Prediction of incidence of spinal hypotension using perfusion index from pulse oximetry of right and left toes in LSCS patients- A prospective Observational study
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
Dr Aswini Gandhimathi R
Chettinad hospital and research institute
