Effects of Pace of Endotracheal Tube Cuff Deflation On Cough Reflex During Extubation In Patients Undergoing Middle Ear Surgery:A Randomised Control Trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Incidence of cough reflex during extubation
研究概览
简要总结
This study is to assess the incidence and severity of cough reflex after continuously and slowly deflating endotracheal tube cuff at a rate of 1ml/second compared to rapid deflation during extubation in patients undergoing middle ear surgeries.
A randomised controlled trial will be conducted over a period of 1 year and 6 months on 76 patients of ASA I-II status, in the age group of 18-65 years undergoing middle ear surgery .All patients will be subjected to preanesthetic evaluation ,the study will be explained in detail and written informed consent will be obtained.
Patients enrolled for this study will be randomised into two groups of 38 each, using computer generated random numbers .Before induction of anaesthesia, the opaque envelope containing group allocation is opened and the group to which that patient is allotted will be determined.
Patient will be induced with Injection Fentanyl 2 mcg/kg ,Propofol 2 mg/kg. Laryngoscopy and endotracheal intubation will be done .The endotracheal tube cuff is inflated with 5-8 ml air and cuff pressure is maintained 25-30 cm of H2O . Anaesthesia will be maintained with oxygen,air and sevoflurane.
During extubation ,cuff is deflated as follows,
Group A-Deflation at a rate of 1ml/second
Group B-Rapid deflation
The incidence and severity of cough reflex using numerical scoring system at extubation and hemodynamic changes during extubation at 1min,5 min and 10 min will be assessed.Data will be summerised by using descriptive statistics.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •ASA physical status I or II Patients undergoing middle ear surgeries under general anaesthesia Duration of surgery more than 1 hour and less than 6 hours.
排除标准
- •Body mass index < 19 kg/m2 or > 30 kg/m2 Mallampati classification III or IV Pre existing sore throat,hoarseness,cough or laryngeal mucosal haemorrhage More than one attempt at intubation during induction Delayed emergence (inability to regain an adequate level of counsciousness ,unresponsive or deeply sedated over 60 min from the last administration of anaesthetic agents) Asthma ,chronic obstructive pulmonary disease ,smoking ,anxiety disorder.
结局指标
主要结局
Incidence of cough reflex during extubation
时间窗: During extubation
次要结局
- Severity of cough reflex & hemodynamic changes during cuff deflation(During extubation)