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临床试验/CTRI/2024/04/064948
CTRI/2024/04/064948尚未招募不适用

Perfusion index from pulse oximetry as a predictor of incidence of hypotension following spinal anaesthesia with Levobupivacaine 0.5%(heavy) in lower segment caesarean section .

Bharat Ratna Late Shri Atal Bihari Vajpayee Memorial Medical CollegeRajnandgaonChhattisgarh1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2024年4月10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
120
试验地点
1
主要终点
Baseline PI and its correlation with intraoperative SBP,DBP and MAP

研究概览

简要总结

STUDY TITLE: Perfusion index from pulseoximetry as a predictor of hypotension following spinal anaesthesia with levobupivacaine 0.5%(Heavy) in lower segment Caesarean section.

RATIONALE:  Can perfusion index(PI) be used as a factor for predicting intraoperative hypotension in Caesarean section patients?

AIM:  To predict hypotension in patients induced with 0.5% levobupivacaine (heavy) based on their baseline perfusion index (PI) values measured preoperatively .

OBJECTIVES: Prediction of hypotension in caesarean section under spinal anaesthesia using perfusion index.

SETTING:  B.R.L.S.A.B.V.M Medical College, Rajnandgaon.

STUDY DESIGN : Prospective observational study

TIME FRAME : 3 months , Prospective Study starting from 01/04/2024 to 30/06/24

POPULATION/ PARTICIPANTS :Patients scheduled for elective Caesarean section at B.R.L.S.A.B.V.M. Medical College, Rajnandgaon.

SAMPLE SIZE: 120

METHODS: Studies have shown that baseline PI > 3.5 has high predictability for intraoperative hypotension in parturients undergoing elective caesarean section under spinal anesthesia with Bupivacaine 0.5% (Heavy) . Hence we are doing this study with Levobupivacaine 0.5 %(Heavy) to see correlation between baseline PI values and intraoperative hypotension in patients undergoing elective LSCS .  Parturients undergoing elective caesarean delivery under spinal anaesthesia with hyperbaric Levobupivacaine (0.5%) will be enrolled in the study . The correlation between baseline PI and degree of hypotension during LSCS under spinal anaesthesia will be observed .  Predictability of spinal anaesthesia induced hypotension during Caesarean delivery by baseline PI will be evaluated .

OUTCOME MEASURES:

**Outcome :**Baseline PI and its correlation with intraoperative  SBP,DBP and MAP

STATISTICS

Descriptive statistics will be analysed with SPSS version 20.0 software .continuous variables will be presented as mean +-SD.

●Categorical variables will be expressed as frequencies and percentages.

●The Pearson’s chi square test or the chi square test of association will be used to determine if there isa relationship between 2 categorical variables.Spearman/Pearson correlation will be used to determine correlation in case of continuous variables.A p value less than 0.5. Will be considered statistically significant.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 40.00 Year(s)(—)
性别
Female

入选标准

  • Inclusion criteria includes : 1.
  • 40years age 2.Term pregnant patients 3.ASA II 4.Elective cases 5.Height :150-160cm.

排除标准

  • 1.Emergency cases 2.Antepartum haemorrhage 3.Postpartum haemorrhage 4.Endocrine diseases including GDM and thyroid disorders 5.Gestational hypertension/ PIH/ Preeclampsia 6.Cardiovascular or cerebrovascular disease 7.Morbid obesity with a BMI more than40 8.Gestational age less than 37 or more than 40 weeks 9.Contraindications to spinal anesthesia 10.Foetus with known congenital anomalie.

结局指标

主要结局

Baseline PI and its correlation with intraoperative SBP,DBP and MAP

时间窗: SBP,DBP,MAP,Respiratory rate,SpO2,PI are noted at 0,2,3,5,7 ,10minutes and then every 5minutes till the end of surgery

次要结局

  • Incidence of other side effects(Till the end of surgery)

研究者

发起方
Bharat Ratna Late Shri Atal Bihari Vajpayee Memorial Medical CollegeRajnandgaonChhattisgarh
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Daleena Nelson

Bharat Ratna Late Shri Atal Bihari Vajpayee Memorial Medical College,Rajnandgaon,Chhattisgarh

研究点 (1)

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