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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Post Induction Hypotension
• Intervention / Treatment: Other: RL 10ml/kg; Other: RL 15ml/kg

Detailed Description

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 :

1. Baseline parameters - Prior to administration of intravenous Ringer's lactate solution
2. T0 (after administration of intravenous Ringer's lactate solution but prior to induction of anaesthesia),
3. 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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chatterjee; Phone Number: +917763807075; Email: dr.abhishek@tatasteel.com
• Study Contact Backup: Name: Merina Sam; Phone Number: +919168334563; Email: merinasam96@gmail.com

Study Locations

• India
  • Jharkhand
    • Jamshedpur, Jharkhand, India, 831001
      • Recruiting
      • Abhishek Chatterjee
      • Contact: Abhishek Chatterjee; Phone Number: +917763807075; Email: dr.abhishek@tatasteel.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: RL 10; Patients of this group will receive Ringer's lactate (RL) 10ml/kg	Other: RL 10ml/kg; 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
Active Comparator: RL 15; Patients of this group will receive 15ml/kg of Ringer's lactate solution	Other: RL 15ml/kg; 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Tata Main Hospital
• Investigators: Principal Investigator: Abhishek Chatterjee, Tata Steel

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2023
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): August 31, 2024

Study Registration Dates

• First Submitted: April 11, 2023
• First Submitted That Met QC Criteria: June 28, 2023
• First Posted (Actual): June 29, 2023

Study Record Updates

• Last Update Posted (Actual): June 29, 2023
• Last Update Submitted That Met QC Criteria: June 28, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypotension
• Other Study ID Numbers: TMH/IEC/JUNE/011/2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No