HEIGHT-BASED AND CONVENTIONAL SPINAL ANAESTHETIC DOSING IN GERIATRIC PATIENTS

NCT07363941 | Recruiting DMC

• 1 other identifier: IRB-000210/SMBBIT/Approval/20
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Spinal Anesthesia in Elderly Patients; Geriatric Population; Spinal Anesthesia Induced Hypotension

Outcome Measures

Primary Outcomes (6)

• HYPOTENSION

  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

  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

  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

  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

  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

  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

Study Arms (2)

Group A

EXPERIMENTAL

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

Group B

ACTIVE COMPARATOR

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

Interventions

Group A : Spinal Anaesthetic Dose DRUG

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

Group A

Group B : Conventional Dose DRUG

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

Group B

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Shaheed Mohtarma Benazir Bhutto Institue of Trauma: lead

Study Sites (1)

Shaheed Mohtarma Benazir Bhutto Institue of Trauma

Karachi, Sindh, 74600, Pakistan

RECRUITING

Related Publications (8)

• Hasan SH. Randomized controlled trial on the effects of fixed-dose versus height-adjusted dose of hyperbaric bupivacaine used in spinal anaesthesia for cesarean section. J Nat Sc Biol Med. 2024;15(2):192-201.

  BACKGROUND

• Alkonaiesy RM, Amin SM, Abdallah NM, Muhammad SI, Hassan H. Effect of height-based spinal anaesthetic dose versus conventional dose on hemodynamics in lower limb surgeries in geriatric patients: a randomized controlled trial. Anaesth Pain Intensive Care. 2023;27(4):565-72.

  BACKGROUND

• Nazli B, Oguzalp H, Horasanli E, Gamli M, Dikmen B, Gogus N. The effects on sensorial block, motor block, and haemodynamics of levobupivacaine at different temperatures applied in the subarachnoid space. Biomed Res Int. 2014;2014:132687. doi: 10.1155/2014/132687. Epub 2014 Mar 18.

  PMID: 24772412 BACKGROUND

• Messina A, La Via L, Milani A, Savi M, Calabro L, Sanfilippo F, Negri K, Castellani G, Cammarota G, Robba C, Morenghi E, Astuto M, Cecconi M. Spinal anesthesia and hypotensive events in hip fracture surgical repair in elderly patients: a meta-analysis. J Anesth Analg Crit Care. 2022 May 8;2(1):19. doi: 10.1186/s44158-022-00047-6.

  PMID: 37386657 BACKGROUND

• Visavakul O, Leurcharusmee P, Pipanmekaporn T, Khorana J, Patumanond J, Phinyo P. Effective Dose Range of Intrathecal Isobaric Bupivacaine to Achieve T5-T10 Sensory Block Heights for Elderly and Overweight Patients: An Observational Study. Medicina (Kaunas). 2023 Mar 1;59(3):484. doi: 10.3390/medicina59030484.

  PMID: 36984485 BACKGROUND

• Al Harbi MK, Alshaghroud SM, Aljahdali MM, Ghorab FA, Baba F, Al Dosary R, Bahadeq M. Regional anesthesia for geriatric population. Saudi J Anaesth. 2023 Oct-Dec;17(4):523-532. doi: 10.4103/sja.sja_424_23. Epub 2023 Aug 18.

  PMID: 37779559 BACKGROUND

• Lim BG, Lee IO. Anesthetic management of geriatric patients. Korean J Anesthesiol. 2020 Feb;73(1):8-29. doi: 10.4097/kja.19391. Epub 2019 Oct 22.

  PMID: 31636241 BACKGROUND

• Neuman MD, Feng R, Carson JL, Gaskins LJ, Dillane D, Sessler DI, Sieber F, Magaziner J, Marcantonio ER, Mehta S, Menio D, Ayad S, Stone T, Papp S, Schwenk ES, Elkassabany N, Marshall M, Jaffe JD, Luke C, Sharma B, Azim S, Hymes RA, Chin KJ, Sheppard R, Perlman B, Sappenfield J, Hauck E, Hoeft MA, Giska M, Ranganath Y, Tedore T, Choi S, Li J, Kwofie MK, Nader A, Sanders RD, Allen BFS, Vlassakov K, Kates S, Fleisher LA, Dattilo J, Tierney A, Stephens-Shields AJ, Ellenberg SS; REGAIN Investigators. Spinal Anesthesia or General Anesthesia for Hip Surgery in Older Adults. N Engl J Med. 2021 Nov 25;385(22):2025-2035. doi: 10.1056/NEJMoa2113514. Epub 2021 Oct 9.

  PMID: 34623788 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: This study is single blind, assessor is kept blind because participants are difficult to mask due to well distinguished treatment plan.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Jehanzaib Muhammad Azam

Model Details: 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

Study Record Dates

• First Submitted: January 15, 2026
• First Posted: January 23, 2026
• Study Start: January 3, 2026
• Primary Completion: May 3, 2026
• Study Completion: May 4, 2026
• Last Updated: January 23, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)