Dose Responsive Study of Ringer's Lactate Solution in Prevention of Post-induction Hypotension
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2023
CompletedFirst Submitted
Initial submission to the registry
April 11, 2023
CompletedFirst Posted
Study publicly available on registry
June 29, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2024
CompletedJune 29, 2023
June 1, 2023
1.2 years
April 11, 2023
June 28, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Effect of age, gender, types of surgery and comorbid conditions on post-induction hypotension
15 months
Study Arms (2)
RL 10
ACTIVE COMPARATORPatients of this group will receive Ringer's lactate (RL) 10ml/kg
RL 15
ACTIVE COMPARATORPatients of this group will receive 15ml/kg of Ringer's lactate solution
Interventions
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
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
Eligibility Criteria
You may qualify if:
- Age ≥ 18 years American Society of Anesthesiologists (ASA) Physical status classification system group I and II Elective surgery under General anesthesia
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Abhishek Chatterjee
Jamshedpur, Jharkhand, 831001, India
Study Officials
- PRINCIPAL INVESTIGATOR
Abhishek Chatterjee
Tata Steel
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Consultant
Study Record Dates
First Submitted
April 11, 2023
First Posted
June 29, 2023
Study Start
April 1, 2023
Primary Completion
June 30, 2024
Study Completion
August 31, 2024
Last Updated
June 29, 2023
Record last verified: 2023-06
Data Sharing
- IPD Sharing
- Will not share