Comparison of nebulized Dexmedetomidine vs Magnesium Sulphate for the attenuation of postoperative sore throat in patients undergoing general anaesthesia
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 206
- 试验地点
- 1
- 主要终点
- To compare the incidence of the sore throat, hoarseness of voice and cough in the postoperative period in patients prophylactically treated with Dexmedetomidine or Magnesium Sulphate undergoing elective surgeries under general anaesthesia with tracheal intubation
研究概览
简要总结
Postoperative sore throat (POST) is a common complication following surgeries performed under general anaesthesia. The incidence of POST in patients undergoing tracheal intubation for general anaesthesia (GA) is 6.6-90 percentage. It is a double-blind randomized controlled trial to compare the effects of Dexmedetomidine and Magnesium Sulphate nebulisations on attenuation of sore throat, hoarseness of voice and cough in the postoperative period in patients undergoing elective surgeries under general anaesthesia with tracheal intubation. Patients fulfilling the inclusion criteria will be enrolled in the study and assessed prior to surgery. Predisposing factors such as cigarette smoking, gastroesophageal reflux disease, long-term use of corticosteroids and non-steroidal anti-inflammatory drugs will be captured. Patients will be informed about the study and informed consent will be obtained.
Participants will be randomly allocated into two groups using the fishbowl technique.One group will receive Dexmedetomidine at a dose of 1 mcg/kg, while the other group will receive 250 mg of Magnesium Sulphate. Dexmedetomidine (brand name: Dexem) and Magnesium Sulphate (brand name: Magneon) are available in the form of intravenous injection solutions, supplied in ampoules. They are diluted with normal saline for use via nebulisation. Both will be diluted with normal saline to a 5 mL solution in a 5 cc syringe and administered by a trained anaesthetist through a nebulization mask connected to wall-mounted, oxygen driven source (8 L/min, 50 psi) for 15 min. General anaesthesia (GA) will be induced after completing nebulization. Sore throat, hoarseness of voice, cough, haemodynamic parameters and respiratory rate will be measured at 0, 2, 4 and 6 hours from the time of extubation. POST would be graded on a four-point scale (0–3). This study seeks in formulating interventions for decreasing sore throat, cough and hoarseness of voice in the postoperative period that would help to improve the quality of postoperative recovery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant, Investigator and Outcome Assessor 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-PS I-II
- •Posted for elective surgical procedures in supine position under general anaesthesia with endotracheal intubation 3.Duration of surgery : 2-5 hours.
排除标准
- •Patients who refuse or lack the capacity to give consent
- •History of preoperative sore throat, respiratory tract infection, chronic lung diseases
- •Known allergy to the study drug
- •Pregnancy
- •Anticipated difficult airway
- •BMI greater than 30 kg/m2
- •Patients undergoing oral, nasal, head and neck surgeries
- •Requiring more than one attempt at intubation.
结局指标
主要结局
To compare the incidence of the sore throat, hoarseness of voice and cough in the postoperative period in patients prophylactically treated with Dexmedetomidine or Magnesium Sulphate undergoing elective surgeries under general anaesthesia with tracheal intubation
时间窗: Postoperatively at 0, 2, 4 and 6 hours from the time of extubation
次要结局
- To compare the effects of nebulization of the study drugs on respiratory rate and hemodynamic parameters such as heart rate, systolic blood pressure, diastolic blood pressure, mean arterial pressure(Postoperatively at 0, 2, 4 and 6 hours from the time of extubation)
研究者
Dr Ashley Eapen
Believers Church Medical College Hospital