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
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Optic nerve sheath diameter (ONSD) in both the groups at T0, T1, T5 and T10
Overview
Brief Summary
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
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Optic nerve sheath diameter (ONSD) in both the groups at T0, T1, T5 and T10
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Secondary Outcomes
- 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)
Investigators
Ayush singh
ABVIMS and Dr. Rml hospital,New Delhi