ClinicalTrials.gg
Enrolling by invitationNCT07752303Updated Aug 10, 2026

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

An observational study in Hemodynamic (MAP) Stability, sponsored by Sargodha Medical College. Enrolling by invitation at 1 site in Pakistan. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-08-10.

Sponsored by Sargodha Medical College · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
78
Ages
18 Years to 70 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Hemodynamic (MAP) Stability
03

In context

Lead sponsor

Sargodha Medical College is the lead sponsor of 13 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with age 18-70year both male female having reduced ejection fraction 35 % -40%

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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. > 35 kg/m² VIII. Allergic to local anaesthetic agents
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
78 participants (estimated)
Target follow-up
1 Day
Patient registry
Yes

Interventions

  • ProcedureUnilateral 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 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)

06

What researchers measure

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

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jul 2026 (actual). Primary completion is estimated for Dec 2026, 5 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 3, 2026
First posted
Aug 7, 2026
StartActual
Jul 5, 2026
Primary completionEst.
Dec 2026
CompletionEst.
Dec 2026
Last update
Aug 10, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 10, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07752303
Lead sponsor
Sargodha Medical College
Responsible party
Sponsor
First posted
Aug 7, 2026
Start date
Jul 5, 2026
Primary completion
Dec 2026 (estimated)
Completion
Dec 2026 (estimated)
Last update
Aug 10, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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