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临床试验/CTRI/2025/02/081190
CTRI/2025/02/081190尚未招募4 期

COMPARING THE INCIDENCE OF SPINAL HYPOTENSION IN ELECTIVE LSCS CASES WITH DIFFERENT VALUES OF PERFUSION INDEX IN PULSE OXIMETRY –AN OBSERVATIONAL PROSPECTIVE STUDY

Chettinad hospital and research insitute1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年3月3日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
To Compare the association of post spinal hypotension in

研究概览

简要总结

Spinal anesthesia for lower segment cesarean section (LSCS) is one of the most common procedures.  Prediction of patients likely to develop hypotension will ensure effective prevention and prompt management, which is of paramount importance for the best quality care. • Various parameters have been studied to predict hypotension after spinal anesthesia but a precise indicator was not established  Parameter we will be using in this study is Perfusion index from pulse oximetry Perfusion index (PI) is a non invasive, continuous, photo plethysmographic pulse wave monitored from a pulse oximeter .It is defined as the ratio of pulsatile blood flow to non pulsatile blood flow in peripheral vascular tissue and the value ranges between 0.02% and 20% In parturients, at term, due to decreased peripheral vascular tone, blood volume is pooled in the extremities, which increases further after sympathetic blockade of spinal anesthesia resulting in hypotension.  Parturients with high baseline PI are expected to have lower peripheral vascular tone and hence are at higher risk of developing hypotension following spinal anesthesiaAll the studies have used different baseline perfusion index with varying results .I would like to use baseline perfusion index of 2.9and two groups (Group 1 –PI < 2.9 and Group >2.9)which has increased sensitivity(83%) and specificity (96%) according to the study - Harde MJ, Ranale PB, Fernandes S. Perfusion index to predict post spinal hypotension in lower segment caesarean section. J Anaesthesiol Clin Pharmacol 2024;40:37-42.

Study Objectives

AIM Predicting spinal hypotension in elective LSCS cases using perfusion Index in pulse oximetry

PRIMARY OBJECTIVE To Compare the association of post spinal hypotension in elective LSCS in two groups with different perfusion index

SECONDARY OBJECTIVE To assess the use of vasopressors (Phenylepineprine)in number of patients in both group with spinal hypotension

Study design- AN OBSERVATIONAL PROSPECTIVE STUDY

Number of subjects/sample size

The sample size suggested for the present study is 30 in each group Group 1(PI < 2.9) -30 Participants Group 2(PI >2.9)-30 Participants Study Methodology or procedure

Inclusion criteria

Study participants with ASA Grade 2

Age group of the study participants 18- 35 years

Pregnant mothers with singleton fetus

Elective LSCS

Patient Height-150- 180cm

Exclusion criteria

Asa 3 and 4  Emergency cases

Body mass index >40

Paturients with placenta previa,

Cardio and Cerebro vascular disease

Preeclampsia and Eclampsia patients

Peripheral vascular disease

After obtaining apporoval from Ethics comitee  Informed and Written consent Will be obtained from all patients  All patients will be instructed to fast for 8 hrs for solid diet prior to surgery  All patients will be pre medicated with Tab.Metaclopromide 10 mg and Tab Ranitidine 150 mg orally on the night before surgery and morning of surgery  Patients baseline pre operative vitals will be recorded ( HR, BP, MAP, SPO2 and perfusion index )  An intravenous (IV) line will be established with an 18 G IV catheter in the dorsum of hand or wrist vein  All the patients are pre loaded with Lactated ringer’s(RL) solution of 10ml /kg(Approximately 500 ml)  Standard monitoring with electrocardiography, non invasive blood pressure, pulse oximetry with perfusion index will be performed as per ASA guidelines  BP, MAP, HR, SPO2, PERFUSION INDEX will be monitored  Under sterile aseptic precautions all patients will receive sub arachanoid block at L3-L4 or L4-L5, level with patients in sitting or lateral position using 25 or 26 G Quincke needle  After cerebrospinal fluid is detected Inj 0.5 Bupivacaine(Hyperbaric) 10mg with 60 mcg of buprenorphine is administered  Oxygen will be attached by use of face mask at 4 L/min to parturient after returned to supine position.  By use of a cold swab level of sensory block will be checked 5 min after spinal injection before starting surgery.  Heart rate (HR), Systolic blood pressure (SBP), Diastolic blood pressure (DBP), Mean arterial pressure (MAP), perfusion index (PI), saturation (SpO2) & respiratory rate(RR) will be recorded at 2 min intervals till the delivery of baby & then 10 min intervals till the end of surgery after the SAB  Decrease in Mean arterial pressure (MAP) of <60 will characterized as hypotension  Hypotension will be treated with IV fluid (Ringer lactate solution),if required vasopressors (Phenylepiphrine ).Total amount of vasopressors used will be noted

Pearsons correlation will be used to asses correlation between baseline Perfusion index and hypotension

Study outcome or end points - Compare the different values of perfusion index in pulse oximetry to predict spinal hypotension in elective LSCS cases and prevent it effectively

Ethical Considerations- Approval from Chettinad Hospital and Research Institute IHEC (institutional human ethical committee) will be obtained before starting the study. All participants will be informed regarding the purpose of study, benefits, procedure and confidentiality of the research study in their local language and in English. An informed and written consent will be taken from person who willing to participate in study

Study Duration (in Months / Years)- 2 year

References

.  Minal J. Harde, Prashant B. Ranale, Sarita Fernandes.Perfusion index to predict post spinal hypotension in lower segment caesarean section DOI: 10.4103/joacp.joacp_178_22

Preoperative baseline peripheral perfusion index as an early predictor of the incidence of hypotension following spinal anaesthesia in elective caesarean section. simi. p. babu , ashwini. b , balasandhiya DOI: 10.47009/jamp.2024.6.2.72

study to evaluate perfusion index as a predictor of hypotension following spinal anesthesia for caesarean section Jatin Lal, Teena Bansal, Shweta Bhardwaj, Mamta Jain, Anish Kumar Singh DOI: 10.4103/joacp.JOACP_385_20

A study to evaluate perfusion index as a predictor of hypotension following spinal anesthesia for caesarean section Jatin Lal, Teena Bansal, Shweta Bhardwaj, Mamta Jain, Anish Kumar Singh DOI: 10.4103/joacp.JOACP_385_26

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 35.00 Year(s)(—)
性别
Female

入选标准

  • Study participants with ASA Grade 2 Age group of the study participants 18-35 years Pregnant mothers with singleton fetus Elective LSCS Patient Height-150-180CM.

排除标准

  • ASA 3 and 4 patients with eclampsia and preeclampsia patient with cardiovascualr disease patient with eclampsia and pre eclmapsia.

结局指标

主要结局

To Compare the association of post spinal hypotension in

时间窗: At baseline and till the end of surgery (120 mins )

elective LSCS in two groups with different perfusion index

时间窗: At baseline and till the end of surgery (120 mins )

次要结局

  • To assess the(use of vasopressors (Phenylepineprine)in number of patients in both group with spinal)

研究者

发起方
Chettinad hospital and research insitute
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

DRMANIKANDANP

Chettinad hospital and research institute

研究点 (1)

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