drugset / Trial / NCT07363941
HEIGHT-BASED AND CONVENTIONAL SPINAL ANAESTHETIC DOSING IN GERIATRIC PATIENTS
RandomizedParallel-groupSingle-blindTreatment
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. 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?
Timeline
- Start
- 2026-01-03
- Primary completion
- 2026-05-03
- Completion
- 2026-05-04
Publications
- Background 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bupivacaine | Other / unclassified | 0.07 unknown | Intrathecal |
| Subject | Bupivacaine | Other / unclassified | 12.5 mg | Intrathecal |
| Background | Dexamethasone | Small molecule | 2 mg | Intrathecal |
Indications
No indication recorded.