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临床试验/NCT05069844
NCT05069844已完成不适用

Preoperative Gum Chewing for Different Durations to Prevent Sore Throat After Endotracheal Intubation: A Randomized Controlled Trial

Ahmed Salah Ahmed Abd Elgalil2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2021年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
150
试验地点
2
主要终点
The incidence of moderate/severe postoperative sore throat (POST) within 24 hours after surgery POST within 24 hours after surgery

研究概览

简要总结

This study aims to evaluate the effect preoperative chewing gums for 2 or 4 minutes on postoperative sore throat after general anesthesia using an endotracheal tube.

详细描述

Pharmacological measures for attenuating postoperative sore throat (POST) include inhalation of beclomethasone or fluticasone propionate; gargling with azulene sulfonate, aspirin, or ketamine: gargling or spraying benzydamine hydrochloride; intravenous (IV) dexamethasone; oral clonidine; topical or systemic lidocaine; and ingestion of strepsils tablets. Each of these approaches has limitations and variable success rates; thus, no approach has become established in routine clinical use. In the past decade, studies have shown that xylitol in chewing gum may inhibit the growth, metabolism, and polysaccharide production of Streptococcus mutans, which accounts for the highest proportion of the natural flora in the oral cavity. Subsequent biofilm formation reduction may lead to some reduction in the number of bacteria. Furthermore, chewing gum can promote salivary gland secretion, resulting in lubrication and cleansing of the oral cavity. which may decrease postoperative sore throat.

Patients included in the study will be divided into 3 groups; the gum group2 (group G2), the gum group4 (group G4) and the control group (group C) by a computer-generated random number table before surgery. In the preoperative waiting area before transfer to the operating room, patients in group G2 will chew 1 piece of herbal sugar-free for 2 minutes and then spat it out, patients in group G4 will chew 1 piece of herbal sugar-free for 4 minutes and then spat it out, group C will be asked to swallow 2 times only. After entering to the OR patients will be routinely monitored with ECG, Pulse oximetry, and blood pressure then induction of anesthesia will be done using Fentanyl 1 to 2 mcg per kg, propofol 1 to 3 mg per kg, and atracurium 0.6 mg per kg. endotracheal tube size 7.5 will be inserted. volume-controlled ventilation was initiated with a mixture of 50% oxygen and 50% air, a respiratory rate of 12 cycles·minute, an inspiratory-to-expiratory ratio (I:E) of 1:2 and an adjusted end-tidal CO2 maintained at approximately 35-40 mm Hg. Ondansetron (4 mg) and paracetamol 1g were injected IV to prevent postoperative nausea, vomiting, and pain. Patients will be extubated after being awake using minimal suction. Postoperative sore throat (POST) will be evaluated by the numerical rating scale (NRS), which ranges from 0 to 10 points, with 0 indicating no pain, 1-3 indicating mild discomfort, 4-6 indicating moderate pain, and 7-10 indicating severe pain.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
21 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Provision of signed and dated informed consent form
  • Stated willingness to comply with all study procedures and availability for the duration of the study
  • Age 21-65 years
  • American Society of Anesthesiologists (ASA) physical I-II
  • Scheduled for elective breast surgery
  • Under general anesthesia.

排除标准

  • Chronic laryngitis
  • Chronic bronchitis
  • Gastroesophageal reflux
  • Allergies to study drugs
  • Recent use of nonsteroidal anti-inflammatory drugs (NSAIDs)
  • A history of upper respiratory tract infection
  • Smoking and steroid therapy in the past week
  • Failure to communicate normally
  • Mallampati grade >2

结局指标

主要结局

The incidence of moderate/severe postoperative sore throat (POST) within 24 hours after surgery POST within 24 hours after surgery

时间窗: 24 hours postoperative

The incidence of moderate/severe POST within 24 hours after surgery

次要结局

  • Postoperative sore throat (POST) numeric rating scale (NRS) scores 2, 6, and 24 hours after surgery(24 hours Postoperative)

研究者

发起方
Ahmed Salah Ahmed Abd Elgalil
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Ahmed Salah Ahmed Abd Elgalil

Lecturer of Anesthesiology and Pain Management

National Cancer Institute, Egypt

研究点 (2)

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