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临床试验/NCT05896631
NCT05896631已完成不适用

The Effect of Spinal Anesthesia Methods on Hemodynamics in Geriatric Patients

Ankara City Hospital Bilkent1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2023年6月8日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
80
试验地点
1
主要终点
hemodynamic variability

研究概览

简要总结

In this study, it was planned to provide more stable hemodynamics in geriatric patients with low-dose spinal anesthesia. We will compare 7.5mg hyperbaric bupivacaine with 5mg hyperbaric bupivacaine.

The researchers hypothesized that low-dose bupivacaine would provide adequate anesthesia, less hypotension, and faster recovery.

详细描述

Hypothesis It is hypothesized that low-dose bupivacaine can provide adequate anesthesia, less hypotension, and faster recovery.

patient population Patients over 65 years of age who will undergo spinal anesthesia due to hip fracture.

Hemodynamic data(Blood pressure-mmHg, heart rate-beats per minute) of patients, bromage scores, perfusion index (PI) values, discharge time, pain with NRS (numerical rating scale), patient satisfaction will be evaluated ( Numeric output from 1-10).

Hemodynamic variables will be recorded every 2 minutes in the first 20 minutes after spinal anesthesia. hemodynamic variables will be recorded 30 minutes after spinal anesthesia and at the end of the operation.

The perfusion index is the ratio of the blood volume to the pulsatile to non-pulsatile fraction. An increase in the pulsatile fraction that occurs during vasodilation corresponds to a higher PI. Therefore, patients with a higher PI have a higher risk of post-spinal hypotension.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Participant)

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •ASA(American Society of Anesthesiologists) I-II-III patients
  • •BMI( body mass index) in the range of 18-40
  • •over 65 years old hip fracture

排除标准

  • •Refusal to participate in the study
  • •Left ventricular ejection fraction below 40%
  • •cardiac arrhythmia
  • •Patients with peripheral vascular disease
  • •Failure of spinal anesthesia

研究组 & 干预措施

7.5 mg hyperbaric bupivacaine

Active Comparator

Patients undergoing spinal anesthesia in the lateral decubitus position with 7.5 mg of hyperbaric bupivacaine will be included.

干预措施: 7.5 mg hyperbaric bupivacaine (Other)

5 mg hyperbaric bupivacaine

Active Comparator

Patients undergoing spinal anesthesia in the lateral decubitus position with 5 mg of hyperbaric bupivacaine will be included.

干预措施: 5 mg hyperbaric bupivacaine (Other)

结局指标

主要结局

hemodynamic variability

时间窗: at 30 minutes of spinal anesthesia

intraoperative hemodynamic variables (BP(blood pressure-mmHg) during hip surgery

hemodynamic variability

时间窗: every 2 minutes for the first 20 minutes after spinal anesthesia

intraoperative hemodynamic variables (BP(blood pressure-mmHg) during hip surgery

次要结局

  • Sensory Levels(24 hours)
  • ephedrine use(24 hours)
  • fentanyl use(24 hours)
  • bromage scale(24 hours)
  • perfusion index variability(at the end of the operation)
  • NRS(numerical rating scale)(24 hours)
  • perfusion index variability(every 2 minutes for the first 20 minutes after spinal anesthesia)
  • perfusion index variability(at 30 minutes of spinal anesthesia)
  • NRS(numerical rating scale)(2 hours)
  • NRS(numerical rating scale)(8 hours)
  • NRS(numerical rating scale)(16 hours)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Fatma Kavak Akelma

Anesthesiology and reanimation assistant doktor

Ankara City Hospital Bilkent

研究点 (1)

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