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OpenTrials
Enrolling by invitation

NCT Number: NCT07752303

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

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

Enrolling by invitation

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Dr Faisal Masood teaching Hospital sargodha

Sargodha, Pakistan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

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

Treatment and study plan

Unilateral spinal anesthesia

Procedure

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

General Anesthesia

Procedure

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)

Primary outcomes

  1. Intraoperative hemodynamic stability

    Time frame: Hemodynamic will be monitor for 90 min

  2. Intraoperative vasopressor requirement

    Time frame: Through out the surgery vasopressor requirement

Sponsors and collaborators

Lead sponsor

Sargodha Medical College

Other

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Aug 7, 2026
Registry last updated
Aug 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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