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

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

Status
Enrolling by invitation
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07752303
Enrollment
78
Registered
2026-08-07
Start date
2026-07-05
Completion date
2026-12-01
Last updated
2026-08-10

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

Conditions

Hemodynamic (MAP) Stability

Brief summary

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

Interventions

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 injected intrathecal. The lateral position will be maintained for approximately 10 minutes to achieve a unilateral block. Analgesia will also be maintained by using Ketorolac and Acetaminophen if there would be any complain of Pain. Continuous monitoring of HR, MAP, and SpO₂ will be undertaken to ensure stability

PROCEDUREGeneral 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 Acetaminophen. At the end of surgery , Remaining muscular relaxation will be neutralized by administering neostigmine (0.05mg/kg)

Sponsors

Sargodha Medical College
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

1\. Patient Age/Gender : 18-70 Years Male / Female. 2 Elective lower-limb surgery 3. Patients with reduced Ejection Fraction: rEF ( 35-40%) 4 ASA Class II-III

Exclusion criteria

1. Emergency surgery. 2. Coagulopathy. 3. Spinal deformity or infection. 4. Drug allergy. 5. Severe pulmonary disease VI. Psychiatric and Neurological Illness. VII. BMI \> 35 kg/m² VIII. Allergic to local anaesthetic agents

Design outcomes

Primary

MeasureTime frame
Intraoperative hemodynamic stabilityHemodynamic will be monitor for 90 min
Intraoperative vasopressor requirementThrough out the surgery vasopressor requirement

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 11, 2026