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Administration of Intravenous fluids pre operatively with the use of an ultrasound to know the volume status in patients undergoing orthopaedic lower limb surgeries under spinal anaesthesia to prevent post spinal anaesthesia hypotension

INFERIOR VENA CAVA COLLAPSIBILITY INDEX (IVC-CI) GUIDED FLUID THERAPY: COMPARATIVE EFFICACY OF TWO DIFFERENT CUTOFF VALUES IN PREVENTING SPINAL ANESTHESIA-INDUCED HYPOTENSION IN PATIENTS UNDERGOING ORTHOPAEDIC LOWER LIMB SURGERIES - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/02/104490
Enrollment
264
Registered
2026-02-23
Start date
Unknown
Completion date
Unknown
Last updated
2026-03-02

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

Conditions

Health Condition 1: M179- Osteoarthritis of knee, unspecified

Interventions

Intervention1: GROUP CI 35: Measure IVCCI preoperatively 1.If IVC CI is less than 35 percent : Do not administer preload fluid 2.If IVC CI is greater than 35 percent : administer 5 ml per kg crystallo

Sponsors

AIIMS Gorakhpur
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Age between 18 and 65 years. 2.ASA Physical Status classification I or II. 3. Scheduled for elective lower limb orthopedic surgery that is anticipated to require spinal anesthesia and last less than 3 hours. 4. Able to breathe spontaneously and cooperate fully with the ultrasound measurement protocol

Exclusion criteria

Exclusion criteria: 1.Contraindications to spinal anesthesia (for example coagulopathy, infection at the puncture site) 2. Pregnancy or lactation 3. Patient s refusal to participate in study 4. Patients whose IVCCI could not be assessed (poor visibility of IVC, non-co-operative patients.

Design outcomes

Primary

MeasureTime frame
Incidence of post-spinal anaesthesia hypotension (PSAH), defined as fall in Mean Arterial Pressure (MAP) less than 65 mmHg or a decrease of Mean Arterial Pressure (MAP) greater than 20 percent from baseline occurring within 30 mins of spinal anaesthesia. Timepoint: Base line, every 2 minutes post spinal anaesthesia for 30 minutes, followed by every 5 minutes till the completion of surgery.—

Secondary

MeasureTime frame
Total Fluid Volume: The cumulative volume of Ringer s Lactate administered from the start of the pre-spinal intervention up to the end of the surgical procedure. Timepoint: 1.Before spinal anaesthesisa 2.Total fluid volume at the end of surgery;Vasopressor Requirement: The total cumulative dose of rescue vasopressors like mephentermine administered or need of nor-adrenaline during the intraoperative period. Timepoint: Intra operative period post induction by spinal anaesthesia;Severity of PSAH: Incidence of severe hypotension, defined as Mean Arterial Pressure (MAP) falling below 60 mmHg for a duration exceeding 5 minutes. Timepoint: Intra operative period post induction by spinal anaesthesia;Incidence of bradycardia - heart rate less than 50 bpm. Incidence of other adverse events like nausea, vomiting, headache, hypertension. Timepoint: Intra operative period post induction by spinal anaesthesia—

Countries

India

Contacts

Public ContactDr Shaik Moinuddin

AIIMS Gorakhpur

ganesh.nimje8@gmail.com9503332784

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Mar 14, 2026