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临床试验/CTRI/2024/05/066637
CTRI/2024/05/066637已完成不适用

Utility of Pleth Variability Index (PVI) in Predicting Spinal anaesthesia-induced hypotension in elderly patients: A prospective diagnostic test study

Post Graduate Institute of Medical Education ResearchChandigarh1 个研究点 分布在 1 个国家目标入组 108 人开始时间: 2024年5月14日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
108
试验地点
1
主要终点
• To determine the predictive value of Pleth variability index (PVI) at the end of a 15-sec maximal inspiratory breath hold in the sitting position before spinal anaesthesia in predicting the occurrence of hypotension, defined as a fall in MAP by 20% from baseline or SBP less than 80 mm of Hg in elderly patients.

研究概览

简要总结

After approval from the Institutional Ethics Committee, PGIMER, Chandigarh, written informed consent will be obtained from all the patients before enrollment in this prospective diagnostic study.

 Pre anaesthesia evaluation

 Â· All the patients will undergo standard pre-anaesthesia checkups along with breath-holding time. Those patients who meet the inclusion and exclusion criteria will be included in the study.

 Before spinal anaesthesia

 Â·      Once the participant enters the operating theatre, he/she will be asked to lie supine on the table. Concurrently, the ASA (American Society of Anaesthesiologists) standard monitors and the Masimo Radical 7® (Masimo Corp., Irvine, CA, USA) devices will be attached to the patient within the operating room premises. A warming device will also be applied to the patient, and the preoperative fasting period will be recorded.

 Â·      Baseline parameters such as heart rate (HR), systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP), temperature, as well as baseline perfusion index (PI), and pleth variability index (PVI), will be recorded following a five-minute resting period.

 Â·      Subsequently, the individual will be instructed to perform a breathing manoeuvre by taking a deep exhalation followed by a peak inhalation and a 15-second breath hold immediately before administering spinal anaesthesia. We will record the second Pleth Variability Index (PVI) at this juncture.

 Â·      After recording 2nd PI and PVI values, intravenous crystalloid infusion will be started at the rate of 2 millilitres per kilogram per hour, will be initiated.

 Administration of spinal anaesthesia

 Â·      Under appropriate aseptic precautions, in the sitting position, the patient’s back will be painted with an antiseptic solution and draped. The antiseptic solution will be left to dry for a few minutes.

 Â·      Meanwhile, the drug (Heavy Bupivacaine 10mg + Fentanyl 25 mcg) will be loaded in a syringe for intrathecal injection, maintaining sterile conditions. L4-L5 intervertebral space will be identified using Tuffier’s line as a landmark that passes from the highest point on the iliac crests.

 Â·      Using 25G/26G Quincke’s spinal needle, a needle will be inserted in L3-L4 or L4-L5 intervertebral space through a midline or paramedian approach.

 Â·      After the free flow of CSF is seen, the syringe will be locked tightly to the spinal needle, and the drug will be administered intrathecally to the patient in the L3-L4  or L4-L5 intervertebral space.

 After spinal anaesthesia

·      After administration of sub-arachnoid block, NIBP(Non-invasive blood pressure) measurements will be cycled every 2 minutes for 10 minutes, followed by every 5 minutes till 30 minutes from spinal drug injection. The highest level of sensory and motor block will also be recorded.

·      A fall in MAP by 20% from baseline or SBP less than 80 mm of Hg at any of these time points will be considered anaesthesia-induced hypotension.

·      The hypotensive episode will be treated with an intravenous fluid bolus of 250 ml followed by phenylephrine 0.1 mics per Kg or Mephenteramine 3 to 6 mg boluses based on the heart rate and ongoing intravenous fluids if the hypotensive episode continues.

·      Duration of surgery and total intravenous fluid will also be documented.

研究设计

研究类型
Observational

入排标准

年龄范围
60.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • 1.Patient undergoing spinal or spinal-epidural anaesthesia 2.ASA-PS I/II 3.Patients undergoing elective surgery.

排除标准

  • 1.BMI more than 35 kg/m2 2.Pre-existing hypotension or shock 3.Any contraindication to spinal anaesthesia 4.Cardiac dysfunction (EFless than 40%, arrhythmias) 5.Known peripheral vascular disease/vasculitis 6.Patients with less than 15-sec breath holding time • Failed spinal anaesthesia.

结局指标

主要结局

• To determine the predictive value of Pleth variability index (PVI) at the end of a 15-sec maximal inspiratory breath hold in the sitting position before spinal anaesthesia in predicting the occurrence of hypotension, defined as a fall in MAP by 20% from baseline or SBP less than 80 mm of Hg in elderly patients.

时间窗: Baseline and every 2 minutes for 10 minutes, followed by every 5 minutes till 30 minutes from spinal drug injection.

次要结局

  • 1. To determine the predictive value of change in PVI (baseline & after 15 sec breath hold) & occurrence of post-spinal hypotension in elderly patients.(2. To determine the predictive value of baseline PI in the development of hypotensive response to spinal anaesthesia.)

研究者

发起方
Post Graduate Institute of Medical Education ResearchChandigarh
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Sujeet Sagar

Post Graduate Institute of Medical Education and Research, Chandigarh

研究点 (1)

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