Effect of Proseal laryngeal mask airway and igel on ultrasound guided changes in optic nerve sheath diameter in hypertensive patients undergoing general anaesthesia:A randomised comparative study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Optic nerve sheath diameter (ONSD) in both the groups at T0, T1, T5 and T10
研究概览
简要总结
The group
will be divided into Group P or in the Group I.
Group P-people in which we will introduce ProSeal as a supraglottic airway device (SAD) after induction
Group I-people in which we will introduce I-gel as a supraglottic airway device (SAD) after induction
Preoperative anaesthetic examination will be done and patient will be advised to keep
fasting 6 hours for solids and 2 hours of clear liquid prior to the surgery.
Upon arrival in the operating room, standard ASA monitor will be attached. T0 ONSD will be measured for the baseline value. I.V. cannula will be secured and Pre-oxygenation with 100% oxygen will be done for 3 minutes. Premedication with injection Midaz 1mg and fentanyl 2 mcg/kg will be given and all patients will undergo induction of general anaesthesia (GA) using intravenous induction with propofol 2 mg/kg and vecuronium 100 mcg/kg. Bag and mask will be done for 3 minutes with Oxygen: Air 50:50 and Sevoflurane to maintain the MAC of 1-1.2
After 3 minutes, we will introduce ProSeal/I-gel of correct size w.r.t the allotted group P/I and will fix the device.
After securing the airway, patient will be kept on VCV (volume-controlled ventilation) mode with Tidal volume-8-10 ml/kg Respiratory Rate-12/minute and PEEP-5 cm H2O to maintain EtCO2 of 35-40mmHg with Oxygen: Air 50:50 and Sevoflurane to maintain the MAC of 1
Then we will observe the ONSD value at T1, T5 and T10 minutes after 1,5 and 10 minutes after securing the airway and before incision.
Surgical incision will be given after obtaining T10 value
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •American society of Anaesthesiologists (ASA) grade II/III patients aged 18-65 years.
- •Hypertensive patients undergoing elective surgery under general anaesthesia.Mallampati class (MPG) I and II.
排除标准
- •Anticipated difficult airway.Any ophthalmic injury.Optic nerve pathology.Body mass index greater than 30.History of cerebral vascular accidents.History of head injury.History of any neurological disorder.History of ophthalmic surgery or neurosurgery.
结局指标
主要结局
Optic nerve sheath diameter (ONSD) in both the groups at T0, T1, T5 and T10
时间窗: Optic nerve sheath diameter (ONSD) in both the groups at T0, T1, T5 and T10 | 1. Baseline ONSD value before induction (T0) | 2. ONSD value after 1 minute inserting ProSeal LMA/I-Gel (T1) | 3. ONSD value after 5 minutes inserting ProSeal LMA/I-Gel (T5) | 4. ONSD value after 10 minutes inserting ProSeal LMA/I-Gel (T10)
1. Baseline ONSD value before induction (T0)
时间窗: Optic nerve sheath diameter (ONSD) in both the groups at T0, T1, T5 and T10 | 1. Baseline ONSD value before induction (T0) | 2. ONSD value after 1 minute inserting ProSeal LMA/I-Gel (T1) | 3. ONSD value after 5 minutes inserting ProSeal LMA/I-Gel (T5) | 4. ONSD value after 10 minutes inserting ProSeal LMA/I-Gel (T10)
2. ONSD value after 1 minute inserting ProSeal LMA/I-Gel (T1)
时间窗: Optic nerve sheath diameter (ONSD) in both the groups at T0, T1, T5 and T10 | 1. Baseline ONSD value before induction (T0) | 2. ONSD value after 1 minute inserting ProSeal LMA/I-Gel (T1) | 3. ONSD value after 5 minutes inserting ProSeal LMA/I-Gel (T5) | 4. ONSD value after 10 minutes inserting ProSeal LMA/I-Gel (T10)
3. ONSD value after 5 minutes inserting ProSeal LMA/I-Gel (T5)
时间窗: Optic nerve sheath diameter (ONSD) in both the groups at T0, T1, T5 and T10 | 1. Baseline ONSD value before induction (T0) | 2. ONSD value after 1 minute inserting ProSeal LMA/I-Gel (T1) | 3. ONSD value after 5 minutes inserting ProSeal LMA/I-Gel (T5) | 4. ONSD value after 10 minutes inserting ProSeal LMA/I-Gel (T10)
4. ONSD value after 10 minutes inserting ProSeal LMA/I-Gel (T10)
时间窗: Optic nerve sheath diameter (ONSD) in both the groups at T0, T1, T5 and T10 | 1. Baseline ONSD value before induction (T0) | 2. ONSD value after 1 minute inserting ProSeal LMA/I-Gel (T1) | 3. ONSD value after 5 minutes inserting ProSeal LMA/I-Gel (T5) | 4. ONSD value after 10 minutes inserting ProSeal LMA/I-Gel (T10)
次要结局
- 1. Hemodynamic response (SBP, DBP, MAP & HR) in both the groups at T0, T1, T5 & T10(2. Co-relation of hemodynamic changes with changes in ONSD at T0, T1, T5 & T10)
研究者
Ayush singh
ABVIMS and Dr. Rml hospital,New Delhi