Comparison of I-gel vs LMA Proseal as airway for laproscopic hernioplasty
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
- a)To compare two supraglottic devices I gel vs LMA Proseal in terms of respiratory mechanics during positive pressure ventilation in laproscopic hernioplasty
研究概览
简要总结
This is a prospective randomized controlled study which will be conducted on 60 patients who are within the decided inclusion criterias. 60 patients will be then randomly allotted in two groups GROUP I and GROUP P of 30 each by computer based randomized system. Patients will be premedicated with inj glycopyrrolate 0.2mg i.m, in fortwin 0.6mg/kg i.m. In operation theatre, inj midazolam 1mg i.v will be given and basal reading of HR, SBP, DBP, Oxygen saturation, will be noted. After induction with inj propofol 3mg/kg i.v , with loss of eyelash reflex, inj rocuronium 0.9mg/kg will be administered. After mask ventilation for 1 minute appropriate size airway device according to the group which patient belongs, will be inserted. Effective ventilation with the device will be defined as bilateral equal chest movements and normal capnograph. Hemodynamic readings will be taken at 1,3,5,7,10,15minutes after insertion of device . Insertion attempts and ease of insertion will be noted. More than two intertions attempts will be considered as a failure and that patient will be excluded from the study and patient will be intubated conventionally. IPPV will be given to maintain EtCO2 between 30-45mm hg. Patient will be maintained on oxygen, nitrous oxide, isoflurane, and intermittent inj vecuronium iv. Ryle’s tube will be inserted through the device and its ease of insertion and number of attempts will be noted. Oxygen saturation, EtCO2 , airway pressure, inhaled tidal volume, exhaled tidal volume, minute ventilation is noted before, and after ten minutes of CO2 insuffation and 10minutes after release of CO2. After surgery patient will be reversed with inj neostigmine 0.05mg/kg i.v and inj. Glycopyrrolate 0.008mg/kg i.v. After patient is conscious and follows verbal command patient will be transferred to post operative recovery room.
Complications such as incidence of cough, laryngospasm, blood on device, lip and dental trauma will be noted.
Each patient will be questioned after 12hrs of surgery regarding sore throat, dysphagia, dysphonia, numbness over tongue or oropharynx.
Mean and SD will be calculated and data will be analysed using paired t-test using EPI software.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •body weight 40-60kgs.
排除标准
- •Obese patients,known difficult airway, mouth opening <2.5 fingers, cervical spine disease, patients prone to aspiration such as hiatus hernia and GERD and emergency surgeries.
- •Patients with systemic illness.Those patients who does not give consent to be part of the study are excluded from the study.
结局指标
主要结局
a)To compare two supraglottic devices I gel vs LMA Proseal in terms of respiratory mechanics during positive pressure ventilation in laproscopic hernioplasty
时间窗: peak airway pressure, inhaled tidal volume, exhaled tidal volume, leak, minute ventilation, etco2 will be recorded 10 mins after placement of device, 10 mins after carboperitonium, 10mins after release of co2.
b)To study and compare two devices for ease of insertion and effectiveness of insertion.
时间窗: peak airway pressure, inhaled tidal volume, exhaled tidal volume, leak, minute ventilation, etco2 will be recorded 10 mins after placement of device, 10 mins after carboperitonium, 10mins after release of co2.
次要结局
- a)To study the hemodynamic parameters with the above two devices in laproscopic hernia(b)Study adverse events in the group in form of trauma to airway and post operative sore throat and other complications.)