Ringer Lactate Preloading on Induction Dose Requirement of Propofol

Study Overview
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Brief Summary
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To compare the effect (heart rate and mean arterial pressure) of Ringer Lactate preloading and without preloading on induction dose requirement of Propofol. The Propofol requirement for induction dose with respect to loss of eyelash reflex in Ringer Lactate preloaded versus control group.

Detailed Description
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From the operation list, patients that meet the Inclusion criteria will be selected. (n=60) Patients will be allocated into two participant groups. Group I and Group II respectively using Simple random sampling technique by Ballot method. Ballot method is to keep the list of patients that meet the inclusion criteria in two ballot box mentioning name and groups and do the lottery based selection for both groups and Patient code will be given. Group I (n = 30) Preloading with Ringer Lactate 30 ml/kg over 30 mins prior to surgery will be done and Propofol dose (2mg / kg ) requirement for induction of anaesthesia will be noted. Group II (n = 30) No Preloading will be done and Propofol dose (2mg / kg) requirement for induction of anaesthesia will be noted. Then, investigators will visualize for loss of eyelash reflex in both groups. The hemodynamic response (heart rate, systolic blood pressure, diastolic blood pressure and mean arterial pressure) to intubation between the two participant groups will be noted. The total Propofol requirement for induction in Ringer Lactate preloaded versus control group will be recorded. Drug administration and parameters recording will be done by the anaesthesiologist / under supervision

Official Title
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Effect of Ringer Lactate Preloading on Induction Dose Requirement of Propofol and Its Haemodynamic Stability at a Tertiary Center

Conditions
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Anesthesia, Ringer's Lactate

