Hemodynamic (MAP) StabilityNCT07752303
Unilateral Spinal vs General Anaesthesia in Low EF Patients: A Hemodynamic Comparison
An observational study of Hemodynamic (MAP) Stability, run by Sargodha Medical College at 1 site in Pakistan.
Trial summary
A difference exists in intraoperative hemodynamic stability and vasopressor requirement between the two techniques Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hemodynamic (MAP) Stability
- What is being tested?
- Unilateral spinal anesthesia and General anesthesia
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 78 participants
- Where
- 1 sitePakistan
- Study dates
- 5 Jul 2026to Dec 2026
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with age 18-70year both male female having reduced ejection fraction 35 % -40%
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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
A difference exists in intraoperative hemodynamic stability and vasopressor requirement between the two techniques
- Conditions
- Hemodynamic (MAP) Stability
- Being tested
- Unilateral spinal anesthesia, General anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unilateral spinal anesthesiaProcedure or surgery
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 anesthesiaProcedure or surgery
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)
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative hemodynamic stability
Measured: Hemodynamic will be monitor for 90 min
Intraoperative vasopressor requirement
Measured: Through out the surgery vasopressor requirement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2026
- Study start5 Jul 2026
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemodynamic (MAP) StabilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 78 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Sargodha Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07752303
- Sponsor's protocol ID
- SMC-ANS-2026-010
- Status last verified
- Aug 2026
- First submitted
- 3 Aug 2026
- Last updated
- 10 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07752303
- Acronym / sponsor ID
- SMC-ANS-2026-010
- Conditions
- Hemodynamic (MAP) Stability
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Sargodha Medical CollegeUniversity, hospital or other
- Study start
- 5 Jul 2026 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 7 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A difference exists in intraoperative hemodynamic stability and vasopressor requirement between the two techniques
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with age 18-70year both male female having reduced ejection fraction 35 % -40%
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Unilateral spinal anesthesiaPatients (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 | Procedure or surgery | – |
| General anesthesiaAnaesthesia 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) | Procedure or surgery | – |
Primary outcome
Intraoperative hemodynamic stability
Time frame: Hemodynamic will be monitor for 90 min
Intraoperative vasopressor requirement
Time frame: Through out the surgery vasopressor requirement
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemodynamic (MAP) Stability, run by Sargodha Medical College at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraoperative hemodynamic stability (time frame: Hemodynamic will be monitor for 90 min). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2026.