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Inferior Venacava Ultrasound to Guide Fluid Management for Prevention of Hypotension After Spinal Anesthesia.

Inferior Venacava Ultrasound to Guide Fluid Management for Prevention of Hypotension After Spinal Anesthesia.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04736498
Enrollment
92
Registered
2021-02-03
Start date
2018-12-12
Completion date
2020-01-20
Last updated
2021-02-05

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

Conditions

Fluid Overload, Hypotension

Keywords

Collapsibility index, Inferior venacava ultrasound, Spinal anesthesia, Transthoracic echocardiography

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 Place: Operating theatres of Tribhuvan University Teaching Hospital (TUTH), Maharajgunj Medical Campus (MMC), Institute of Medicine (IOM). Interventions: A total of 92 patients undergoing lower limb orthopedic surgery will be enrolled in the study. They will be randomized into USG group and Control group. In the USG group, IVC ultrasound will be done and collapsibility index (CI) will be calculated. Depending upon the value of calculated CI, fluid management will be done by infusing Ringer's Lactate (RL). Thereafter spinal anesthesia will be performed. In the control group, spinal anesthesia will be performed without IVC USG assessment. In both the groups, incidence of hypotension and amount of fluid and vasopressors administered will be recorded.

Interventions

OTHERInferior venacava Ultrasonography (IVC USG) guided fluid management

The IVC will be visualized using a paramedian long-axis view via a subcostal approach. A two-dimensional image of the IVC as it enters the right atrium will be first obtained. Variations in IVC diameter with respiration will be assessed using M-mode imaging performed 2 to 3 cm distal to the junction of right atrium and IVC. Maximum and minimum diameter will be measured from inner wall to inner wall and collapsibility index(CI) will be calculated using formula: CI = \[(dIVCmax - dIVCmin)/dIVCmax\] x 100% CI of ˃36% will be accepted as predicted fluid responder and ≤36% will be regarded as predicted fluid non responders. Predicted fluid responders will receive a bolus of 500 ml of Ringer's lactate over a time period of 15 min, after which the IVC diameter variation will be reassessed. Additional 250ml of Ringer's lactate bolus will be applied until a non fluid responder pattern is observed during IVC USG. Thereafter,spinal anaesthesia will be performed.

Sponsors

Tribhuvan University
CollaboratorUNKNOWN
Tribhuvan University, Nepal
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
16 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

1. Age ≥16-65 years 2. American Society of Anaesthesiology physical status (ASA PS) I and II 3. Requiring elective spinal anaesthesia for lower limb orthopaedic surgery

Exclusion criteria

1. 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. 2. Contraindication for Spinal Anaesthesia * Platelet counts ˂100,000 per microlitre of blood * International normalized ratio (INR) ≥1.5 * Bleeding disorders * Infection at injection site

Design outcomes

Primary

MeasureTime frameDescription
Comparison of incidence of hypotension between two groups30 minutes after spinal anaesthesiaTo 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

MeasureTime frameDescription
Analyse amount of fluids administered between two groups30 minutes after spinal anaesthesiaTo compare fluid adjustment requirement between USG group and control group
Compare vasopressors used between two groups30 minutes after spinal anaesthesiaTo compare the rate of vasopressors used between USG group and control group

Countries

Nepal

Outcome results

None listed

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