Intervention / Treatment
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* Drug: Ringer Lactate prior to surgery and Propofol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients scheduled for elective surgeries American Society of Anaesthesiologists (ASA) class I patients Age between 18-45 years Any surgery under general anaesthesia requiring endotracheal intubation Body mass index (BMI) -18.5 - 24.9 Those providing written consent Exclusion Criteria: Emergency surgery Patients with multiple injuries, pregnancy Airway Mallampati grade II, III and IV Allergy to Ringer Lactate and Propofol.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group I (Preloading with Ringer Lactate)<br>Preloading with Ringer lactate 30ml/kg over 30 minutes prior to surgery and Propofol dose requirement for induction of anaesthesia will be noted | Drug: Ringer Lactate prior to surgery and Propofol<br>* Ringer Lactate prior to surgery and Propofol dose requirement for induction of anaesthesia will be noted<br>* Other names: Ringer Lactate group;|
| No Intervention: Group II (No preloading)<br>No preloading will be done and Propofol dose requirement for induction of anaesthesia will be noted | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Propofol dose Required (mg) | Propofol dose (mg) with aspect to weight (kg) | Standard dosing in Operation | 
| Total Propofol dose given (mg) | Propofol dose (mg) | Visualization of loss of eyelash reflex | 
| Loss of eyelash reflex (seconds) | Visualization of loss of eyelash reflex (seconds) | Propofol given till loss of eyelash reflex | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Units of Measure (e.g., weight and height) | Weight in kilograms, height in meters ( weight and height will be combined to report BMI in kg/m²). | Preanaesthetic checkup, Day 1 | 
| Heart rate (beats / minute): After IV Propofol | Heart rate (beats / minute) will be measured with pulse oxymeter | Immediately After IV Propofol | 
| Heart rate (beats / minute): Baseline before IV fluid infusion | Heart rate (beats / minute) will be measured with pulse oxymeter | Base line Before IV fluid infusion | 
| Heart rate (beats / minute): At intubation (0 minute) | Heart rate (beats / minute) will be measured with pulse oxymeter | At intubation (0 minute) | 
| Heart rate (beats / minute): Post intubation (1 minute) | Heart rate (beats / minute) will be measured with pulse oxymeter | Post intubation (1 minute) | 
| Heart rate (beats / minute): Post intubation (3 minute) | Heart rate (beats / minute) will be measured with pulse oxymeter | Post intubation (3 minute) | 
| Heart rate (beats / minute): Post intubation (5 minute) | Heart rate (beats / minute) will be measured with pulse oxymeter | Post intubation (5 minute) | 
| Heart rate (beats / minute): Post intubation (10 minute) | Heart rate (beats / minute) will be measured with pulse oxymeter | Post intubation (10 minute) | 
| Systolic blood pressure (mm Hg): Baseline before IV fluid infusion | Systolic blood pressure (mm Hg) will be recorded on vital monitor | Baseline before IV fluid infusion | 
| Systolic blood pressure (mm Hg): After IV Propofol | Systolic blood pressure (mm Hg) will be recorded on vital monitor | Immediately After IV Propofol | 
| Systolic blood pressure (mm Hg): At intubation (0 minute) | Systolic blood pressure (mm Hg) will be recorded on vital monitor | At intubation (0 minute) | 
| Systolic blood pressure (mm Hg): Post intubation (1 minute) | Systolic blood pressure (mm Hg) will be recorded on vital monitor | Post intubation (1 minute) | 
| Systolic blood pressure (mm Hg): Post intubation (3 minute) | Systolic blood pressure (mm Hg) will be recorded on vital monitor | Post intubation (3 minute) | 
| Systolic blood pressure (mm Hg): Post intubation (5 minute) | Systolic blood pressure (mm Hg) will be recorded on vital monitor | Post intubation (5 minute) | 
| Systolic blood pressure (mm Hg): Post intubation (10 minute) | Systolic blood pressure (mm Hg) will be recorded on vital monitor | Post intubation (10 minute) | 
| Diastolic blood pressure (mm Hg): Baseline before IV fluid infusion | Diastolic blood pressure (mm Hg) will be recorded on vital monitor | Baseline before IV fluid infusion | 
| Diastolic blood pressure (mm Hg): After IV Propofol | Diastolic blood pressure (mm Hg) will be recorded on vital monitor | Immediately After IV Propofol | 
| Diastolic blood pressure (mm Hg): At intubation (0 minute) | Diastolic blood pressure (mm Hg) will be recorded on vital monitor | At intubation (0 minute) | 
| Diastolic blood pressure (mm Hg): Post intubation (1 minute) | Diastolic blood pressure (mm Hg) will be recorded on vital monitor | Post intubation (1 minute) | 
| Diastolic blood pressure (mm Hg): Post intubation (3 minute) | Diastolic blood pressure (mm Hg) will be recorded on vital monitor | Post intubation (3 minute) | 
| Diastolic blood pressure (mm Hg): Post intubation (5 minute) | Diastolic blood pressure (mm Hg) will be recorded on vital monitor | Post intubation (5 minute) | 
| Diastolic blood pressure (mm Hg): Post intubation (10 minute) | Diastolic blood pressure (mm Hg) will be recorded on vital monitor | Post intubation (10 minute) | 
| Mean arterial pressure (mm Hg): After IV Propofol | Diastolic blood pressure (mm Hg) will be recorded on vital monitor | Immediately After IV Propofol | 
| Mean arterial pressure (mm Hg): Baseline before IV fluid infusion | Diastolic blood pressure (mm Hg) will be recorded on vital monitor | Baseline before IV fluid infusion | 
| Mean arterial pressure (mm Hg): At intubation (0 minute) | Diastolic blood pressure (mm Hg) will be recorded on vital monitor | At intubation (0 minute) | 
| Mean arterial pressure (mm Hg): Post intubation (1 minute) | Diastolic blood pressure (mm Hg) will be recorded on vital monitor | Post intubation (1 minute) | 
| Mean arterial pressure (mm Hg): Post intubation (3 minute) | Diastolic blood pressure (mm Hg) will be recorded on vital monitor | Post intubation (3 minute) | 
| Mean arterial pressure (mm Hg): Post intubation (5 minute) | Diastolic blood pressure (mm Hg) will be recorded on vital monitor | Post intubation (5 minute) | 
| Mean arterial pressure (mm Hg): Post intubation (10 minute) | Diastolic blood pressure (mm Hg) will be recorded on vital monitor | Post intubation (10 minute) |