Airway Complication of AnaesthesiaPhase 4LICOSNCT06967064

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

A Phase 4 study testing lidocaine cream in people with Airway Complication of Anaesthesia and Laryngeal Mask Airway Removal, run by Sun Yat-sen University.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record

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Trial 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 Read more about this study

Who is it for?: Ages 18 to 60 years
Conditions the study is for: Airway Complication of Anaesthesia, Laryngeal Mask Airway Removal, Anesthesia Emergence
What is being tested?: lidocaine cream
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 0 participants
Where: No sites listed yet
Study dates: 15 May 2025to 22 May 2025
Phase: Phase 4
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 60 years
All sexes
No healthy volunteers
Adult

Who may be able to join

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.

Who cannot join

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);

Show all 11Show fewer

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.

About this study

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

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

Read the 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.

Conditions: Airway Complication of Anaesthesia, Laryngeal Mask Airway Removal, Anesthesia Emergence, Secretion; Excess, Salivation, Ophthalmic Surgery, General Anesthesia
Being tested: lidocaine cream, Placebo
Keywords: airway complication, oral secretions, laryngeal mask airway, general anesthesia, ophthalmic surgery
Medical subject headings: Sialorrhea

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

lidocaine creamDrug
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.
PlaceboOther
No lidocaine cream will be applied to the LMA

Study groups in NCT06967064
Study group	Role	What they receive
The uniform application group (group U)	Experimental	1 ml of lidocaine cream will be evenly applied to the posterior surface of the LMA cuff before insertion Receives: Drug: lidocaine cream
The non-uniform application group (group N)	Experimental	1 mL of lidocaine cream will be applied to the posterior surface without ensuring uniform coverage before insertion Receives: Drug: lidocaine cream
The control group (group C)	Sham comparator	No lidocaine cream will be applied to the LMA Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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 (9)

The time completion of LMA insertion
Measured: 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
Measured: Assessed after the completion of LMA insertion; and reported up to 4 weeks.
Time to LMA removal
Measured: Assessed from discontinuation of anesthetic agents to LMA removal; and reported up to 4 weeks.
Time to emergence
Measured: Assessed from the discontinuation of anesthetic agents to eye opening or purposeful movement; and reported up to 4 weeks.
PACU recovery time
Measured: 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
Measured: 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
Measured: 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
Measured: Assessed at 1 h and 24 h postoperatively; and reported up to 4 weeks.
Ocular and other complications
Measured: Assessed within 48 h after the surgery; and reported up to 4 weeks.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 May 202522 May 2025

First posted13 May 2025
Study start15 May 2025
Primary completion22 May 2025
Study completion22 May 2025

Why it stopped: The study was proactively suspended to ensure alignment with all applicable regulatory filing procedures. This decision was made to maintain adherence to institutional and compliance standards prior to study initiation.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (5)Papers the sponsor has linked to this study.
Other trials for Airway Complication of AnaesthesiaStudies of the same condition, open and under way.
More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06967064
Sponsor's protocol ID: 2000035364
Acronym: LICOS
Status last verified: May 2025
First submitted: 22 Apr 2025
Last updated: 29 May 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Seo JH, Cho CW, Hong DM, Jeon Y, Bahk JH. The effects of thermal softening of double-lumen endobronchial tubes on postoperative sore throat, hoarseness and vocal cord injuries: a prospective double-blind randomized trial. Br J Anaesth. 2016 Feb;116(2):282-8. doi: 10.1093/bja/aev414.
PubMed 26787799
van Esch BF, Stegeman I, Smit AL. Comparison of laryngeal mask airway vs tracheal intubation: a systematic review on airway complications. J Clin Anesth. 2017 Feb;36:142-150. doi: 10.1016/j.jclinane.2016.10.004. Epub 2016 Dec 3.
PubMed 28183554
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.
PubMed 30963460
Park JJ, Huh H, Yoon SZ, Lim HJ, Go DY, Cho JE, Lee J, Park J, Kim HC. Two-handed jaw thrust decreases postoperative sore throat in patients undergoing double-lumen endobronchial intubation: A randomised study. Eur J Anaesthesiol. 2020 Feb;37(2):105-112. doi: 10.1097/EJA.0000000000001149.
PubMed 31860598
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.
PubMed 32149764

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Airway Complication of Anaesthesia trials

Study at a glance

From the registry record, last updated by the sponsor on 29 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT06967064
Acronym / sponsor ID: LICOS / 2000035364
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
Phase: Phase 4
Study type: Interventional
Recruitment status: WithdrawnReason stopped: The study was proactively suspended to ensure alignment with all applicable regulatory filing procedures. This decision was made to maintain adherence to institutional and compliance standards prior to study initiation.
Enrolment: 0 participants (actual)
Lead sponsor: Sun Yat-sen UniversityUniversity, hospital or other
Study start: 15 May 2025 (actual)
Primary completion: 22 May 2025 (actual)
Study completion: 22 May 2025 (actual)
First posted: 13 May 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
The uniform application group (group U)	Experimental	Drug: lidocaine cream1 ml of lidocaine cream will be evenly applied to the posterior surface of the LMA cuff before insertion
The non-uniform application group (group N)	Experimental	Drug: lidocaine cream1 mL of lidocaine cream will be applied to the posterior surface without ensuring uniform coverage before insertion
The control group (group C)	Sham comparator	Other: PlaceboNo lidocaine cream will be applied to the LMA

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (11 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
lidocaine creamGroup 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.	Drug	The non-uniform application group (group N), The uniform application group (group U)
PlaceboNo lidocaine cream will be applied to the LMA	Other	The control group (group C)

Primary outcome

The volume of oral secretions
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.
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.

9 secondary outcomes

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)
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
Time frame: Assessed at the time of LMA removal; and reported up to 4 weeks.
Pharyngeal complications
Time frame: Assessed at 1 h and 24 h postoperatively; and reported up to 4 weeks.
The level of sore throat
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.

Results and safety

The study was withdrawn before enrolling participants, so there are no results.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2025.
Results publication: PubMed 26787799Seo JH, Cho CW, Hong DM, Jeon Y, Bahk JH. The effects of thermal softening of double-lumen endobronchial tubes on postoperative sore throat, hoarseness and vocal cord injuries: a prospective double-blind randomized trial. Br J Anaesth. 2016 Feb;116(2):282-8. doi: 10.1093/bja/aev414.
Results publication: PubMed 28183554van Esch BF, Stegeman I, Smit AL. Comparison of laryngeal mask airway vs tracheal intubation: a systematic review on airway complications. J Clin Anesth. 2017 Feb;36:142-150. doi: 10.1016/j.jclinane.2016.10.004. Epub 2016 Dec 3.
Results publication: PubMed 30963460Zhu 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.
Results publication: PubMed 31860598Park JJ, Huh H, Yoon SZ, Lim HJ, Go DY, Cho JE, Lee J, Park J, Kim HC. Two-handed jaw thrust decreases postoperative sore throat in patients undergoing double-lumen endobronchial intubation: A randomised study. Eur J Anaesthesiol. 2020 Feb;37(2):105-112. doi: 10.1097/EJA.0000000000001149.
Results publication: PubMed 32149764Zhu 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing lidocaine cream in people with Airway Complication of Anaesthesia and Laryngeal Mask Airway Removal, run by Sun Yat-sen University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 29 May 2025. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The volume of oral secretions (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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06967064, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2025.