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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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05924230
Enrollment
100
Registered
2023-06-29
Start date
2023-04-01
Completion date
2024-08-31
Last updated
2023-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post Induction Hypotension

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 : 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.

Interventions

OTHERRL 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

OTHERRL 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

Sponsors

Tata Main Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Effective dose of Ringer's lactate solution to prevent post-induction hypotension15 monthsThis 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

MeasureTime frameDescription
Effect of age, gender, types of surgery and comorbid conditions on post-induction hypotension15 monthsThis 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

Countries

India

Contacts

Primary ContactChatterjee
dr.abhishek@tatasteel.com+917763807075
Backup ContactMerina Sam
merinasam96@gmail.com+919168334563

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026