Comparative evaluation of two second generation supraglottic airway devices in adult patients undergoing elective surgery under general anaesthesia.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Oropharyngeal leak pressure
研究概览
简要总结
This prospective randomised study has been designed to evaluate and compare the clinical efficacy of LMA Protector with i-gel as a ventilatory device in adult patients undergoing elective surgery under general anesthesia with controlled ventilation.
We hypothesise that Laryngeal Mask Airway Protector will have a better clinical efficacy as a ventilatory device as compared to i-gel in terms of higher oropharyngeal leak pressure in adult patients undergoing elective surgery under general anaesthesia with controlled ventilation.
This study will be conducted in 100 adult patients of either gender, in age group of 18 to 60 years, weighing 30- 70 Kg, American society of Anaesthesiologists (ASA) physical status I and II undergoing elective surgery under general anaesthesia with controlled ventilation in supine position.
Patients will be randomly allocated to two groups of 50 each.
Group I- i- gel will be inserted in the patients (n= 50)
Group P- LMA Protector will be inserted in the patients(n= 50)
Computer generated random number table will be used to allocate patients to two groups. Allocation will be concealed in sequentially numbered sealed opaque envelopes. Once a patient gives consent to enter the study, an envelope will be opened and the patient will then be offered the allocated group.
Preanaesthetic evaluation of the patient will be done ,those falling under exclusion criteria will be excluded, written informed consent will be taken from the patient
Patient will be taken to operation theatre . Baseline vitals noted
preoxygenation for 3 minutes with 100% oxygen
Induction with Fentanyl 2 μ/kg, Propofol 2-2.5mg/kg followed by vecuronium 0.1mg/kg
Face mask ventilation with Isoflurane (1-1.5%) in 50 % oxygen and 50% nitrous oxide for 3 minutes
Group P- LMA - Protector inserted n=50
Group I- i- gel inserted n=50
Confirmation of achieving effective ventilation and correct gastric catheter insertion
Parameters to be noted
1.Oropharyngeal seal pressure 2 .Insertion characteristics-Number of attempts taken for successful insertion of device, time for achieving effective ventilation, ease of insertion of device, ease of gastric catheter insertion 3.Anatomical alignment of device to glottic opening
Postoperative pharyngolaryngeal morbidity noted
Primary objective is to compare Laryngeal Mask Airway Protector with i-gel in terms of oropharyngeal leak pressure in adult patients undergoing elective surgery under general anaesthesia with controlled ventilation.
SECONDARY OBJECTIVES:
To compare following insertion characteristics of Laryngeal Mask Airway Protector with i-gel in adult patients undergoing elective surgery under general anaesthesia with controlled ventilation:
-Number of attempts taken for successful insertion of device,
-Time for achieving effective ventilation,
-Ease of insertion of device,
-Ease of gastric catheter insertion
-Fibreoptic bronchoscopic score regarding anatomical alignment of device
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 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with ASA physical status grade 1 and 2 undergoing elective surgery under general anaesthesia with controlled ventilation in supine position.
排除标准
- •Patients with anticipated difficult airway including: Thyromental distance <6.5 cm, Upper lip bite test class >1, Mallampatti class III and IV, Restricted head and neck mobility, Mouth opening <3.5 cm, BMI>30 kg/m2 2) Cervical spine pathology 3) Intestinal and oesophageal pathology 4) Operation time greater than 4 hours 5) High risk of aspiration 6) Preoperative sore throat 7) Poor dentition with high risk of damage 8) Pregnancy.
结局指标
主要结局
Oropharyngeal leak pressure
时间窗: 1. within 5 minutes after device insertion | 2. At 30 minutes after device insertion
次要结局
- number of attempts taken for successful insertion of device, time for achieving effective ventilation , number of patients requiring manipulation for achieving effective ventilation and type of manipulation , ease of insertion of device , ease of gastric catheter insertion, score regarding anatomical alignment of device(at the time of device insertion)