跳至主要内容
临床试验/CTRI/2024/03/064770
CTRI/2024/03/064770尚未招募Phase 3 4

To compare the efficacy of intravenous dexamethasone and dexmedetomidine in post operative sore throat(POST) on adult surgical patients in laproscopic cholecystectomy - a randomized control trial .

Jawaharlal Nehru Medical College and hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年4月2日最近更新:

试验速览

阶段
Phase 3 4
状态
尚未招募
入组人数
60
试验地点
1
主要终点
to compare the incidence of sore throat

研究概览

简要总结

Post-operative sore throat (POST) is caused by transient irritation to the local mucosa of the oropharynx or trachea after intubation-related manipulations is one of the most undesirable intubation-related complications with an estimated incidence of 14.5% to 65%. POST can significantly reduce the patients’ satisfaction level and affect their recovery.1

Numerous factors including age, female gender, smoking history, size of the endotracheal tube, cuff pressure, time and manipulations needed to insert the tube, and time of operation and anaesthesia may affect the incidence of POST, causing discomfort and dissatisfaction.2

Sore throat is often the predominant post-operative complaint when surgical pain is well controlled, particularly by local/regional analgesia. Factors contributing to the development of sore throat include trauma to pharyngolaryngeal mucosa from laryngoscopy, placement of a nasogastric tube, or oral suctioning, cuff design, pressure affecting tracheal mucosal capillary perfusion and contact of the tracheal tube with the vocal cords and posterior pharyngeal wall resulting in edema or mucosal lesions.3

A lot of research work has been published in past for reducing POST and hoarseness of voice either as non-pharmacological or pharmacological methods. Non-pharmacological methods includes use of appropriate size of endotracheal tube, presence or absence of cuff or use of airway adjuncts like stylet or bougie, and pharmacological methods includes various drugs administered intravenous or topically. These drugs include ketamine, lignocaine, aspirin, dexamethasone dexmedetomidine and magnesium sulfate.4

Dexamethasone is a potent corticosteroid with analgesic, anti-inflammatory and antiemetic action. Pre-operative dexamethasone has been reported to reduce the incidence of post-operative pain. It reduces the production of inflammatory mediator prostaglandins and leukotrienes. The mechanism behind this is inhibition of phospholipase-A2 through production of calcium-dependent phospholipid-binding proteins known as annexins and cyclooxygenase.5

Dexmedetomidine, a selective α2-adrenaline receptor agonist, has a dose-dependent sedative effect on respiration with minimal depressive effects. It also attenuates the inflammatory response. Several clinical experiments have been conducted to investigate the efficacy and safety of dexmedetomidine for the prevention of POST.6

It is a very versatile drug in anaesthesia practice, finding place in increasing number of clinical scenarios. Dexmedetomidine enhances anaesthesia produced by other anaesthetic drugs, causes pre-operative sympatholysis and decreases blood pressure by stimulating central α2 and imidazoline receptors.

Higher affinity to α2 receptor selectively leads to vagomimetic action on heart (bradycardia) and vasodilatation. The role as an antishivering agent and diuretic is yet to be established.7

Dexamethasone and Dexmedetomidine reduces the incidence of postoperative sore throat, pain and swelling because they act as an anti-inflammatory mediator.8

Accordingly, dexmedetomidine has been widely used as an adjunctive drug by anaesthetists during clinical procedures and surgeries. Tracheal intubation may be one mechanism contributing to POST. Tracheal intubation, the most commonly used airway management method during general anaesthesia, is safe for future clinical work. Previous studies suggest that dexamethasone is effective in decreasing the incidence of POST when given via intravenous route.9

When we searched the literature, there was no study comparing the efficacy of intravenous dexmedetomidine and dexamethasone so we took up the present study.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Investigator Blinded

入排标准

年龄范围
20.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • ASA grade 1 and grade 2 age between
  • 60 years weight between
  • 80 kg patient planned for elective laproscopic cholecystectomy surgeries.

排除标准

  • patient already on steroid therapy surgery more than one hour history of smoking diabetes mellitus , pregnancy NSAID use within 24 hrs before surgery recent history of respiratory tract infection risk factor for postoperative aspiration cardiac hepatic or major renal disease neuromuscular disease.

结局指标

主要结局

to compare the incidence of sore throat

时间窗: to compare the incidence of sore throat within 24 hours

次要结局

  • To compare the sensitivity of sore throat(To compare the duration of sore throat)

研究者

申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Mohammad Fariduddin Malik

Department of Anaesthesiology and Critical care JNMC AMU Aligarh UTTAR PRADESH

研究点 (1)

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