Inferior Venacava Ultrasound to Guide Fluid Management for Prevention of Hypotension After Spinal Anesthesia.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 92
- Locations
- 2
- Primary Endpoint
- Comparison of incidence of hypotension between two groups
Study Overview
Brief Summary
Hypotension is common during spinal anesthesia and contributes to underperfusion and ischemia. Severe episodes of intraoperative hypotension is an independent risk factor for myocardial infarction, stroke, heart failure, acute kidney injury, prolonged hospital stay and increased one year mortality rates. Empiric fluid preloading can be done to decrease the incidence of hypotension but carries risk of fluid overload especially in elderly and cardiac patients. Inferior venacava ultrasonography (IVC USG) has been used in spontaneously breathing critically ill patients for volume responsiveness but there is limited data regarding its use for volume optimization in perioperative setting. The aim of this study is to evaluate the use of inferior venacava ultrasound to guide fluid management for prevention of hypotension after spinal anesthesia.
Detailed Description
Introduction:
Hypotension is common during spinal anesthesia and contributes to underperfusion and ischemia. It occurs due to reduction in both cardiac output and systemic vascular resistance. Even short duration of intraoperative MAP less than 55 mmHg has been found to be associated with Acute kidney injury (AKI) and myocardial injury. Severe episodes of intraoperative hypotension is an independent risk factor for myocardial infarction, stroke, heart failure, acute kidney injury, prolonged hospital stay and increased 1 year mortality rates. Predictive variables for spinal anesthesia induced hypotension includes peak sensory level, chronic alcohol consumption, emergency surgery, age more than 40 years, hypertension, combined spinal/general anaesthesia(GA), spinal puncture at or above lumbar 2 lumber 3 (L2L3) interspace. Preoperative volume status is an important factor determining patient's hemodynamic status. Traditional static parameters such as central venous pressure have been criticized for invasiveness and lack of accuracy. Newer noninvasive dynamic parameters like inferior venacava diameter and Collapsibility index(CI), acoustic echocardiography, stroke volume variation and pulse pressure variation etc are being used widely for assessing volume status.
Study Objective: To evaluate the use of inferior vena cava ultrasound to guide fluid management for prevention of hypotension after spinal anesthesia.
Design: A randomized prospective interventional study
Sample size: 92
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 16 Years to 65 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age ≥16-65 years
- •American Society of Anaesthesiology physical status (ASA PS) I and II
- •Requiring elective spinal anaesthesia for lower limb orthopaedic surgery
Exclusion Criteria
- •Patients with pre-procedural hypotension, defined as two consecutive measurements of systolic arterial pressure (SAP) less than 90 mmHg or mean arterial pressure (MAP) less of 60 mmHg.
- •Contraindication for Spinal Anaesthesia
- •Platelet counts ˂100,000 per microlitre of blood
- •International normalized ratio (INR) ≥1.5
- •Bleeding disorders
- •Infection at injection site
Outcomes
Primary Outcomes
Comparison of incidence of hypotension between two groups
Time Frame: 30 minutes after spinal anaesthesia
To compare the incidence of hypotension after spinal anesthesia between two groups, USG group who have undergone volemic optimization after USG assessment and control group.
Secondary Outcomes
- Analyse amount of fluids administered between two groups(30 minutes after spinal anaesthesia)
- Compare vasopressors used between two groups(30 minutes after spinal anaesthesia)
Investigators
Semanta Dahal
MBBS, MD
Tribhuvan University, Nepal