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Enrolling by invitation NCT07752303

Unilateral Spinal vs General Anaesthesia in Low EF Patients: A Hemodynamic Comparison*

Observational Hemodynamic (MAP) Stability

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Unilateral spinal anesthesia, General anesthesia.
Who it may be relevant to
Registry conditions: Hemodynamic (MAP) Stability. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Pakistan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

COMPARISON BETWEEN UNILATERAL SPINAL ANAESTHESIA AND GENERAL ANAESTHESIA IN PATIENTS WITH REDUCED EJECTION FRACTION (35-40%) UNDERGOING LOWER LIMB SURGERY IN TERMS OF INTRAOPERATIVE HEMODYNAMIC STABILITY

Overview

A difference exists in intraoperative hemodynamic stability and vasopressor requirement between the two techniques

Interventions

  • Procedure Unilateral spinal anesthesia
    Patients (Selected for Unilateral Spinal Anaesthesia, UniSA) will be positioned laterally with the operative side dependent. Following aseptic preparation, Patient will be given a small volume of preload of Ringer Lactate (3-5ml /kg) i.e 250-300ml to avoid Spinal induced hypotension and to minimize fluid overload due to reduced ejection fraction. After giving preload, A 25-gauge Quincke needle will be introduced at the L3-L4 interspace, and 1.0 ml (7.5 mg) of 0.75% hyperbaric bupivacaine will be
  • Procedure General anesthesia
    Anaesthesia induction will be achieved with IV propofol (1-2 mg/kg) and nalbuphine (0.1 mg/kg) for analgesia. Neuromuscular relaxation will be achieved with atracurium (0.5 mg/kg) and additional doses will be given as needed. Anaesthesia will be maintained with isoflurane in a mix of oxygen and air. If the heart rate or mean arterial pressure rises by more than 20% from baseline, an extra dose of nalbuphine (2 to 3 mg IV) will be given. Analgesia will also be maintained by using Ketorolac and Ac

Primary outcome measures

  • Intraoperative hemodynamic stability [Time frame: Hemodynamic will be monitor for 90 min]
  • Intraoperative vasopressor requirement [Time frame: Through out the surgery vasopressor requirement]

Eligibility criteria

Inclusion criteria

I. Patient Age/Gender : 18-70 Years Male / Female. II. Elective lower-limb surgery III. Patients with reduced Ejection Fraction: rEF ( 35-40%) IV. ASA Class II-III

Exclusion criteria

I. Emergency surgery. II. Coagulopathy. III. Spinal deformity or infection. IV. Drug allergy. V. Severe pulmonary disease VI. Psychiatric and Neurological Illness. VII. BMI > 35 kg/m² VIII. Allergic to local anaesthetic agents

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Other

Study locations

Pakistan · 1 center
  • Dr Faisal Masood teaching Hospital sargodha — Sargodha

Identifiers

NCT: NCT07752303 · SMC-ANS-2026-010

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