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临床试验/NCT05892913
NCT05892913已完成4 期

Treatment of Sympathetic Blockade During Spinal Anesthesia in Cesarian Section Patients With Low-dose, Slow-administered Preemptive Atropine

Abant Izzet Baysal University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年7月19日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
60
试验地点
1
主要终点
Heart rate

研究概览

简要总结

The most common side effect in cesarean section surgeries performed under spinal anesthesia is hypotension, which is seen in over 80% and can cause significant morbidity for the mother and fetus. This side effect results from the sympathetic blocking effect, which also causes bradycardia.

A combined approach is supported in the prevention and treatment of hypotension, which recommends adequate fluid support, low-dose spinal anesthesia, and appropriate vasopressor (such as ephedrine, and phenylephrine) and, if bradycardia develops, the use of atropine as a parasympatholytic agent.

In this study, the investigators planned to investigate the possible benefits of preemptive administration of atropine, the dose of which is calculated in proportion to the patient's weight, as soon as a 10% decrease in heart rate is detected, in order to balance the sympathetic blockade due to spinal anesthesia in cesarean section operations.

详细描述

Our study was approved by the Ethics Committee of Bolu Abant Izzet Baysal University, ASA Ι-ΙΙ, ages 18-40, weight 55-105 kg, height 150-175 cm, with an indication for elective cesarean section, and informed consent will be obtained for the study. Sixty pregnant patients at term scheduled for cesarean delivery under spinal anesthesia will be included.

Those who do not require drug administration with fluid therapy, whose hemodynamic changes are within acceptable range, have systemic disease (Diabetes, COPD, Hypertension), have BMI>34, have a diagnosis of preeclampsia/eclampsia or multiple pregnancy, have pathology in the fetus, have hematological problems such as Rh incompatibility, patients with hypersensitivity to local anesthetics and who are in a position to be a contraindication to regional anesthesia applications will be excluded from the study.

Dexamethasone 4 mg IV for antiemetic purposes was planned for all patients as premedication before the intervention. It was planned to record systolic blood pressure (SBP), diastolic blood pressure (DBP), mean blood pressure (MBP), heart rate (HR), oxygen saturation (SpO2) and respiratory rates by noninvasive method by monitoring the patients with the Mindrey device. In all cases, 2 vascular accesses will be opened with an 18 G (Gauge) intravenous cannula. Intravenous pre-loading was planned for all cases, with 300 cc 0.9% NaCl removed in 15 minutes preoperatively.

Patients will be divided into 2 groups by online randomization method.(Studyrandomizer.com) Fixed dose local anesthetic will be preferred in both groups. After all cases are placed on the operating table and given an anatomical position suitable for spinal anesthesia in a sitting position, skin cleaning will be performed under sterile conditions in the area where the intervention will be performed. Appropriate intervertebral space (L3-L4) will be determined and when the free flow of CSF will be seen after entering the subarachnoid space with a sterile 25-27 G pencil point spinal needle (Egemen/ISTANBUL/TURKEY), 15 mg (2.5 mL) pure (isobaric 0.5% bupivacaine( Marcaine 0.5%/Astra Zeneca/England) ) will be applied. After the application, the patient will placed in the supine position and it will be planned to administer 3 L/min O2 by nasal cannula. After spinal anesthesia, it will planned to start 5 ml/kg/hour 0.9% NaCl solution (Neofleks/Ankara/Turkey) as a maintenance fluid for the patients in both groups during the operation.

In both groups, SBP, DBP, MBP, HR and SpO2 measurements will be recorded at 1, 4, 7, 9, 12, 15, 30, 45, 60, 120 and 240 minutes after the patient is placed left lateral tilt position on the table. After the spinal injection, sensory and motor block levels will be recorded every 3 minutes in the first 15 minutes, and then at the 20th, 25th, 30th, 45th and 60th minutes. It has planned to evaluate the level of sensory block as a dermatome level with the hot-cold test, and motor block by using the Bromage Scale.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • ASA Ι-ΙΙ Ages 18-40 Weight 55-105 kg Height 150-175 cm

排除标准

  • Who does not require drug administration with fluid therapy Whose hemodynamic changes are within an acceptable range Diabetes COPD Hypertension BMI>34 Preeclampsia/eclampsia Multiple pregnancies Pathology in the fetus Hematological problems such as Rh incompatibility Hypersensitivity to local anesthetics Contraindications to regional anesthesia

研究组 & 干预措施

Efedrine Group

Active Comparator

For sympathetic blockade (SBP<90) if developed in patients in the ephedrine group, a bolus dose of 5 mg/mL ephedrine would be used and repeated if necessary. In case of development of bradycardia (<65/min) in this group, Atropine 0.5 mg/mL would be planned to be administered and repeated if necessary.

干预措施: Ephedrine (Drug)

Preemptive Atropine Group

Experimental

In the atropine group, it will planned to administer 0.4 mg/4mL diluted atropine in 20 seconds(10mcg/kg), as a slow bolus as bradycardia would expected (10% reduction in peak heart rate after spinal anesthesia). In this group if SBP<90 despite slow dose atropine administration; it will be planed to give efedrine as bolus of 5 mg/mL. And for bradicardia (HR<65/min) it will be planed to give Atropine 0.5 mg/mL.

干预措施: Slow dose preemptive Atropine (Drug)

结局指标

主要结局

Heart rate

时间窗: 15. minute after spinal block

Heart rate

Mean Blood Pressure

时间窗: 15. minute after spinal block

Mean Blood Pressure

Systolic Blood pressure

时间窗: 15. minute after spinal block

Systolic Blood pressure

Efedrine Consumption

时间窗: 15. minute after spinal block

Efedrine Consumption in the first 15 minutes after the spinal block

Atropine Consumption

时间窗: 15. minute after spinal block

Atropine Consumption in the first 15 minutes after the spinal block

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Akcan AKKAYA Prof. MD.

Professor Dr.

Abant Izzet Baysal University

研究点 (1)

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