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临床试验/CTRI/2025/08/093926
CTRI/2025/08/093926尚未招募不适用

Role of Perfusion Index and Pleth Variability Index as predictors of hypotension following spinal anaesthesia in patients undergoing infraumbilical surgeries.

Dr BR Ambedkar Medical College1 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2025年9月12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
62
试验地点
1
主要终点
To evaluate the efficacy of Perfusion Index (PI) and Pleth variability index (PVI) to detect hypotension following Spinal anaesthesia

研究概览

简要总结

The baseline PI and PVI will be monitored with the help of Massimo Pulse oximeter by an anaesthesiologist. The PI and PVI will be recorded every 10 seconds for one minute in a supine position on the right index finger at room temperature. The NIBP cuff will always put on the opposite arm. The blood pressure (BP) and HR will be recorded at an interval of one minute for three minutes. The mean of PI, BP, and HR will be taken as the preoperative value.

The patients will then be transferred to the operation theater and standard monitors will be attached, such as electrocardiogram, NIBP, and Massimo pulse oximetry. IV fluid started for the patient at 1.5ml/kg/hr. Spinal anesthesia will be administered by an anaesthesiologist using Quicke’s 25-gauge needle with 15 mg (3 ml) of 0.5% hyperbaric bupivacaine at L3- L4 interspace in the sitting position. The sensory block level will be maintained between T6 and T7 by adjusting the table position. After 20 minutes of spinal anesthesia, maximum cephalad spread will be monitored. If the MAP dropped more than 20% of preoperative reading or when the MAP <60 mmHg (whichever is greater), then it will be regarded as hypotension and treated with a bolus of 6 mg intravenous ephedrine hydrochloride. Bradycardia defined as HR of less than 50 beats/minute and will be managed with 0.6 mg of IV atropine.

The PI, PVI, HR, BP, and SpO2 will be monitored continuously and recorded at five-minute intervals till the end of surgery.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • Patient aged from 18 to 80 years undergoing elective infra umbilical surgeries under spinal anaesthesia belonging to American Society of Anaesthesiologists Physical Status (ASA-PS) I and II.

排除标准

  • Patients who are k/c/o of Hypertension on medication • Patients with known cardiac comorbidities, abdominal mass.
  • • Pregnancy • Patients with contraindication for Spinal Anaesthesia.
  • • Patients not willing to participate in the study.

结局指标

主要结局

To evaluate the efficacy of Perfusion Index (PI) and Pleth variability index (PVI) to detect hypotension following Spinal anaesthesia

时间窗: Every 5 minute interval till end of surgery

次要结局

  • To study the hemodynamic changes in correlation with change in Perfusion index (PI) & Pleth Variability Index (PVI),and To study the effect of Ephedrine bolus on Perfusion index (PI) & Pleth Variability Index (PVI) to understand response to sympathomimetic drugs.

研究者

发起方
Dr BR Ambedkar Medical College
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

DR M SALIM IQBAL

Dr. B.R. Ambedkar Medical College

研究点 (1)

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