeks.
Pharyngeal complications
Pharyngeal complications, such as sore throat, dysphagia, or hoarseness, will be collected
Time frame: Assessed at 1 h and 24 h postoperatively; and reported up to 4 weeks.
The level of sore throat
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
Time frame: Assessed at 1 h and 24 h postoperatively; and reported up to 4 weeks.
Ocular and other complications
Time frame: Assessed within 48 h after the surgery; and reported up to 4 weeks.
No study locations are listed for this record.
Plan to share: No
Ran from May 2025 to primary completion in May 2025, 0 months.
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Studies of the drug tested here: Lidocaine