HEIGHT-BASED AND CONVENTIONAL SPINAL ANAESTHETIC DOSING IN GERIATRIC PATIENTS

January 15, 2026 updated by: Jehanzaib Muhammad Azam, Shaheed Mohtarma Benazir Bhutto Institue of Trauma

COMPARISON OF HEMODYNAMIC AND ANAESTHETIC OUTCOMES BETWEEN HEIGHT-BASED AND CONVENTIONAL SPINAL ANAESTHETIC DOSING IN GERIATRIC PATIENTS UNDERGOING LOWER LIMB ORTHOPAEDIC SURGERIES

The goal of this clinical trial is to find out whether height-based dosing of spinal anaesthesia provides better hemodynamic stability and anesthetic outcome than conventional fixed dosing in elderly patients undergoing lower limb orthopaedic surgery.The main questions this study aims to answer are:

  1. Does height-based spinal anaesthetic dosing reduce the risk of hypotension and bradycardia during surgery as compared to conventional fixed dosing?
  2. Does it improve anaesthetic outcomes, such as the onset and duration of sensory and motor block?

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Data collection would begin after the approval of ethical review committee of the institution. This investigation will encompass patients who are scheduled to undergo lower limb orthopaedic surgical procedures within the Department of Anaesthesia, SMBBIT, Karachi. Following a comprehensive description of the study and their acceptance to participate (written consent), the subject will be recruited as detailed in the inclusion criteria.

Data will be collected using a defined data collection proforma to record baseline demographics and clinical characteristics including age, height, gender, and residential status. Height will be measured in the supine position as the patients will be undergoing lower limb surgeries. The patient will be placed flat on a firm examination table or operating-room bed without a pillow, with legs extended and neutral. To accurately measure height in centimetres, a measuring tape or stadiometer will be placed along the length of the patient's body from the heel to the vertex of the head, using trained staff to ensure precise placement, and the reading will be recorded to the nearest decimal point.

The subjects will be allocated to one of two groups through a computer-generated random number sequence with concealed allocation to mitigate selection bias and safeguard the integrity of the randomization process. Allocation concealment will be accomplished by the Sequentially Numbered, Opaque, Sealed Envelope (SNOSE) method, conducted by a blinded independent researcher not involved in subject recruitment, surgical procedure, or clinical assessment. In the operating room, baseline pulse rate and mean arterial pressure will be measured before spinal anaesthesia is induced. Intravenous access will be established, and patients will be preloaded with Ringer Lactate (10 ml/kg) prior to induction of spinal anaesthesia.

Spinal anaesthesia will be provided in the sitting position, aseptically at the level of L3-4 vertebra. Group A will receive 0.07 mg/cm of 0.5% Hyperbaric Bupivacaine in conjunction with 2 mg (0.5 ml) of preservative-free Dexamethasone administered intrathecally, whereas patients in Group B will be administered 12.5 mg (2.5 ml) of 0.5% Hyperbaric Bupivacaine alongside 2 mg (0.5 ml) of preservative-free Dexamethasone. Subsequent to the administration of spinal anaesthesia, patients will be positioned in the supine orientation; sensory blockade will be evaluated utilizing the pinprick method with a blunt-tipped 23-gauge needle at the T10 dermatome level, while motor blockade will be assessed employing the Bromage scale. The specific time at which the most effective sensory and motor blockade is achieved will be documented in accordance with the established operational definition.

The hemodynamic (heart rate and mean arterial pressure) will be continuously monitored. The procedure and the principal investigator (in consultation with a faculty consultant with >5 years' experience) will mark the findings of "bradycardia" and "hypotension" based on the operational definition on the proforma. The early postoperative period will be followed in all patients in order to know sensory and motor blockade duration by operational definition, and each result will be written. The principal investigator will record collected data on a predesigned proforma. Confidentiality will be ensured along with data security measures allowing only authorized personnel access to all information. The study is produced to be directly relevant with its aims, and rigorous exclusion criteria will be used in minimizing potential biases or confounders.

Data will be entered into a secure database and analyzed using SPSS version 26. Continuous variables (including age, height, weight, BMI, heart rate, mean arterial pressure, onset of sensory block, and duration of sensory block) will be summarized as mean ± standard deviation or median with interquartile range, as appropriate. Comparisons between the two study groups will be performed using the independent sample t-test for continuous variables. Chi-square test or Fisher's exact test will be used for categorical variables, depending on expected cell counts. A p-value ≤ 0.05 will be considered statistically significant.

Study Type

Interventional

Enrollment (Estimated)

104

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Sindh
      • Karachi, Sindh, Pakistan, 74600
        • Recruiting
        • Shaheed Mohtarma Benazir Bhutto Institue of Trauma
        • Contact:
          • Dr Sidra Javed Consultant Anesthetist, MBBS, FCPS, PAIN FELLOW
          • Phone Number: +923332474831
          • Email: sidra_dow@yahoo.com
        • Contact:
          • Dr Mirza Shahzad Baig Consultant Anesthetist, MBBS, MCPS, FCPS
          • Phone Number: +923346441539
          • Email: drshahzadbaig@hotmail.com
        • Principal Investigator:
          • Jehanzaib Muhammad Azam, MBBS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Individuals aged 60 to 80 years. Either gender (male or female). Patients who are ASA physical status I-III. Individuals scheduled to undergo elective lower limb orthopaedic surgeries (e.g., fracture fixation, total knee replacement, open reduction and internal fixation).

