COMPARISON BETWEEN EFFICACY OF NOREPINEPHRINE AND PHENYLEPHRINE BOLUSES FOR PREVENTION OF SPINAL ANAESTHESIA INDUCED HYPOTENSION IN OBSTETRICAL PATIENTS UNDERGOING EMERGENCY CESAREAN SECTION- A Double Blind Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 124
- 试验地点
- 1
- 主要终点
- Incidence of spinal anesthesia induced Hypotension
研究概览
简要总结
The goal of this clinical trial is to learn if norepinephrine is more effective than phenylephrine for prevention of spinal anesthesia induced hypotension. The main questions it aims to answer are:
Does norepinephrine lower the incidence of spinal anesthesia induced hypotension in emergency obstetrical patients? We will compare effectiveness of norepinephrine and phenylephrine for the prevention of spinal anesthesia induced hypotension.
Participants will:
Be administered prophylactic boluses of both drugs right after spinal anesthesia induction and maternal hemodynamic parameters and neonatal APGAR scores will be recorded
详细描述
Spinal anesthesia is a common mode of anesthesia in cesarean delivery. Spinal anesthesia induced hypotension is one of the most common complication that can affect both mother and fetus. For the management of spinal anesthesia induced hypotension, preloading with crystalloids and colloids, use on ionotropic agents and vasopressors have already been in practice.
Objective of this study is to compare efficacy of prophylactic use of norepinephrine and phenylephrine bolus dosage for spinal anesthesia induced hypotension.
This study is being conducted at the department of anesthesiology ,K.M Pfau civil hospital, Dow university of health sciences, Karachi , Pakistan. Data is being collected after taking approval from Institutional review board and written informed consent from the participants.
Participants are being enrolled by primary investigator. All participants are undergoing simple randomization by lottery method.
After enrollment of participants, demographic data, hemodynamic parameters and other relevant details are being recorded till delivery of the neonate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
盲法说明
both participants and investigator is unaware about the drug given. Data is being collected by the anesthesiologist who is not involved in this study.
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •American society of anesthesiologists II and III patients
- •Age 18-40years
- •Gestational age 32 weeks and above
排除标准
- •Patients with hypertensive disorders of pregnancy having baseline systolic blood pressure greater than 160 mmHg and diastolic blood pressure greater than 99 mmHg.
- •Baseline mean arterial pressure less than 70 mmHg.
- •Antepartum hemorrhage/intraoperative blood loss greater than 1000ml
- •history indicative of cardiovascular or neurological disease.
- •known fetal abnormality.
- •Patients taking serotonin reuptake inhibitor, Tricyclic antidepressants,monoamine oxidase inhibitors.
- •Maternal situations requiring immediate administration of general anesthesia
研究组 & 干预措施
Group P
Prophylactic bolus of phenylephrine will be administered right after spinal anesthesia induction
干预措施: Phenylephrine bolus (Drug)
Group N
Prophylactic bolus of norepinephrine will be administered right after spinal anesthesia.
干预措施: Norepinephrine Bolus (Drug)
结局指标
主要结局
Incidence of spinal anesthesia induced Hypotension
时间窗: From induction of spinal anesthesia till delivery of neonate
Prophylactic norepinephrine and phenylephrine boluses will be administered to both groups right after spinal anesthesia induction.greater than 80% drop of the Systolic blood pressure will be defined as hypotension.
次要结局
未报告次要终点
研究者
Rabia Kamal
FCPS Anesthesiology resident
Dow University of Health Sciences