跳至主要内容
临床试验/NCT07381036
NCT07381036尚未招募不适用

Comparison of Nebulized Ketamine With Nebulized Magnesium Sulfate for the Prevention of Postoperative Sore Throat in Adult Surgical Patients Undergoing General Anesthesia: Prospective Randomized Controlled Study

Sohag University0 个研究点目标入组 150 人开始时间: 2026年2月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
150
主要终点
To compare the incidence of Post operative sore throat method.

研究概览

简要总结

The aim of this study is to compare the efficacy of nebulized ketamine versus nebulized magnesium sulfate in reducing the incidence and severity of POST.

  • Primary outcome

• To compare the incidence of POST method.

  • Secondary outcomes

  • Onset, Severity, and duration of POST at 0, 2, 4, 6, 12, 24 hours postoperative.

  • The hemodynamics recording (HR, BP, MBP, pre and post nebulization)

  • Adverse Effects (e.g., sedation, cough, nausea, vomiting, ….)

详细描述

Post-operative sore throat (POST) is a common complication seen in patients after general anesthesia with endotracheal intubation although clinicians often regard it as a minor complication. The incidence of POST is estimated to be 21%-65% in different studies . The primary cause of POST is airway irritation and inflammation or trauma caused by an endotracheal tube; however, the airway may be extremely sensitive due to a preexisting comorbid condition. Regardless of its incidence and some preventive measures, POST is listed from the top as patients' most undesirable outcome in the postoperative period. POST is well recognized that reporting of sore throat is affected by the method of questioning that is whether the questions asked directly or indirectly .

The expression of POST constitutes a number of signs and symptoms. For example, sore throat is an ordinary expression of pharyngitis, which by itself can have a number of causes. It may also include a variety of symptoms including pain and discomfort, laryngitis, tracheitis, hoarseness, cough, or dysphagia. This leads to an increase in morbidity and causes further complications in patients .

Various pharmacological and nonpharmacological methods have been tried to decrease the incidence of POST with varying success rates. The pharmacological methods used for the prevention of POST are the use of inhalational, intravenous or topical agents that include beclomethasone gel, magnesium sulfate gargle, ketamine gargle, nebulized ketamine, magnesium sulfate nebulization, and lidocaine spray .

Nebulized medication administration is strongly recommended over intranasal delivery that is inhaled into the lungs and respiratory tract and is an important strategy for various respiratory problems and diseases. It reduces cough, temporary nasal discomfort, and vocal cord irritation. N-methyl-D-aspartate (NMDA) receptors had a crucial part in inflammation and nociception in the body. NMDA receptors exist in both peripheral nervous system (PNS) neurons and the central NS (CNS) .

Ketamine, an NMDA receptor antagonist, is commonly administered as a nebulizer to decline the severity and frequency of POST owing to its antinociceptive and anti-inflammatory properties .

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
Triple (Participant, Care Provider, Investigator)

入排标准

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

入选标准

  • Age from 18 to 65 years old.
  • Both sexes.
  • American Society of Anesthesiologists (ASA) physical status I-II.
  • Elective surgery requiring GA with endotracheal intubation.

排除标准

  • Surgery involves the oral cavity, nasopharynx, larynx, and neck regions.
  • Surgery requires prone position.
  • Surgery lasted more than 3 hours.
  • History of preoperative sore throat, common cold.
  • Anticipated difficult airway.
  • Any known allergies to study drugs.
  • Recent non-steroidal anti-inflammatory drugs use.
  • Pregnancy.

研究组 & 干预措施

Ketamine group

Experimental

干预措施: Ketamine nebulizer (Drug)

Mg sulfate group

Experimental

干预措施: Mg sulfate nebulizer (Drug)

Placebo group

Placebo Comparator

干预措施: Placebo (Drug)

结局指标

主要结局

To compare the incidence of Post operative sore throat method.

时间窗: 24 hours

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Shahenda Ahmed Ali

Resident of Anesthesia and surgical Intensive Care unit and Pain Management

Sohag University

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