Efficacy of intraoperative magnesium sulphate and vitamin C in prevention of postoperative sore throat following endotracheal intubation
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Severity of postoperative sore throat
研究概览
简要总结
All patients will be subjected to the pre-anaesthetic assessment prior to enrollment in the study. Their detailed medical and surgical history will be taken along with any previous anaesthetic exposure with its outcome. A thorough airway, systemic examination will also be done. The routine investigations will be done for all patients. All patients scheduled for surgery will be kept fasting for at least 6 hours prior to surgery.
Randomization will be done by computer generated random numbers. Neither the investigators not the patients will know about the study drug and the code will be broken after the completion of study. The selected patients will be randomly allocated to one of the following three groups:
Group I (n=30)- patients receiving intravenous magnesium sulphate
Group II (n=30)- patients receiving intravenous vitamin C
Group III (n=30)- patients receiving normal saline
After informed consent, patient will be transferred to operating room, standard monitors (ECG, NIBP, SpO2) will be attached. After induction of anaesthesia as per standard protocol, patients will be given one of study drug ( magnesium sulfate, vitamin C, Normal saline) by the resident who is not further involved in study. Magnesium sulfate 1 gram intravenous, vitamin C 2 gram intravenous and 100 ml normal saline over 30 minutes after induction. At the end of surgery injection paracetamol 1g intravenous will be given to all patients . After completion of surgery and emergence from general anaesthesia, patients will be transferred to post anesthesia care unit (PACU). Once in PACU, patients will be assessed for postoperative sore throat using a standardized scale. The severity of POST will be graded on a 4- point scale ranging from 0-3; 0 being no sore throat, 1 being mild sore throat ( complain only upon questioning), 2 being moderate sore throat ( complain on his/her own), 3 being severe sore throat ( change in voice , hoarseness, throat pain). This evaluation will be performed at 0 h, 6 hours, 12 hours and 24 hours postoperatively. Any side effects occuring will be noted.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 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
- •Patients in age group between 18 to 60 years of either sex, belonging to American Society of Anaesthesiologists (ASA) physical status I and II will be included in the study who will undergo general anaesthesia with placement of endotracheal tube.
排除标准
- •Unwillingness of patient, history of preoperative sore throat,any recent use of anti-inflammatory drugs, major hepatic,renal, cardiovascular,respiratory and neuromuscular disease, duration of surgery more than 3 hours, attempts of endotracheal intubation more than one, pregnant and lactating women, previous history of allergy to study drug, anticipated difficult airway.
结局指标
主要结局
Severity of postoperative sore throat
时间窗: At 0 h, 6 hours, 12 hours and 24 hours postoperatively
次要结局
- Side effects if any(At 0, 6 hours, 12 hours and 24 hours postoperatively)