A COMPARATIVE EVALUATION BETWEEN I-GEL AND PROSEAL LARYNGEAL MASK AIRWAY FOR OROPHARYNGEAL LEAK PRESSURE IN PATIENTS UNDERGOING SURGERY UNDER GENERAL ANAESTHESIA - A PROSPECTIVE RANDOMISED CLINICAL STUDY
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Oropharyngeal Leak Pressure
研究概览
简要总结
TITLE OF THESIS: A COMPARATIVE EVALUATION BETWEEN I-GEL AND PROSEAL LARYNGEAL MASK AIRWAY FOR OROPHARYNGEAL LEAK PRESSURE IN PATIENTS UNDERGOING SURGERY UNDER GENERAL ANAESTHESIA - A PROSPECTIVE RANDOMISED CLINICAL STUDY
ANAESTHETIC PROCEDURE: In the operating room, standard monitoring including ECG, pulse oximetry, non-invasive BP, end-tidal carbon dioxide will be attached. Intravenous(iv) access with be secured. Anaesthetic technique shall comprise of a uniform pre-medication with Inj.Glycopyrolate 0.01 mg/kg iv, Inj.Midazolam 0.03 mg/kg iv, Inj.Fentanyl 1.5mcg/kg iv and Inj.Dexamethasone 0.1 mg/kg iv. All these drugs will be given intravenously 15 minutes prior to transfer of the patient to operating room. After preoxygenation with 100% Oxygen for 3 min, anaesthesia will be induced with Inj.Propofol 2 mg/kg iv. After adequate muscle relaxation with Inj.Vecuronium 0.1mg/kg, supraglottic airway devices will be inserted depending on the group to which the patient is assigned. Now the device will be attached to circuit system and anaesthesia will be maintained with 60% Nitrous Oxide in Oxygen with Vecuronium Bromide and Isoflurane(0.5%).After preoxygenation with 100% Oxygen for 3 min, anaesthesia will be induced with Inj.Propofol 2 mg/kg iv. After adequate muscle relaxation with Inj.Vecuronium 0.1mg/kg, supraglottic airway devices will be inserted depending on the group to which the patient is assigned. Now the device will be attached to circuit system and anaesthesia will be maintained with 60% Nitrous Oxide in Oxygen with Vecuronium Bromide and Isoflurane(0.5%).
-
Oropharyngeal Leak Pressure:
-
Time of insertion of the study device:
-
Number of attempts for placement of device (1/2/F):
-
Laryngeal view score/grade:
Grade I “full view of the glottis” (Full) - POGO 100%
Grade II “posterior commissure” (Partial) - POGO 50%
Grade III “only arytenoids” (None) - POGO 0%
- Ease of insertion of device:
Grade I:
Grade II:
Grade III:
- Changes in heart rate and mean arterial pressure following
insertion and removal of device:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 20.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •ASA Grade: I and II Weight: 30 to 70 kg MP Grade: I to IV.
排除标准
- •Any pathology of the oral cavity that may obstruct the insertion of devices.
- •Mouth opening less than 2.5 cm.
- •Expected during of surgery longer than 2 hours.
- •Potentially full stomach patients (trauma, morbid obesity, pregnancy, history of gastric regurgitation and heart burn) and at risk of esophageal reflux (hiatus hernia).
- •Bleeding disorders.
- •Lack of consent to participate in the study.
结局指标
主要结局
Oropharyngeal Leak Pressure
时间窗: Oropharyngeal Leak Pressure at the time of insertion and after 10 min of insertion
次要结局
- Time of insertion of the study device(Time taken to insert the study device after induction)
- Number of attempts for placement of study device (1/2/F)(Time taken to insert the study device after induction)
- Laryngeal view score/grade using POGO score(POGO score (0%, 33%, 100%))
- Ease of insertion of study device(Number of adjustment manoeuvers (1, 2, 3))
- Changes in heart rate and mean arterial pressure following insertion and removal of device.
- Complications(Trauma of lip, tougue, pharynx)
研究者
DR MOHAMMAD NAUSHAD ALAM
JAWAHARLAL NEHRU MEDICAL COLLEGE, ALIGARH MUSLIM UNIVERSITY, ALIGARH