A RANDOMIZED CONTROLLED TRIAL COMPARING MATERNAL AND NEONATAL EFFECTS OF BOLUS ADMINISTRATION OF EPHEDRINE AND PHENYLEPHRINE DURING SPINAL ANAESTHESIA FOR CAESAREAN SECTION
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- To compare the effect on neonatal cord blood PH after the administration of bolus doses of Ephedrine and Phenylephrine.
研究概览
简要总结
· After obtaining approval from the institutional ethical committee, informed consent will be taken from all patients in a language understood by them.
· All the patients will be kept nil by mouth for 6 hours prior to surgery, for solids, 2 hrs for liquids.
· On the day of surgery patients will be brought to the operation theatre and divided into two groups.
· Group allocation will be based on randomised sequence in which both assessor and patients will be blinded to group allocation by sealed envelope method.
· Before induction of anaesthesia, patient will be given ringer lactate solution (10ml/kg), 3 lead ECG attached, baseline blood pressure, mean arterial blood pressure, saturation, heart rate will be recorded in each patient. Standard monitoring of pulse rate, systolic, diastolic and mean blood pressure and saturation will be done intra-operatively.
· The patient will receive central neuraxial block by an expert anaesthesiologist. With the patient in the sitting position, 2.2 ml of 0.5% hyperbaric Inj.Bupivacaine with 30 mcg Inj.Buprenorphine will be injected intrathecally at L3-4 via a 25-gauge Quincke spinal needle. Patients will be then immediately turned supine and positioned with left uterine displacement.
· Sensory loss assessment will be done with wet gauze method.
· Additional boluses of similar dosage would be administered whenever the systolic pressure decreases more than 20% from baseline.
· Heart rate and blood pressure will be recorded immediately post- Spinal block and then at 1,3,5 min after it and later after every 5 min till delivery and then after every 15 min until the surgery ends.
· Arterial blood samples will obtained from a double-clamped segment of umbilical cord and analysed within 10 min. Neonatal cord blood pH and glucose levels will be noted.
· Any additional drugs if given, will be noted.
· Complications in the form of an allergic reaction, nausea, vomiting, dizziness, diminished consciousness will be noted.
· Requirement to conversion to general anaesthesia or need for supplementary rescue block or local infiltration by surgeon will be noted.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 46.00 Year(s)（—）
- 性别
- Female
入选标准
- •Patients undergoing elective lower segment caesarean section 2)American Society of Anaesthesiologists (ASA) Grade II.
排除标准
- •Patients not willing to participate in the study 2)Patients with pre-existing or pregnancy-induced hypertension, diabetes mellitus, known cardiovascular or cerebrovascular disease.
- •Patients with fetal abnormalities.
- •Patients indicated for LSCS i/v/o fetal distress.
- •Patients with any known hypersensitivity to any of the study drug.
- •Patients contraindicated to central neuraxial blocks.
结局指标
主要结局
To compare the effect on neonatal cord blood PH after the administration of bolus doses of Ephedrine and Phenylephrine.
时间窗: Intraoperative duration
次要结局
- 1)To compare maternal blood pressure and heart rate with administration of bolus doses of Ephedrine and Phenylephrine.(2)To compare effects on neonatal cord blood glucose levels after administration of bolus doses of Ephedrine and Phenylephrine.)
研究者
Dr. Varshali Keniya
Bharati Vidyapeeth Deemed to be University Medical College