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

NCT04736498 | Completed

• 1 other identifier: 308/075/076
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypotension; Fluid Overload

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Comparison of incidence of hypotension between two groups

  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.

  30 minutes after spinal anaesthesia

Secondary Outcomes (2)

• Analyse amount of fluids administered between two groups

  30 minutes after spinal anaesthesia

• Compare vasopressors used between two groups

  30 minutes after spinal anaesthesia

Study Arms (2)

Control arm

NO INTERVENTION

Control group will follow the standard procedure in our centre and will not undergo USG assessment before spinal anaesthesia. The spinal anaesthesia procedure will be standardized. Under strict aseptic precautions spinal anesthesia will be performed at L3-L4 inter-space using a 25 Gauge Quincke spinal needle (B. Braun Medical SA, Melsungen, Germany) in sitting position. 3 ml of hyperbaric bupivacaine 0.5% (15 mg) will be injected with the needle orifice oriented cranially. After injection, patients will be immediately positioned supine. Meanwhile, the non-invasive blood pressure will be measured and recorded every 3 minute for 30 min and then every 5 min throughout surgery and anesthesia.

USG arm

EXPERIMENTAL

In the IVC USG group, USG assessment and volume optimisation using collapsibility index will be done prior to spinal anaesthesia. all patients will be lying supine, for at least 5 min before IVC examination. Ultrasound measurements will be performed using a Sonosite M-Turbo (Sonosite Inc., USA) machine and phased array 5-1 Megahertz transducer (Sonosite Inc.) set to abdominal mode by an M-mode modality through the subcostal view. All IVC measurements will be performed by principal investigator before spinal anaesthesia. Principal investigator should have performed more than 25 scans before the commencement of the study.

Other: Inferior venacava Ultrasonography (IVC USG) guided fluid management

Interventions

Inferior venacava Ultrasonography (IVC USG) guided fluid management OTHER

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.

USG arm

Eligibility Criteria

• Age: 16 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tribhuvan University, Nepal: lead
• Tribhuvan University: collaborator

Study Sites (1)

Semanta Dahal

Maharajgunj, Bagmati, 44600, Nepal

Location

Related Publications (27)

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MeSH Terms

Conditions

Hypotension; Edema

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Semanta Dahal, MBBS, MD

  Institute of Medicine (IOM), Tribhuvan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MBBS, MD

Study Record Dates

• First Submitted: January 29, 2021
• First Posted: February 3, 2021
• Study Start: December 12, 2018
• Primary Completion: September 10, 2019
• Study Completion: January 20, 2020
• Last Updated: February 5, 2021

Record last verified: 2021-02

Locations

NE (1)