Actively Recruiting

Phase Not Applicable
Age: 60Years - 80Years
All Genders
ID07363941

Comparison of Hemodynamic and Anesthetic Outcomes Between Height-Based and Conventional Spinal Anesthetic Dosing in Elderly Patients Undergoing Lower Limb Orthopedic Surgeries

Led by Shaheed Mohtarma Benazir Bhutto Institue of Trauma · Updated on 2026-01-23

104

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating whether using a height-based dosing method for spinal anesthesia provides better heart and blood pressure stability along with improved anesthetic effects compared to a fixed dose in elderly patients undergoing lower limb orthopedic surgeries. The study aims to determine if height-based dosing reduces risks of low blood pressure and slow heart rate during surgery and whether it improves the onset and duration of sensory and motor block. This investigation focuses on patients aged 60 to 80 scheduled for elective lower limb surgeries under spinal anesthesia. Participants will be randomly assigned to one of two groups. Group A will receive a dose of 0.07 mg per cm of 0.5% Hyperbaric Bupivacaine combined with 2 mg of preservative-free Dexamethasone injected into the spinal space. Group B will receive a conventional fixed dose of 12.5 mg of 0.5% Hyperbaric Bupivacaine with the same amount of Dexamethasone. Spinal anesthesia will be administered in the sitting position at the L3-4 vertebra, followed by monitoring sensory and motor block using standard techniques. Patients will be positioned supine after injection for assessment. During the procedure, heart rate and blood pressure will be continuously monitored to detect bradycardia and hypotension. Sensory and motor block onset and duration will be recorded until their resolution. Data including demographics and clinical characteristics will be collected and securely stored for analysis. The study includes preloading with IV fluids before anesthesia and follows patients in the early postoperative period to monitor anesthetic effects. Participation lasts through surgery and immediate recovery, with all safety data documented carefully.

CONDITIONS

Brief Title

HEIGHT-BASED AND CONVENTIONAL SPINAL ANAESTHETIC DOSING IN GERIATRIC PATIENTS

Who Can Participate

Age: 60Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Individuals aged 60 to 80 years
  • Either gender (male or female)
  • Patients with ASA physical status I to III
  • Scheduled for elective lower limb orthopedic surgeries (e.g., fracture fixation, total knee replacement, open reduction and internal fixation)
  • Planned to receive spinal anesthesia as the primary anesthetic technique
  • Provided informed written consent for study participation
Not Eligible

You will not qualify if you...

  • Height less than 150 cm
  • Currently receiving antihypertensive drugs, beta blockers, or beta-agonists
  • History of neurological diseases such as stroke or Parkinsonism
  • Presence of sepsis with at least 2 positive SIRS criteria and positive blood or wound culture
  • History of coagulation disorders or recent anti-platelet drug use within 2 weeks
  • Known hypersensitivity to study drugs
  • Skin infection at the spinal needle puncture site
  • Undergoing emergency orthopedic surgeries requiring immediate intervention

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person) for consent and eligibility assessment

Treatment

Duration - Day of surgery

Participants receive spinal anesthesia with either height-based or conventional dosing during lower limb orthopedic surgery. Hemodynamic and anesthetic outcomes are monitored continuously during this period.

1 surgical procedure visit (in-person) with continuous monitoring

Post-operative Follow-up

Duration - Until the end of sensory and motor blockade

Participants are observed in the early postoperative period to monitor the duration of sensory and motor blockade and any hemodynamic changes.

Approximately 1 to 2 visits post-surgery

Trial Site Locations

Total: 1 location

1

Shaheed Mohtarma Benazir Bhutto Institue of Trauma

Karachi, Sindh, Pakistan, 74600

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

The effects on sensorial block, motor block, and haemodynamics of levobupivacaine at different temperatures applied in the subarachnoid space.

Bahittin Nazli, Huseyin Oguzalp, Eyup Horasanli...

https://pubmed.ncbi.nlm.nih.gov/24772412

Effective Dose Range of Intrathecal Isobaric Bupivacaine to Achieve T5-T10 Sensory Block Heights for Elderly and Overweight Patients: An Observational Study.

Ornwara Visavakul, Prangmalee Leurcharusmee, Tanyong Pipanmekaporn...

https://pubmed.ncbi.nlm.nih.gov/36984485