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临床试验/CTRI/2026/03/106278
CTRI/2026/03/106278尚未招募4 期

To evaluate the efficacy of prophylactic intravenous dexamethasone in attenuating postspinal hypotension in geriatric patients undergoing lower limb orthopaedic surgery- A randomised controlled double blind study

Pt. B.D. Sharma PGIMS Rohtak1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2026年3月28日最近更新:

试验速览

阶段
4 期
状态
尚未招募
入组人数
70
试验地点
1

研究概览

简要总结

Post-spinal hypotension is a common complication following spinal anaesthesia, particularly in elderly patients, due to decreased sympathetic tone and impaired compensatory cardiovascular responses. This may lead to adverse outcomes if not promptly managed. Various preventive strategies including fluid loading and vasopressors have been used; however, these may be associated with undesirable side effects. Dexamethasone, a commonly used corticosteroid, may attenuate spinal-induced hypotension by reducing activation of the Bezold–Jarisch reflex and enhancing vascular responsiveness to vasoconstrictors.

This prospective, randomized, double-blind, placebo-controlled study aims to evaluate the efficacy of prophylactic intravenous dexamethasone in reducing the incidence of post-spinal hypotension in geriatric patients undergoing lower limb orthopaedic surgery under spinal anaesthesia. Seventy patients aged 65 years or older will be randomly allocated to receive either intravenous dexamethasone or placebo prior to spinal anaesthesia. Hemodynamic parameters, vasopressor requirement, intravenous fluid administration, and adverse events will be recorded and compared between the two groups.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant, Investigator and Outcome Assessor Blinded

入排标准

年龄范围
65.00 Year(s) 至 90.00 Year(s)(—)
性别
All

入选标准

  • Patients belonging to the American Society of Anaesthesiologists-Physical Status I to III and aged 65 years or more of either sex, undergoing lower limb orthopaedic surgery under spinal anaesthesia will be included in the study.

排除标准

  • The following patients will be excluded from the study:Patients refusing to give consent;Patients having spinal deformity, contraindications to spinal anesthesia (coagulopathy, thrombocytopenia, allergy to local anesthetics);Patients with known hypersensitivity to dexamethasone;Patients on chronic corticosteroid therapy, SSRI, antihypertensive drugs; BMImore than 30 kg per m2; Patients with cardiac diseases.

研究者

申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Anju Rani

Pt.B.D. Sharma PGIMS Rohtak

研究点 (1)

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