Contemporary clinical trials communications · 2026
A randomized, double-blind, placebo-controlled trial protocol evaluating preoperative medical oral rinse for reducing postoperative xerostomia and improving recovery in elderly patients undergoing pulmonary surgery.
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Xia Sijun, Jiang Zhiguo, Jiang Lin, Chen Wenjia
Аннотация
BACKGROUND: Postoperative dry mouth (xerostomia) is a common and distressing complication following general anesthesia, particularly in elderly patients undergoing pulmonary surgery. It is primarily caused by reduced salivary secretion associated with anesthetic agents, preoperative fasting, and airway instrumentation. However, effective preventive strategies remain limited, and the potential role of preoperative oral care interventions has not been fully established.
METHODS: This is a single-center, randomized, placebo-controlled trial with participants, anesthesiologists, surgeons, postoperative care nurses, outcome assessors, and data analysts blinded to treatment allocation. A total of 106 elderly patients (aged 65-80 years) scheduled for elective pulmonary surgery will be enrolled and randomly allocated in a 1:1 ratio to receive either a preoperative medical oral rinse (Beijing Tong Ren Tang, containing polyvinylpyrrolidone, sodium carboxymethyl cellulose, glycerol, N-acetylglucosamine, sorbitol, sodium saccharin, lactic acid, and purified water; 15 mL per rinse, administered 2 h before induction, repeated once for a total of 30 mL) or sterile normal saline as a placebo. The primary outcome is the severity of postoperative dry mouth, assessed using a visual analogue scale (VAS, 0-10) at 2 h after extubation. Secondary outcomes include sedation score, cough response, oral health status, hypoxemia, postoperative nausea and vomiting, and quality of recovery measured by the QoR-15 questionnaire at 24 h. Data will be analyzed according to the intention-to-treat principle using SPSS version 25.0.
DISCUSSION: This trial aims to evaluate whether a simple preoperative oral rinse intervention can reduce postoperative xerostomia and improve early postoperative recovery in elderly patients undergoing pulmonary surgery. The findings may provide evidence for an easy-to-implement, non-invasive strategy to enhance perioperative care and patient comfort.
TRIAL REGISTRATION: This study protocol was registered with the Chinese Clinical Trial Registry (Registration number: ChiCTR2500113507). Date of registration: December 1, 2025.
METHODS: This is a single-center, randomized, placebo-controlled trial with participants, anesthesiologists, surgeons, postoperative care nurses, outcome assessors, and data analysts blinded to treatment allocation. A total of 106 elderly patients (aged 65-80 years) scheduled for elective pulmonary surgery will be enrolled and randomly allocated in a 1:1 ratio to receive either a preoperative medical oral rinse (Beijing Tong Ren Tang, containing polyvinylpyrrolidone, sodium carboxymethyl cellulose, glycerol, N-acetylglucosamine, sorbitol, sodium saccharin, lactic acid, and purified water; 15 mL per rinse, administered 2 h before induction, repeated once for a total of 30 mL) or sterile normal saline as a placebo. The primary outcome is the severity of postoperative dry mouth, assessed using a visual analogue scale (VAS, 0-10) at 2 h after extubation. Secondary outcomes include sedation score, cough response, oral health status, hypoxemia, postoperative nausea and vomiting, and quality of recovery measured by the QoR-15 questionnaire at 24 h. Data will be analyzed according to the intention-to-treat principle using SPSS version 25.0.
DISCUSSION: This trial aims to evaluate whether a simple preoperative oral rinse intervention can reduce postoperative xerostomia and improve early postoperative recovery in elderly patients undergoing pulmonary surgery. The findings may provide evidence for an easy-to-implement, non-invasive strategy to enhance perioperative care and patient comfort.
TRIAL REGISTRATION: This study protocol was registered with the Chinese Clinical Trial Registry (Registration number: ChiCTR2500113507). Date of registration: December 1, 2025.