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Spinal Anesthesia in Elderly PatientsNCT07288996

Fractionated Spinal Anesthesia With Combined Isobaric and Hyperbaric Bupivacaine for Elderly Hip Fracture Patients

A study testing Fractionated SA with isobaric and hyperbaric bupivacaine, Fractionated SA with hyperbaric bupivacaine and Conventional SA group in people with Spinal Anesthesia in Elderly Patients, run by Tanta University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This prospective randomized controlled study will be conducted to compare the effect of fractionated SA using isobaric and hyperbaric bupivacaine with fractionated SA using hyperbaric bupivacaine and the conventional SA on hemodynamic instability in orthogeriatric patients undergoing hip fracture surgeries. Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Spinal Anesthesia in Elderly Patients
What is being tested?
Fractionated SA with isobaric and hyperbaric bupivacaine, Fractionated SA with hyperbaric bupivacaine and Conventional SA group
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
108 participants
Where
1 siteEgypt
Study dates
20 Dec 2025to 20 Jun 2026
Phase
Interventional
Are there results?
None posted in the registry

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 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • Elderly patients of both gender aged 65 years or more with American Society of Anesthesiologists (ASA) Physical Status I-III, who were scheduled for hip fracture surgeries under Spinal anesthesia

Who cannot join

  • Patients declined to participate in the trial.
  • Patients on anticoagulation therapy.
  • Patients planned for general anesthesia.
  • Patients with atrial fibrillation.
  • Allergies or hypersensitivity to local anesthetic drugs.
  • Spinal cord deformities.
  • Infection that contraindicate SA.
  • Preoperative motor and sensory deficits

Trial locations and contacts

1 site in 1 country.

Egypt1 site

  • Tanta university hospital

    Tanta

Other trials in Egypt

About this study

Official title: Fractionated Spinal Anesthesia With Combined Isobaric and Hyperbaric Bupivacaine Toward Safer Anesthesia for Elderly Hip Fracture Patients: Randomized Controlled Study

This prospective randomized controlled study will be conducted to compare the effect of fractionated SA using isobaric and hyperbaric bupivacaine with fractionated SA using hyperbaric bupivacaine and the conventional SA on hemodynamic instability in orthogeriatric patients undergoing hip fracture surgeries.

Read the detailed description

Hip fractures are one of the most common reasons for elderly patients to present to the emergency department and require urgent surgery. Despite the debate regarding the preferred type of anesthesia in the elderly population, spinal anesthesia has shown the advantage of the simplicity of the technique, the better analgesic profile, the lower incidence of thromboembolic events and lower hospital stay. Hemodynamic stability should be considered as a primary intraoperative target. In pursuit of optimizing spinal anesthesia, this study proposed that fractionated SA by sequential administration of low doses of isobaric and hyperbaric bupivacaine can minimize hemodynamic instability while leveraging the advantages of both solutions when compared with fractionated SA using hyperbaric bupivacaine or the conventional SA technique.

Being tested
Fractionated SA with isobaric and hyperbaric bupivacaine, Fractionated SA with hyperbaric bupivacaine, Conventional SA group
Keywords
Fractionated spinal anesthesia, hyperbaric bupivacaine, isobaric bupivacaine, hip fructure, elderly patients

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Fractionated SA with isobaric and hyperbaric bupivacaineProcedure or surgery

    Also called Arm 1

    patients will receive fractionated SA in two doses first dose of hyperbaric bupivacaine with fentanyl followed after 90 seconds by the second dose of isobaric bupivacaine.

  • Fractionated SA with hyperbaric bupivacaineProcedure or surgery

    Also called Arm 2

    patients will receive fractionated SA in two doses of hyperbaric bupivacaine and fentanyl, two thirds of the dose will be given firstly followed by the last third after 90 seconds.

  • Conventional SA groupProcedure or surgery

    Also called Arm 3

    patients will receive the conventional SA bolus dose of hyperbaric bupivacaine and fentanyl.

Study groups in NCT07288996
Study groupRoleWhat they receive
Fractionated SA with isobaric and hyperbaric bupivacaineExperimentalpatients will receive fractionated SA in two doses first dose of hyperbaric bupivacaine with fentanyl followed after 90 seconds by the second dose of isobaric bupivacaine.
Receives: Procedure: Fractionated SA with isobaric and hyperbaric bupivacaine
Fractionated SA with hyperbaric bupivacaine groupActive comparatorpatients will receive fractionated SA in two doses of hyperbaric bupivacaine and fentanyl, two thirds of the dose will be given firstly followed by the last third after 90 seconds.
Receives: Procedure: Fractionated SA with hyperbaric bupivacaine
Conventional SA groupActive comparatorpatients will receive the conventional SA bolus dose of hyperbaric bupivacaine and fentanyl.
Receives: Procedure: Conventional SA group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of intraoperative hypotension

    Intraoperative hypotension is defined as the drop of systolic blood pressure (SBP) by 25% of the basal reading or the drop of MAP below 65 mmHg.

