Comparing the Effect of Ketamine and Magnesium Sulfate Gargling With Placebo on Post-operative Sore Throat: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- severity of post-operative sore throat
研究概览
简要总结
A prospective randomized double-blind study including patients ASA I-II, aged more than 18 years undergoing surgery under general anesthesia (GA) and endotracheal intubation. Patients were randomized allocated into 2 groups: ketamine group received ketamine gargle (0.5 mg/kg up to 30 ml dextrose water) and magnesium group received magnesium sulfate gargle (20 mg/kg up to 30 mL dextrose water ) 15 minutes before the operation.
Our primary outcome is sore throat and the secondary judging criteria are cough, dysphonia and satisfaction. A standardized anesthesia protocol was followed for all patients. After extubation, the patients were asked to grade POST, hoarseness, and cough at 15 min, 1h, and 24 h.
详细描述
This is a prospective, single-center, randomized, double-blind study. the investigators included in the study the patients:
whose age is greater than or equal to 18 years; ASA class 1 or 2, proposed for elective visceral, orthopedic, oncology, ophthalmologic, urologic surgery under general anesthesia with orothracheal intubation, expected duration ≤ 120 min.
the non-inclusion criteria are known allergy to ketamine or maguisuim sulphate, ASA 3 and more, cervical surgery; rapid sequence induction, difficult intubation planned or history of difficult intubation, malformation of the O.R.L sphere; upper respiratory tract infections. the need for multiple laryngoscopies for orotracheal intubation (≥ 2 attempts); the need for a postoperative nasogastric tube.
randomization is performed upon entering the operating room. The gargle allocation scheme, Ketamine Group or Magnesium Sulfate Group was randomly generated using a randomization table with an allocation ratio of 1: 1.
Postoperative follow-up was carried out in the post-intervention monitoring room then in hospitalization within the various referring services (general surgery, orthopedics, O.R.L and ophthalmology).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age is greater than or equal to 18 years
- •ASA class 1 or 2
- •patients proposed for elective visceral, orthopedic, oncology, ophthalmologic, urologic surgery under general anesthesia with orothracheal intubation
排除标准
- •known allergy to ketamine or maguisuim sulphate
- •ASA 3 and more
- •cervical surgery
- •difficult intubation planned or history of difficult intubation
- •malformation of the O.R.L sphere
- •the need for multiple laryngoscopies for orotracheal intubation (≥ 2 attempts);
- •the need for a postoperative nasogastric tube.
研究组 & 干预措施
ketamine group
ketamine gargle (0.5 mg/kg up to 30 ml dextrose water) 15 minutes before the operation
干预措施: Magnesium sulfate versus ketamine (Drug)
magnesium sulfate group
magnesium sulfate gargle (20 mg/kg up to 30 mL G5%) 15 minutes before the operation.
干预措施: Magnesium sulfate versus ketamine (Drug)
结局指标
主要结局
severity of post-operative sore throat
时间窗: at the twenty-fourth hour postoperatively
The severity of POST was scored on a three-point score from 0 to 2 (0 = No pain; 1 = Oropharyngeal pain on speaking; 2 = Spontaneous oropharyngeal pain)
次要结局
- Patient satisfaction(at the twenty-fourth hour postoperatively)
- the incidence of cough(at the twenty-fourth hour postoperatively)
研究者
Mechaal Benali
Professor
University Tunis El Manar