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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.
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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: 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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| 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 |
|
| The control group (group C) | Sham Comparator | No lidocaine cream will be applied to the LMA |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| lidocaine cream | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| The time completion of LMA insertion | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26787799 | Result | 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. | |
| 28183554 | Result | 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. |
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|
| Placebo | Other | No lidocaine cream will be applied to the LMA |
|
| Assessed after the completion of LMA insertion; and reported up to 4 weeks. |
| Time to LMA removal | Assessed from discontinuation of anesthetic agents to LMA removal; and reported up to 4 weeks. |
| Time to emergence | Assessed from the discontinuation of anesthetic agents to eye opening or purposeful movement; and reported up to 4 weeks. |
| PACU recovery time | 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 | 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 | 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 | Assessed at 1 h and 24 h postoperatively; and reported up to 4 weeks. |
| Ocular and other complications | Assessed within 48 h after the surgery; and reported up to 4 weeks. |
| 30963460 | Result | 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. |
| 31860598 | Result | 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. |
| 32149764 | Result | 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. |
| ID | Term |
|---|---|
| D012798 | Sialorrhea |
| ID | Term |
|---|---|
| D012466 | Salivary Gland Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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