A Randomized Controlled Study To Evaluate The Anxiolytic Effect Of Midazolam In Patients Of Cesarean Section At S M S Medical College ,Jaipur
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- To Asses And Compare Anxiolytic Effect Of With Or Without Midazolam In Patients Of Cesarean Section
研究概览
简要总结
This study is a randomized,double blind,interventional controlled study.The aim of study : To deyermine anxiolytic efficacy of midazolam administered pre operatively,in patients of cesarean section and to evaluate whether its administration impacts neonatal vitality,maternal consciousness and recall of moment the baby was born.
patient fulfilling inclusion criteria will be selected
patient will be received in the OT,patients will be identified PAC,informed written consent and fasting status will be checked
following data will be recorded - age ,weight,height,parity,caesarean deliveries , gestational age
pre operative vitals will be recorded (HR,SBP.DBP,SPO2)
18G iv line will be secured in upper limb and ringer lactate solution will be started
perform visual facial anxiety scale score for level of anxiety assessment
randomisation and allocation
GROUP A (n=80) GROUP B (n=80)
MIDAZOLAM GROUP CONTROL GROUP
will receive single intravenous bolus will receive intravenous an identical volume of 0.9%saline as placebo solution
dose of midazolam of 0.0125mg/kg
administration of solution occur in the interval between randiomisation and positioning the patient for spinal anaesthesia
spinal anaesthesia performed with patient in a sitting position with a 25G quincke type needle by injection 0.5% hyperbaric bupivacaine 2ml
visual facial anxiety scale score assessment at 5 min, 15min,15min
5 minutes after level of sedation by ramsay scale
apgar score at 1st and 5 th minute will be noted
intraoperative vital parameters will be recorded at 5 min interval
at the last, the mother will be asked about recall of moments of birth(at time of presentation and 90 minutes after time of birth)
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- Female
入选标准
- •1.Patients Undergoing Cesarean Section 2.Patients Giving Informed Written Consent
- •Patients Belonging To American Society Of Anaesthesiologist Physical Status 2.
排除标准
- •Pregnant Woman With Under Developed Fetus Or With Malformation
- •Pregnant Woman With Acute Fetal Distress
- •Pregnant Woman With Multiple Pregnancy
- •Pregnant Woman With Cardiac Disorder Moderate To Lung Disorder Moderate To Severe Psychopathologies Pregnancy Induced Hypertension coagulopathies Allegic To Drugs Local Infection At Site Spinal Deformities
- •Patients Should Not Be A Part Of Any Other Study.
结局指标
主要结局
To Asses And Compare Anxiolytic Effect Of With Or Without Midazolam In Patients Of Cesarean Section
时间窗: 90 Minutes
次要结局
- 1. To Asses And Compare APGAR Ramsay Sedation Scale Recall Of Moments Of Birth In Study Groups(2. To Determine The Change In Hemodynamic Parameter HR SBP DBP SPO2)
研究者
Dr Trishala Jain
Sawai Man Singh Medical College Jaipur