Dose Responsive Study of Ringer's Lactate Solution in Prevention of Post-induction Hypotension

Study Overview
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Brief Summary
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To assess the dose responsiveness of ringer lactate solution in prevention of post-induction hypotension predicted by Ultrasound guided Inferior Vena Cava diameter in patients receiving General anesthesia. OBJECTIVES Primary - To find the optimum preloading dosage of Ringer Lactate to prevent post induction hypotension. Secondary - To find the predictive incidence of Post-induction hypotension according to age, gender, type of surgery and comorbidities.

Detailed Description
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All patients, after Ultrasonographic Inferior vena cava collapsibility index calculation, will receive Lactated Ringer's solution as per body weight and as per their allocated group in the receiving area. After induction inside the Operating Room, All patients will be monitored continuously using Electrocardiography, pulse oximetry, noninvasive Blood pressure measurement and capnography . Heart rate, Systolic - Diastolic - Mean blood pressure, Oxygen saturation will be monitored as follows : Baseline parameters - Prior to administration of intravenous Ringer's lactate solution T0 (after administration of intravenous Ringer's lactate solution but prior to induction of anaesthesia), T1-T10 (every minute for first 10 mins after induction of anaesthesia) Our institutional standard practice of induction of Anaesthesia with Fentanyl (2 μg/kg), Propofol (2 mg/kg) and Vecuronium (0.1mg/kg ) will be followed and intubation will be done only after first 10 mins post induction. Amount of Mephentermine needed to correct hypotension despite RL infusion will also be calculated.

Official Title
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Dose Responsive Study of Ringer's Lactate Solution in Prevention of Post-induction Hypotension Predicted by Inferior Vena Cava Collapsibility Index in Patients Receiving General Anesthesia

Conditions
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Post Induction Hypotension

Intervention / Treatment
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* Other: RL 10ml/kg
* Other: RL 15ml/kg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years American Society of Anesthesiologists (ASA) Physical status classification system group I and II Elective surgery under General anesthesia Exclusion Criteria: Age <18 and > 65 American Society of Anesthesiologists (ASA) Physical status classification system group III and IV Systolic blood pressure ≥ 180 mmHg Systolic blood pressure < 90 mmHg Pregnant women Patients with abdominal mass or ascites Emergency surgery

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: RL 10<br>Patients of this group will receive Ringer's lactate (RL) 10ml/kg | Other: RL 10ml/kg<br>* Inferior vena cava collapsibility index of all patients will be calculated by ultrasonography and if it is >50%, then patients of this group (Group 1) will receive Ringer's lactate 10ml/kg before induction in the receiving area<br>|
| Active Comparator: RL 15<br>Patients of this group will receive 15ml/kg of Ringer's lactate solution | Other: RL 15ml/kg<br>* Inferior vena cava collapsibility index of all patients will be calculated by ultrasonography and if it is >50%, then patients of this group (Group 2) will receive Ringer's lactate 15ml/kg before induction in the receiving area<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effective dose of Ringer's lactate solution to prevent post-induction hypotension | This study will try to find out the effective dose of Ringer's lactate solution in ml/Kg that will prevent hypotension after induction of anaesthesia in study population | 15 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of age, gender, types of surgery and comorbid conditions on post-induction hypotension | This study will try to find out the effect of age, gender, type of surgery and type of comorbid conditions (like Diabetes, Hypertension etc) on occurence of post-induction hypotension by measuring the % of hypotension in these categories of patients | 15 months |