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