Impact of dividing the dose of sugammadex on reducing emergence cough - A prospective, randomized, double-blinded study
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- To measure and compare the incidence and severity of emergence cough between two groups of patients:
研究概览
简要总结
Sugammadex is a modified gamma cyclodextrin which selectively binds to the aminosteroid class of non-depolarizing neuromuscular blocking agents, with the highest affinity for encapsulating rocuronium. It has been studied extensively and emerged as a superior reversal agent. Despite it’s safe clinical profile, the most common adverse reaction with sugammadex reversal is emergence cough. In anaesthesia, it is desirable to avoid sudden cough on emergence as it is associated with several adverse outcomes. In our study, we aim to demonstrate a reduction in the incidence and severity of emergence cough by dividing the dose of sugammadex, which will help us improve post-operative clinical outcomes.
Our study is a Randomized, double-blinded, prospective, single centre study, where our primary outcome is to measure and compare the incidence and severity of emergence cough between two groups of patients:
1. One group (A) receiving the total dose of sugammadex (2 mg/kg) prior to extubation, and
2. The other group (B) receiving half of the total 2 mg/kg dose (1 mg/kg) before, and the remaining half (1 mg/kg) immediately after extubation.
We will also measure and compare secondary outcomes such as any incidence of post-extubation desaturation (oxygen saturation less than 90% on facemask), post-extubation sedation levels graded with Ramsay Sedation Score (RSS), any severe delayed post-operative cough and post-operative sore throat between the two groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •American Society of Anesthesiologists (ASA) physical status 1 – 3
- •Body mass index (BMI) less than 35kg/m2
- •Scheduled to undergo elective surgery under general anaesthesia with endotracheal intubation.
排除标准
- •Patient refusal
- •Past history of allergy
- •History of neuromuscular disease, coagulopathy
- •Patients with severe hepatic or renal impairment
- •Haemodynamically unstable patients
- •Patients who are planned to remain intubated and mechanically ventilated or tracheostomized postoperatively
- •Pregnant or lactating women
- •History of asthma or chronic obstructive pulmonary disease
- •Difficult intubation requiring more than 3 attempts.
结局指标
主要结局
To measure and compare the incidence and severity of emergence cough between two groups of patients:
时间窗: 1. Emergence time (time period from discontinuation of all anaesthetic agents to administration of intravenous reversal agent sugammadex) | 2. Extubation time (time period from intravenous administration of reversal agent sugammadex to the time at which tracheal extubation is performed) | 3. 1 minute after extubation | 4. 5 minutes after extubation | 5. 60 minutes in the Post Anaesthesia Care Unit (PACU).
1. One group (A) receiving the total dose of sugammadex (2 mg/kg) intravenous over 10 seconds prior to extubation, and
时间窗: 1. Emergence time (time period from discontinuation of all anaesthetic agents to administration of intravenous reversal agent sugammadex) | 2. Extubation time (time period from intravenous administration of reversal agent sugammadex to the time at which tracheal extubation is performed) | 3. 1 minute after extubation | 4. 5 minutes after extubation | 5. 60 minutes in the Post Anaesthesia Care Unit (PACU).
2. The other group (B) receiving half of the total 2 mg/kg dose (1 mg/kg intravenous over 10 seconds) before extubation, and the remaining half (1 mg/kg intravenous over 10 seconds) immediately after extubation.
时间窗: 1. Emergence time (time period from discontinuation of all anaesthetic agents to administration of intravenous reversal agent sugammadex) | 2. Extubation time (time period from intravenous administration of reversal agent sugammadex to the time at which tracheal extubation is performed) | 3. 1 minute after extubation | 4. 5 minutes after extubation | 5. 60 minutes in the Post Anaesthesia Care Unit (PACU).
次要结局
- Incidence of post-operative sore throat(60 minutes in the Post Anaesthesia Care Unit (PACU))
- To measure & compare post-extubation sedation levels graded with Ramsay Sedation Score (RSS).(1. 1 minute after extubation)
- To measure & compare the incidence of post-extubation desaturation (oxygen saturation less than 90% on facemask) between the two groups(1. 1 minute after extubation)
- Incidence of severe delayed post-operative cough(60 minutes in the Post Anaesthesia Care Unit (PACU))