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

Primary Purpose

Post Induction Hypotension

Status
Recruiting
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
RL 10ml/kg
RL 15ml/kg
Sponsored by
Tata Main Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post Induction Hypotension

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Abhishek ChatterjeeRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

RL 10

RL 15

Arm Description

Patients of this group will receive Ringer's lactate (RL) 10ml/kg

Patients of this group will receive 15ml/kg of Ringer's lactate solution

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
April 11, 2023
Last Updated
June 28, 2023
Sponsor
Tata Main Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05924230
Brief Title
Dose Responsive Study of Ringer's Lactate Solution in Prevention of Post-induction Hypotension
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2023 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
August 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tata Main Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Induction Hypotension

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
RL 10
Arm Type
Active Comparator
Arm Description
Patients of this group will receive Ringer's lactate (RL) 10ml/kg
Arm Title
RL 15
Arm Type
Active Comparator
Arm Description
Patients of this group will receive 15ml/kg of Ringer's lactate solution
Intervention Type
Other
Intervention Name(s)
RL 10ml/kg
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
RL 15ml/kg
Intervention Description
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
Primary Outcome Measure Information:
Title
Effective dose of Ringer's lactate solution to prevent post-induction hypotension
Description
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
Time Frame
15 months
Secondary Outcome Measure Information:
Title
Effect of age, gender, types of surgery and comorbid conditions on post-induction hypotension
Description
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
Time Frame
15 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chatterjee
Phone
+917763807075
Email
dr.abhishek@tatasteel.com
First Name & Middle Initial & Last Name or Official Title & Degree
Merina Sam
Phone
+919168334563
Email
merinasam96@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abhishek Chatterjee
Organizational Affiliation
Tata Steel
Official's Role
Principal Investigator
Facility Information:
Facility Name
Abhishek Chatterjee
City
Jamshedpur
State/Province
Jharkhand
ZIP/Postal Code
831001
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Abhishek Chatterjee
Phone
+917763807075
Email
dr.abhishek@tatasteel.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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