Comparison of Low-Dose Versus Standard-Dose Hyperbaric Bupivacaine in Spinal Anesthesia

Официальное название

Comparison of Low-Dose Versus Standard-Dose Hyperbaric Bupivacaine in Spinal Anesthesia: Hemodynamic Stability and Recovery Profile in Elderly Patients Undergoing Lower Limb Orthopedic Surgery

Обзор

The goal of this randomized controlled trial is to determine whether low-dose hyperbaric bupivacaine provides better hemodynamic stability and postoperative recovery compared with standard-dose hyperbaric bupivacaine in elderly patients undergoing lower limb orthopedic surgery under spinal anesthesia. The main questions it aims to answer are: * Does low-dose hyperbaric bupivacaine reduce the incidence of intraoperative hypotension and bradycardia compared with standard-dose hyperbaric bupivacaine? * Does low-dose hyperbaric bupivacaine improve postoperative recovery profile compared with standard-dose hyperbaric bupivacaine? Researchers will compare elderly patients receiving low-dose hyperbaric bupivacaine with those receiving standard-dose hyperbaric bupivacaine to determine whether a lower intrathecal dose improves cardiovascular stability and recovery without compromising the effectiveness of spinal anesthesia. Participants will: * Provide written informed consent before enrollment. * Undergo elective lower limb orthopedic surgery under spinal anesthesia. * Be randomly assigned to receive either low-dose or standard-dose hyperbaric bupivacaine. * Have their blood pressure, heart rate, and other vital signs monitored throughout the surgical procedure. * Be assessed for intraoperative hypotension and bradycardia according to predefined study criteria. * Be evaluated for postoperative recovery parameters, including motor recovery and readiness for postoperative recovery and mobilization. The information obtained from this study may help identify a safer and more effective spinal anesthetic technique for elderly patients undergoing orthopedic surgery.

Вмешательства

• Препарат Low-Dose Hyperbaric Bupivacaine
  Low-dose hyperbaric bupivacaine administered intrathecally for spinal anesthesia in elderly patients undergoing elective lower limb orthopedic surgery.
• Препарат Standard-Dose Hyperbaric Bupivacaine
  Standard-dose hyperbaric bupivacaine administered intrathecally for spinal anesthesia in elderly patients undergoing elective lower limb orthopedic surgery.

Первичные конечные точки

• Incidence of Intraoperative Hypotension [Срок оценки: From administration of spinal anesthesia until completion of surgery]

Вторичные конечные точки (4)

• Incidence of Intraoperative Bradycardia [Срок оценки: From administration of spinal anesthesia until completion of surgery.]
• Time to Complete Motor Recovery [Срок оценки: From completion of surgery until achievement of Bromage Score 0, assessed up to 24 hours postoperatively]
• Time to First Ambulation [Срок оценки: Within the first 24 hours after surgery]
• Postoperative Recovery Profile [Срок оценки: From completion of surgery until discharge from the post-anesthesia care unit (PACU), assessed up to 24 hours postoperatively]

Критерии участия

Критерии включения

• Male or female patients aged 65 years and above.
• Patients scheduled for elective lower limb orthopedic surgery under spinal anesthesia.
• American Society of Anesthesiologists (ASA) physical status I-III.
• Patients willing to participate and provide written informed consent.

Критерии исключения

• Refusal to participate in the study.
• Contraindications to spinal anesthesia (e.g., infection at puncture site, coagulopathy, severe hypovolemia, raised intracranial pressure).
• Known hypersensitivity or allergy to bupivacaine.
• Severe valvular heart disease.
• Significant cardiac arrhythmias.
• Uncontrolled hypertension.
• Severe hepatic or renal impairment.
• Pre-existing neurological disorders affecting lower limb motor or sensory function.
• Severe spinal deformity or previous lumbar spine surgery interfering with spinal anesthesia.
• Cognitive impairment or inability to provide informed consent.
• Emergency orthopedic procedures.

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

Двойное слепое

Основная цель

Лечение

Центры проведения

Пакистан · 1 центр

• Mayo Hospital, Lahore — Lahore

Публикации

• Lee YY, Ngan Kee WD, Muchhal K, Chan CK. Clinical comparison of 12 mg ropivacaine and 8 mg bupivacaine (with fentanyl) in spinal anaesthesia for major orthopaedic surgery in geriatric patients. Acta Anaesthesiol Scand. 2011;55(3):298-303
• Ben-David B, Frankel R, Arzumonov T, Marchevsky Y, Volpin G. Minidose bupivacaine-fentanyl spinal anesthesia for surgical repair of hip fracture in the aged. Anesthesiology. 2000 Jan;92(1):6-10. doi: 10.1097/00000542-200001000-00007. PMID 10638892
• Patel A, Yadav AK, Patel PS, Kumari R, Deepesh. Comparative hemodynamic stability in low-dose versus conventional-dose bupivacaine for spinal anaesthesia in elderly patients. Int J Pharm Res Technol. 2025;15(2). doi:10.31838/ijprt/15.2.89.

Идентификаторы

NCT: NCT07684989 · Mayo_ANS_01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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