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临床试验/CTRI/2025/07/090706
CTRI/2025/07/090706尚未招募不适用

Study of perioperative hemodynamic parameters in elderly patients undergoing hip surgery under spinal anesthesia: Comparison between frail and non-frail groups

Goverment Of West Bengal1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年8月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
100
试验地点
1
主要终点
To compare hemodynamic changes ( mean arterial pressure ,heart rate ,and ST changes) between frail and non frail groups undergoing hip surgery under spinal anaesthesia

研究概览

简要总结

Frailty is defined as a state of vulnerability due to reduced physiological reserve that predisposes the patients to adverse outcomes from different types of stress including surgery. Frailty is measured by frailty index (FI). The principle of this index is to count the deficits in health (which can be symptoms, signs, diseases, disabilities or laboratory, radiographic or electrocardiographic abnormalities). The index is expressed as a ratio of deficits present to the total number of deficits considered. FI<0.12 is considered non frail, 0.12-0.24 is considered mild frail, 0.24- 0.36 is moderate frail and index more than 0.36 is regarded as severely frail. Intra-operative complication that occurs most commonly in the frail patients includes hypotension that requires vasopressor or blood transfusion. Evidence on intraoperative hemodynamic instability in frail patients is particularly limited.

After approval of CTRI, all elderly patients (age>65-85 years) planed for unilateral hip surgery under spinal anesthesia over the next one year will undergo pre anesthetic check up by history taking, clinical examinations and investigations. National Early Warning Score (NEWS) will be assessed in each patient depending on the clinical examination. Patients having score <5 will be assessed for eligibility. Frailty index (FI) will be calculated based on the deficits (Table 2). Depending on the FI value, patients will be allocated in three groups after written informed consent; Group NF (Non-frail), group MiF (mild frail) and group MoF (moderate frail).

In all patient subarachnoid block will be performed at L3-4 or L4-5 inter space in sitting position with 0.5% hyperbaric bupivacaine (1.5 ml) and fentanyl 25 mcg. Intraoperative MAP, HR and ST changes will be compared at every 3 min interval for 30 min, thereafter at 5 min interval till the end of surgery. Post operatively vitals will be recorded at 30 min interval for 6 hours. Incidence of hypotension, bradycardia or other complications will be recorded.

As there is no previous study comparing hemodynamic changes in different types of frail patients, outcome will be evident only after the completion of the study.

研究设计

研究类型
Observational

入排标准

年龄范围
65.00 Year(s) 至 85.00 Year(s)(—)
性别
All

入选标准

  • Patient with unilateral hip fracture ASA I II III Scheduled for spinal anesthesia Mentally fit to give written informed consent.

排除标准

  • NEWS more than 5 Severely frail patient Surgical time more than 2 hours Patient planned for total hip replacement Patient having pelvic bone or acetabular fracture Contraindications of spinal anesthesia Conversion to general anesthesia.

结局指标

主要结局

To compare hemodynamic changes ( mean arterial pressure ,heart rate ,and ST changes) between frail and non frail groups undergoing hip surgery under spinal anaesthesia

时间窗: To compare mean arterial pressure ,heart rate ,and ST changes between frail and non frail groups every 3 min for first 30 min. Thereafter at 5 min interval till the end of the surgery. | Post operatively vitals will be recorded at 30 min interval for 6 hours

次要结局

  • To compare height & duration of sensory & motor block(To compare the incidence of complication if any)

研究者

发起方
Goverment Of West Bengal
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Manish kumar

Midnapore Medical College

研究点 (1)

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