Patients planned to receive spinal anaesthesia as the primary anaesthetic technique.

Those who provide informed written consent for participation in the study.

Exclusion Criteria:

Individuals exhibiting a stature inferior to 150 cm. Patients receiving anti-hypertensive drugs or those on beta blockers or beta-agonists.

Patients with a history of neurological disease like CVA or Parkinsonism. Patients presenting with sepsis (≥ 2 positive SIRS criteria with positive aseptically obtained blood or wound culture).

Patients with a history of coagulation disorders like haemophilia or vWD or those with a history of anti-platelet drug intake in the last 2 weeks.

Individuals possessing a documented history of hypersensitivity reactions to pharmacological agents utilized in the research.

Patients who will be diagnosed with a skin infection at the spinal needle puncture site.

Patients undergoing emergency orthopaedic procedures requiring immediate intervention

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A
Participants will receive 0.07 mg/cm of 0.5% Hyperbaric Bupivacaine in conjunction with 2 mg (0.5 ml) of preservative-free Dexamethasone administered intrathecally
Drug: Group A : Spinal Anaesthetic Dose
Participants will receive 0.07 mg/cm of 0.5% Hyperbaric Bupivacaine in conjunction with 2 mg (0.5 ml) of preservative-free Dexamethasone administered intrathecally
Active Comparator: Group B
Participants will recieve 12.5 mg (2.5 ml) of 0.5% Hyperbaric Bupivacaine alongside 2 mg (0.5 ml) of preservative-free Dexamethasone administered intrathecally
Drug: Group B : Conventional Dose
Participants will receive 12.5 mg (2.5 ml) of 0.5% Hyperbaric Bupivacaine alongside 2 mg (0.5 ml) of preservative-free Dexamethasone intrathecally

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HYPOTENSION
Time Frame: Subsequent to the administration of spinal anaesthesia till the end of sensory and motor blockade
Defined as a decrease of ≥20% in mean arterial pressure (MAP) from baseline or an absolute MAP <65 mmHg at any point during surgery, recorded using non-invasive blood pressure monitoring at five-minute intervals
Subsequent to the administration of spinal anaesthesia till the end of sensory and motor blockade
BRADYCARDIA
Time Frame: Subsequent to the administration of spinal anaesthesia till the end of sensory and motor blockade
It will be defined in terms of a heart rate of ≤ 60 beats/minute during surgery
Subsequent to the administration of spinal anaesthesia till the end of sensory and motor blockade
ONSET OF SENSORY BLOCK
Time Frame: Subsequent to the administration of spinal anaesthesia till the attainment of sensory blockade
It will be defined as the time interval (in minutes) from the completion of intrathecal injection of bupivacaine to the loss of pinprick sensation at the T10 dermatome. The assessment will be carried out using a sterile blunt 23-gauge needle at one-minute intervals until loss of sensation is confirmed.
Subsequent to the administration of spinal anaesthesia till the attainment of sensory blockade
DURATION OF SENSORY BLOCK
Time Frame: Subsequent to the administration of spinal anaesthesia till the end of sensory blockade
It will be defined as the time interval (in minutes) from the onset of sensory block at the T10 dermatome (confirmed by loss of pinprick sensation) to the reappearance of sensation at the same dermatome level. The response will be assessed every 5 minutes using a sterile blunt 23-gauge needle.
Subsequent to the administration of spinal anaesthesia till the end of sensory blockade
ONSET OF MOTOR BLOCK
Time Frame: Subsequent to the administration of spinal anaesthesia till the attainment of motor blockade
It will be defined as the time duration (in minutes) between the completion of intrathecal administration of bupivacaine until the patient develops Bromage III
Subsequent to the administration of spinal anaesthesia till the attainment of motor blockade
DURATION OF MOTOR BLOCK
Time Frame: Subsequent to the administration of spinal anaesthesia till the end of motor blockade
The duration of motor block is defined as the time duration (in minutes) from the onset of motor block (inability to move feet) until the patient regains the ability to voluntarily move both feet.
Subsequent to the administration of spinal anaesthesia till the end of motor blockade

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shaheed Mohtarma Benazir Bhutto Institue of Trauma

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 3, 2026

Primary Completion (Estimated)

May 3, 2026

Study Completion (Estimated)

May 4, 2026

Study Registration Dates

First Submitted

January 15, 2026

First Submitted That Met QC Criteria

January 15, 2026

First Posted (Actual)

January 23, 2026

Study Record Updates

Last Update Posted (Actual)

January 23, 2026

Last Update Submitted That Met QC Criteria

January 15, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • IRB-000210/SMBBIT/Approval/20

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Patient Confidentiality: Sharing IPD could compromise patient confidentiality and anonymity.

Informed consent: Participants are not providing informed consent for their data to be shared and it could raise ethical concerns.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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