    Measured: MAP will be measured intraoperatively before spinal anesthesia (SA), immediately after administering SA and subsequently at regular intervals 5, 10, 20, 30, 60, 75, 90 minutes, and then every 30 minutes till the end of surgery.

Secondary outcomes (4)

  1. Incidence of bradycardia.

    Bradycardia is defined as sustained HR less than 60 beat/ minute

    Measured: HR will be measured intraoperatively before spinal anesthesia (SA), immediately after administering SA and subsequently at regular intervals 5, 10, 20, 30, 60, 75, 90 minutes, and then every 30 minutes till the end of surgery.

  2. Vasopressor requirements.

    total dose of vasopressors required intraoperatively

    Measured: intraoperatively after spinal anesthesia till the end of surgical intervention

  3. Postoperative pain score

    Visual analogue scale (VAS) is typically a 10-cm horizontal line labeled:

    • 0 = No pain
    • 10 = Worst imaginable pain

    A patient marks a point along the line to indicate their level of pain. The score is then measured in centimeters or millimeters to quantify pain intensity.

    Measured: immediately post operatively then every 30 minutes up to 2 hour

  4. Time to first rescue analgesia

    time interval from the end of surgery until need of rescue analgesia

    Measured: post operative .. time interval from the end of surgery until need of rescue analgesia

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Dec 2025
  2. Study start20 Dec 2025
  3. Primary completion1 Jun 2026
  4. Study completion20 Jun 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
108 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07288996
Sponsor's protocol ID
36264PR131034/10/25
Status last verified
Dec 2025
First submitted
20 Nov 2025
Last updated
31 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The data will be available upon a reasonable request from the corresponding author

Publications

  • James LA, Levin MA, Lin HM, Deiner SG. Association of Preoperative Frailty With Intraoperative Hemodynamic Instability and Postoperative Mortality. Anesth Analg. 2019 Jun;128(6):1279-1285. doi: 10.1213/ANE.0000000000004085.

    PubMed 31094800

  • Meyhoff CS, Hesselbjerg L, Koscielniak-Nielsen Z, Rasmussen LS. Biphasic cardiac output changes during onset of spinal anaesthesia in elderly patients. Eur J Anaesthesiol. 2007 Sep;24(9):770-5. doi: 10.1017/S0265021507000427. Epub 2007 Apr 27.

    PubMed 17462120

  • Messina A, Frassanito L, Colombo D, Vergari A, Draisci G, Della Corte F, Antonelli M. Hemodynamic changes associated with spinal and general anesthesia for hip fracture surgery in severe ASA III elderly population: a pilot trial. Minerva Anestesiol. 2013 Sep;79(9):1021-9. Epub 2013 May 2.

    PubMed 23635998

  • Alrefaey AK, Bakrey SA. Sequential Intrathecal Injection of Hyperbaric and Isobaric Bupivacaine in Orthogeriatric Lower Limb Surgery, a Prospective Randomized Study. Asian J Anesthesiol. 2022 Jun 1;60(2). doi: 10.6859/aja.202206_60(2).0004. Epub 2022 May 4.

    PubMed 35607733

  • Niu Z, Xu X, Chu H, Yin J. Anesthetic management of hip fracture in geriatric patient with respiratory and heart failure using pericapsular nerve group block: A case report. Medicine (Baltimore). 2022 Jun 3;101(22):e29478. doi: 10.1097/MD.0000000000029478.

    PubMed 35665737

  • Carpintero P, Caeiro JR, Carpintero R, Morales A, Silva S, Mesa M. Complications of hip fractures: A review. World J Orthop. 2014 Sep 18;5(4):402-11. doi: 10.5312/wjo.v5.i4.402. eCollection 2014 Sep 18.

    PubMed 25232517

Questions about this trial

What is this clinical trial studying?

A study testing Fractionated SA with isobaric and hyperbaric bupivacaine, Fractionated SA with hyperbaric bupivacaine and Conventional SA group in people with Spinal Anesthesia in Elderly Patients, run by Tanta University at 1 site in Egypt.

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 8 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: finished, as of the sponsor's last update on 31 Jul 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 Egypt. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Incidence of intraoperative hypotension (time frame: MAP will be measured intraoperatively before spinal anesthesia (SA), immediately after administering SA and subsequently at regular intervals 5, 10, 20, 30, 60, 75, 90 minutes, and then every 30 minutes till the end of surgery.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07288996, which also lists 6 linked publications.

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 31 Jul 2026.

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