Effect of Lateral Decubitus Position After Spinal Anesthesia on Hemodynamic Stability in High-Risk Geriatric Patients

Официальное название

The Effects of Lateral Decubitus Positioning After Spinal Anesthesia on Hemodynamic Stability in High-Risk Geriatric Patients Undergoing Lower Extremity Orthopedic Surgery: A Prospective Randomized Controlled Trial

Обзор

Spinal anesthesia is a common and preferred anesthetic technique for lower extremity orthopedic surgery in elderly patients. However, it can cause a significant drop in blood pressure (hypotension), especially in high-risk older patients with multiple medical conditions. This complication can lead to serious consequences such as heart attack, stroke, or death in vulnerable patients. This study investigates whether keeping patients in a lateral (side-lying) position for 15 minutes after spinal anesthesia - instead of immediately turning them onto their back (supine position) - can reduce the risk of hypotension. When a patient lies on their side after receiving spinal anesthesia with a heavy (hyperbaric) local anesthetic, the medication tends to stay concentrated on the lower (operative) side, resulting in a more limited nerve block. This may help preserve blood pressure stability. We will enroll 70 patients aged 65 years or older with high anesthetic risk (ASA physical status III or IV) scheduled for unilateral lower extremity orthopedic surgery under spinal anesthesia. Patients will be randomly assigned to two groups: one group will be kept in the lateral decubitus position (operative side down) for 15 minutes before being turned supine, and the other group will be turned supine immediately after spinal anesthesia. Blood pressure, heart rate, and oxygen saturation will be monitored continuously. The primary outcome is the incidence of hypotension during the first 15 minutes after spinal anesthesia.

Вмешательства

• Другое Lateral Decubitus Positioning
  After spinal anesthesia with 12 mg of 0.5% hyperbaric bupivacaine administered in the sitting position, patients are immediately placed in the lateral decubitus position with the operative side down. This position is maintained for 15 minutes to allow gravity-dependent concentration of the hyperbaric local anesthetic on the operative side, achieving predominantly unilateral sympathetic block. Patients are then repositioned supine for surgery.
• Другое Immediate Supine Positioning
  After spinal anesthesia with 12 mg of 0.5% hyperbaric bupivacaine administered in the sitting position, patients are immediately placed in the supine position. This results in bilateral distribution of the hyperbaric local anesthetic and serves as the active comparator.

Первичные конечные точки

• Incidence of Hypotension [Срок оценки: From spinal anesthesia to 15 minutes after administration]

Вторичные конечные точки (5)

• Incidence of Bradycardia [Срок оценки: From spinal anesthesia to 30 minutes after administration]
• Ephedrine Requirement [Срок оценки: From spinal anesthesia to 30 minutes after administration]
• Atropine Requirement [Срок оценки: From spinal anesthesia to 30 minutes after administration]
• Maximum Sensory Block Level [Срок оценки: From spinal anesthesia to 30 minutes after administration]
• Incidence of Unilateral Sensory Block [Срок оценки: 15 and 30 minutes after spinal anesthesia administration]

Критерии участия

Критерии включения

• Age 65 years or older
• ASA physical status classification III or IV
• Scheduled for unilateral lower extremity orthopedic surgery (hip fracture, femur fracture, knee arthroplasty, tibia-fibula fracture, or similar procedures)
• Eligible for spinal anesthesia
• Written informed consent obtained

Критерии исключения

• Contraindications to spinal anesthesia (coagulopathy, recent anticoagulant or antiplatelet use without adequate washout period, local infection at injection site)
• Severe neurological disease or pre-existing motor or sensory deficit
• Significant spinal deformity (severe scoliosis, kyphosis) or history of previous spinal surgery
• Known allergy to local anesthetics
• Decompensated heart failure (ejection fraction below 30%)
• Uncontrolled hypertension (systolic blood pressure above 180 mmHg or diastolic blood pressure above 110 mmHg)
• Emergency surgery
• Severe hypovolemia or active bleeding
• Advanced dementia or inability to communicate
• Body mass index above 40 kg/m²
• Refusal to participate

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Профилактика

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• Kelly JD, McCoy D, Rosenbaum SH, Brull SJ. Haemodynamic changes induced by hyperbaric bupivacaine during lateral decubitus or supine spinal anaesthesia. Eur J Anaesthesiol. 2005 Sep;22(9):717-22. doi: 10.1017/s0265021505001183. PMID 16163920
• Simonin M, Delsuc C, Meuret P, Caruso L, Deleat-Besson R, Lamblin A, Huriaux L, Abraham P, Bidon C, Giai J, Riche B, Rimmele T. Hypobaric Unilateral Spinal Anesthesia Versus General Anesthesia for Hip Fracture Surgery in the Elderly: A Randomized Controlled Trial. Anesth Analg. 2022 Dec 1;135(6):1262-1270. doi: 10.1213/ANE.0000000000006208. Epub 2022 Sep 22. PMID 36135347
• Guay J, Parker MJ, Gajendragadkar PR, Kopp S. Anaesthesia for hip fracture surgery in adults. Cochrane Database Syst Rev. 2016 Feb 22;2(2):CD000521. doi: 10.1002/14651858.CD000521.pub3. PMID 26899415
• Gill TM, Vander Wyk B, Leo-Summers L, Murphy TE, Becher RD. Population-Based Estimates of 1-Year Mortality After Major Surgery Among Community-Living Older US Adults. JAMA Surg. 2022 Dec 1;157(12):e225155. doi: 10.1001/jamasurg.2022.5155. Epub 2022 Dec 14. PMID 36260323
• Becher RD, Vander Wyk B, Leo-Summers L, Desai MM, Gill TM. The Incidence and Cumulative Risk of Major Surgery in Older Persons in the United States. Ann Surg. 2023 Jan 1;277(1):87-92. doi: 10.1097/SLA.0000000000005077. Epub 2021 Jul 14. PMID 34261884

Идентификаторы

NCT: NCT07597148 · hasanduman2

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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