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临床试验/CTRI/2025/10/095970
CTRI/2025/10/095970尚未招募不适用

Prediction of incidence of spinal hypotension using perfusion index from pulse oximetry of right and left toes in LSCS patients- A prospective Observational study

Dr Aswini Gandhimathi R1 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2025年11月5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
84
试验地点
1
主要终点
To predict the incidence of post spinal hypotension from toe perfusion index of lower segment cesarean section patients.

研究概览

简要总结

To Predict the incidence of spinal hypotension using  perfusion index from pulse oximetry of right and left toes in Lower segment cesarean section patients- A prospective Observational study

Primary objective:

To predict the incidence of post spinal hypotension from toe perfusion index of lscs patients.

Secondary objective:

To explore the correlation between toe Perfusion index and spinal hypotension and determine cut off value if any through ROC curves.

To assess the relationship between changes in the perfusion index in the right and left toe and incidence of post spinal hypotension

To analyse the differential perfusion index of upper limb and lower limb

Inclusion criteria

Age 18-40yrs

Pregnant mothers with singleton fetus

Elective and Emergency LSCS

Patient Height- 150 to180cm

Exclusion criteria

parturient age less than or equal to 18 years or more than or equal to 40 years

Body mass index more than 40

Parturient with placenta previa

Eclampsia and pre-eclampsia

cardiovascular or cerebrovascular disease

Peripheral vascular disease

Methodology:

After obtaining approval from Ethics committee. Informed and Written consent will be obtained from all patients .All patients will be instructed to fast  for  8 hours for solid diet prior to surgery. All patients will be pre medicated with Tablet Metaclopromide 10 mg  and Tab. Ranitidine 150 mg orally on the night before surgery and morning of surgery. Patients 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 patients will be coloaded with Lactated ringer’s(RL) solution of approximately 500 ml. Standard monitoring with electrocardiography, non invasive blood pressure, pulse oximetry with perfusion index will be performed as per ASA guidelines .Baseline BP, MAP, HR, SPO2, PERFUSION INDEX  will be monitored and noted. Pulse oximeter will be put on the left hand and right and left second toes of parturients in supine position for continuous monitoring of toe and hand perfusion index until the fetus is delivered .The perfusion index of upper limb and right and left toe will be noted 5mins before spinal anasthesia in supine position. Under sterile aseptic precautions all patients will receive subarachanoid block at L3-L4 or L4-L5, level with patients in sitting position using 25 or 26 G Quincke needle. After cerebrospinal fluid is detected Inj 0.5% Bupivacaine(Hyperbaric)2ml with buprenorphine 0.2ml is administered.By use of a cold swab level of sensory block will be checked 5 min after spinal injection before starting surgery. Oxygen will be attached by use of face mask at 4 L/min to parturient after returned to supine position. After spinal anaesthesia, 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 3 min intervals till the delivery of baby.The perfusion index of left hand and right and left toe will be noted 5mins after spinal anesthesia in supine position. Decrease in Systolic blood pressure less than 20% from the baseline SBP will be characterized as hypotension .Hypotension will be treated with IV fluid (Ringer lactate/normal saline),if required vasopressors (Ephedrine, Phenylephrine, Noradrenaline. Any adverse effects like nausea, vomiting ,headache, bradycardia will be treated accordingly.

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

  • Pregnant mothers with singleton fetus Elective and Emergency LSCS Patient Height- 150-180cm American Society of Anesthesiologist(ASA) grade I,II.

排除标准

  • parturient age less than 18 years and more than 40 years Body mass index more than 40 Parturient with placenta previa Eclampsia and pre-eclampsia cardiovascular or cerebrovascular disease Peripheral vascular disease.

结局指标

主要结局

To predict the incidence of post spinal hypotension from toe perfusion index of lower segment cesarean section patients.

时间窗: Baseline and post spinal anesthesia first 30 minutes

次要结局

  • To explore the correlation between toe Perfusion index and spinal hypotension and determine cut off value if any through ROC curves.(To assess the relationship between changes in the perfusion index in the right and left toe and incidence of post spinal hypotension)

研究者

发起方
Dr Aswini Gandhimathi R
申办方类型
Other [This thesis is sponsored by myself]
责任方
Principal Investigator
主要研究者

Dr Aswini Gandhimathi R

Chettinad hospital and research institute

研究点 (1)

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