Effect of Glycopyrrolate on Vasopressors Requirement for Non-elective Caesarean Section Under Spinal Anaesthesia
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 258
- 试验地点
- 1
- 主要终点
- Total vasopressors requirement intraoperatively
研究概览
简要总结
This is prospective randomised double blind study conducted in parturients planned for non-elective caesarean section under spinal anaesthesia. Glycopyrrolate group will receive 0.2 mg of Glycopyrrolate before start of phenylephrine infusion. Control group will receive 0.2 ml of Normal Saline before start of phenylephrine infusion. Total amount of vasopressors required i.e. ephedrine or phenylephrine will recorded in the form of phenylephrine equivalent during intraoperative period.
详细描述
Intravenous glycopyrrolate has been investigated for its effect on haemodynamic changes after spinal anesthesia for caesarean delivery. Results from previous studies are conflicting as glycopyrrolate has shown to reduce, increase or had no effect on incidence of maternal hypotension and/or vasopressor requirement after spinal anaesthesia. A recent meta-analysis found that prophylactic glycopyrrolate does not prevent the incidence of spinal-induced hypotension; however, it reduces the total vasopressor requirement during elective caesarean delivery under spinal anaesthesia. Therefore, the aim of this study is to find out whether the use of glycopyrrolate decreases the amount of vasopressors required to manage hypotension induced by spinal anaesthesia in non-elective CS.
Methodology:
After approval from Institutional Review committee of B.P. Koirala Institute of Health Sciences, the trial will be registered at clinical trial.gov. Parturient planned for non-elective caesarian of ASA PS grade II fulfilling the inclusion criteria will be informed about the study and written consent will be obtained either in labour room or in obstetric emergency ward. The eligible patients will be randomly assigned to Glycopyrrolate (GP group) or normal saline (NS group). The study will be conducted in accordance with the ethical principles of the 1964 Declaration of Helsinki. Before patient is shifted to the operating room (OR), ranitidine 50 mg and metoclopramide 10 mg will be administered intravenously via 18 G cannula. In the operating table, patients will be laid supine with a wedge placed in the right hip. Standard anaesthesia monitoring including 3-lead electrocardiography, heart rate (HR), noninvasive blood pressure (NIBP) and pulse oximetry (Sp02) will be done. A mean value of three measurements of systolic blood pressure (SBP) and HR will be recorded as baseline parameters. Patency of the vein will be maintained with the infusion of Ringer's lactate solution at a minimal rate.
Before the patient is placed in sitting position for SA,she will receive the study drug according to the randomization. After free flow of CSF is observed, 0.5 % hyperbaric bupivacaine (2.2 ml) with 10 µg fentanyl will be injected intrathecally over 30 s using a 25-gauge Quinke needle at the L3-4 or L4-L5 interspace. Patients will then be immediately placed in supine while maintaining 15 degree left lateral tilt. Co-loading of 1000 ml ringers lactate solution will be initiated at the start of spinal anaesthesia using a pressure bag and it will be completed within 10 min. Immediately after the spinal injection, phenylephrine infusion will be initiated at a rate of 25 µg/min and it will be titrated to maintain maternal SBP within 20 % of baseline.
The sensory level of anaesthesia will be checked using loss of cold sensation. Surgery will be allowed once the bilateral sensory block height at T6 is achieved. Oxygen at 40% will be administered via nasal cannula at 2-4 L/min until delivery.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Glycopyrrolate and normal saline will be administered as 1 ml clear fluid, and therefore, both patient and investigator will be blinded to the randomization and intervention.
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
- •Age between 18-40 years
- •All parturients at term (gestational weeks ≥ 37)
- •ASA (American society of Anaesthesiologist) PS (Physical status) grade II
排除标准
- •Age >40 year
- •ASA PS Grade >2
- •Maternal bradycardia (baseline HR< 60/min) or tachycardia (baseline HR> 100/min)
- •Pregnancy induced hypertension
- •Gestational hypertension
- •Known fetal abnormalities
- •Intrauterine growth retardation (IUGR)
- •Intrauterine fetal death (IUFD)
- •Contraindications to spinal anaesthesia
- •Contraindications to glycopyrrolate
- •Multiple pregnancy
- •BMI: > 30 kg/m2
- •Height: <150cm
研究组 & 干预措施
Experimental Group (GP)
Patients will receive 0.2 mg (1 ml) glycopyrrolate before phenylephrine infusion is initiated at 25mcg/min.
干预措施: Glycopyrrolate 0.2 MG/ML (Drug)
Placebo Group(NS)
patients will receive 1 ml normal saline (0.9%) before phenylephrine infusion is initiated at 25 mcg/min
干预措施: Normal saline (Drug)
结局指标
主要结局
Total vasopressors requirement intraoperatively
时间窗: immediately after spinal anaesthesia till the end of the surgery
Total vasopressors required to prevent hypotension during the period of surgery
次要结局
- The incidence of hypotension(after spinal anaesthesia till the end of the surgery)
- The incidence of shivering(after spinal anaesthesia till the end of the surgery)
- Maternal heart rate and(after spinal anaesthesia till the end of the surgery)
- Maternal systolic blood pressure(after spinal anaesthesia till the end of the surgery)
- The incidence of reactive hypertension(after spinal anaesthesia till the end of the surgery)
- The incidence of nausea(after spinal anaesthesia till the end of the surgery)
- The incidence of maternal bradycardia(after spinal anaesthesia till the end of the surgery)
- The incidence of vomiting(after spinal anaesthesia till the end of the surgery)
- The incidence of maternal tachycardia(after spinal anaesthesia till the end of the surgery)
- The incidence of dry mouth, intraoperative pruritus and dizziness(after spinal anaesthesia till the end of the surgery)
研究者
Rajesh Deshar
Principal Investigator
B.P. Koirala Institute of Health Sciences
