comparative evaluation of intravenous hydrocortisone and intravenous tranexamic acid for post operative sore throat in patients undergoing general anaesthesia with endotracheal intubation for elective surgeries: A double blind randomized controlled trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- 1. incidence and severity of post operative sore throat
研究概览
简要总结
Post operative sore throat is a common complication following general anesthesia and endotracheal intubation which can lead to significant discomfort in patients and delay in returning to their normal daily activities. The tracheal mucosa has been observed to release inflammatory mediators after intubation suggesting that the aetiology for postoperative sore throat is likely an inflammatory process.
Tranexamic acid is a synthetic lysine analogue that inhibits the proteolytic action of plasmin on fibrin clots and platelet receptors thereby inhibiting fibrinolysis. It is widely used to treat various diseases such as leukaemia hypermenorrhoea and haemophilia and for prevention of blood loss during surgery or acute trauma. Besides its haemostatic effect tranexamic acid is also applied in mucocutaneous diseases such as tonsillitis angioedema stomatitis and urticaria. Therefore it is sometimes prescribed with cold medicine including pharyngitis in Japan.
Tranexamic acid is a synthetic lysine analogue that inhibits the proteolytic action of plasmin on fibrin clots and platelet receptors thereby inhibiting fibrinolysis. It is widely used to treat various diseases such as leukaemia hypermenorrhoea and haemophilia and for prevention of blood loss during surgery or acute trauma. Besides its haemostatic effect tranexamic acid is also applied in mucocutaneous diseases such as tonsillitis angioedema stomatitis and urticaria. Therefore it is sometimes prescribed with cold medicine including pharyngitis in Japan.
In a recent study done by Okholm et al. they have found that tranexamic acid might modulate the inflammatory response by enhancing or inhibiting the levels of cytokines.in their study they found that anti inflammatory effect of TXA was consistent in orthopaedic patients however they found no inflammatory effect of TXA in patients undergoing cardiac or paediatric surgeries.
Corticosteroids are known for their potent anti inflammatory effects whatever the source of the inflammation is i.e. infection chemical or physical damage or immune deficiency36 hence it was hypothesized that anti inflammatory characteristics of hydrocortisone may prevent postoperative sore throat or decrease its severity.] However in a study conducted by Eydi M et al. they found no effect of intravenous hydrocortisone on incidence and severity of post operative sore throat. In another study done by Bergeson K et al. they concluded that use of single dose of corticosteroid can alleviate pain and even decrease the requirement of antibiotics in patients suffering from severe or exudative sore throat.
In present study we want to compare the effect of intravenous hydrocortisone and intravenous tranexamic acid on incidence and severity of postoperative sore throat in patients undergoing general anaesthesia with endotracheal intubation for elective surgeries.
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
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •ASA grade I and II
- •Age between 20 to 60 years
- •Patients undergoing surgeries under general anaesthesia with tracheal intubations
- •Surgeries lasting 1 to 3 hours.
排除标准
- •Patient refusal.
- •Patient with known allergy to drug
- •Patients with IHD, valvular heart disease.
- •Patients with history of or with risk factors for thromboembolism.
- •Patients with renal dysfunction.
- •Patients with elevated AST, ALT values.
- •Patients undergoing surgeries under general anaesthesia with supraglottic airway devices.
- •Patients already taking tranexamic acid or hydrocortisone (or other steroids) for any other indication.
- •History of convulsions .
结局指标
主要结局
1. incidence and severity of post operative sore throat
时间窗: 2 hours | 4 hours | 6 hours | 12 hours | 24 hours
次要结局
- has sore throat affected your ability to eat or drink(2 hours)
研究者
DR OM PRAKASH ADITYA
RAIPUR INSTITUTE OF MEDICAL SCIENCES