Comparison of Preoperative Topical Magnesium Sulfate Spraying and Magnesium Sulfate Gargling for the Prevention of Postoperative Sore Throat after Tracheal Intubation: A Randomized, Double-Blind, Non-Inferiority Trial.

IF 4.7 2区医学 Q1 CHEMISTRY, MEDICINAL Drug Design, Development and Therapy Pub Date : 2025-03-11 eCollection Date: 2025-01-01 DOI:10.2147/DDDT.S502081

Linxin Wang, Yuqing Liu, Fangfang Li, Qin Qiu, Xingyu Xiong, Guanglei Wang

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Abstract

Background and aim: Postoperative sore throat is a common complication following endotracheal intubation, which can significantly affect patient comfort and recovery. The purpose of this study is that compares the efficacy of preoperative topical magnesium sulfate spraying with that of magnesium sulfate gargling aimed at preventing postoperative sore throat.

Patients and methods: 236 Participants were randomly allocated to either the magnesium sulfate spray group (Group A) or the magnesium sulfate gargle group (Group B), with 118 patients in each group. In Group A, during intubation under direct laryngoscopy, 15 mg/kg of magnesium sulfate was sprayed using a single-use otorhinolaryngology anesthesia sprayer onto the pharyngeal mucosa and posterior pharyngeal wall near the glottis. In Group B, gargling with 20 mg/kg of magnesium sulfate for 30 seconds 15 minutes before surgery. The primary outcome measure was the total incidence of postoperative sore throat within 48 hours, with a non-inferiority margin of 0.15.

Results: The upper limit of the 95% confidence interval (CI) for the difference in the total incidence of POST between Group A and Group B was below the non-inferiority margin (0.15) (non-inferiority P<0.001). The upper limits of the 95% CI for the differences in the incidence rates of POST between Group A and Group B at time points T1- T6 were all below the non-inferiority margin (all non-inferiority P<0.001). The total incidence of POST (P=0.046) and the incidence of POST at T2-T4 (all P<0.001) in group A were lower than those in group B. The analysis of the individual effects between groups indicated significant differences in POST NRS scores at T1 (P=0.034) and T2-T4 (all P<0.001).

Conclusion: The local spray of magnesium sulfate on the throat before surgery to prevent postoperative sore throat is not inferior to, and may even be superior to, gargling with magnesium sulfate.

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背景和目的：术后咽喉痛是气管插管后常见的并发症，会严重影响患者的舒适度和康复。本研究旨在比较术前局部喷洒硫酸镁和硫酸镁漱口对预防术后咽喉炎的疗效。患者和方法：236 名参与者被随机分配到硫酸镁喷洒组（A 组）或硫酸镁漱口组（B 组），每组 118 名患者。在 A 组中，在直接喉镜下插管时，使用一次性耳鼻喉科麻醉喷雾器将 15 毫克/千克硫酸镁喷洒在声门附近的咽粘膜和咽后壁上。在 B 组中，术前 15 分钟用 20 毫克/千克硫酸镁漱口 30 秒。主要结果指标是术后 48 小时内咽喉疼痛的总发生率，非劣效差为 0.15：结果：A组和B组之间术后咽喉痛总发生率差异的95%置信区间（CI）上限低于非劣效边际（0.15）（非劣效PPP=0.046），T2-T4（所有PP=0.034）和T2-T4（所有PC结论：术后咽喉痛总发生率的95%置信区间（CI）上限低于非劣效边际（0.15）：手术前在咽喉局部喷洒硫酸镁以预防术后咽喉痛的效果并不差，甚至可能优于用硫酸镁漱口。

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来源期刊

Drug Design, Development and Therapy CHEMISTRY, MEDICINAL-PHARMACOLOGY & PHARMACY

CiteScore

9.00

自引率

0.00%

发文量

382

审稿时长

>12 weeks

期刊介绍： Drug Design, Development and Therapy is an international, peer-reviewed, open access journal that spans the spectrum of drug design, discovery and development through to clinical applications. The journal is characterized by the rapid reporting of high-quality original research, reviews, expert opinions, commentary and clinical studies in all therapeutic areas. Specific topics covered by the journal include: Drug target identification and validation Phenotypic screening and target deconvolution Biochemical analyses of drug targets and their pathways New methods or relevant applications in molecular/drug design and computer-aided drug discovery* Design, synthesis, and biological evaluation of novel biologically active compounds (including diagnostics or chemical probes) Structural or molecular biological studies elucidating molecular recognition processes Fragment-based drug discovery Pharmaceutical/red biotechnology Isolation, structural characterization, (bio)synthesis, bioengineering and pharmacological evaluation of natural products** Distribution, pharmacokinetics and metabolic transformations of drugs or biologically active compounds in drug development Drug delivery and formulation (design and characterization of dosage forms, release mechanisms and in vivo testing) Preclinical development studies Translational animal models Mechanisms of action and signalling pathways Toxicology Gene therapy, cell therapy and immunotherapy Personalized medicine and pharmacogenomics Clinical drug evaluation Patient safety and sustained use of medicines.