跳至主要内容
临床试验/CTRI/2022/10/046431
CTRI/2022/10/046431尚未招募4 期

Comparison of hemodynamic changes between phenylephrine and glycopyrrolate group after spinal anesthesia for caesarean delivery

krishna institute of medical sciences1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年10月13日最近更新:

试验速览

阶段
4 期
状态
尚未招募
入组人数
60
试验地点
1
主要终点
1.TO study and compare the severity of hypotension and bradycardia in parturients undergoing caesarean section under spinal anesthesia

研究概览

简要总结

AIM To study the efficacy of prophylactically intravenous administration of phenylephrine and glycopyrrolate to attenuate the hemodynamic responses of parturient during cesarean delivery under spinal anesthesia.

  OBJECTIVES To study and compare the severity of hypotension and bradycardia in parturient undergoing cesarean section under spinal anesthesia. And to study and compare the side effects i.e. nausea and vomiting in parturient undergoing cesarean section under spinal anesthesia

METHOD In my study  patients posted for elective cesarean section  under spinal anesthesia will be randomly allocated into two groups (30 each) , Phenylephrine group [P] and glycopyrrolate group [G]  after explaining the procedure to patient and informed consent .

PROCEDURE : Pre anesthetic checkup and preparation : In my study  patients posted for elective cesarean section  under spinal anesthesia will be randomly allocated into two groups (30 each ) , phenylephrine group [P] and glycopyrrolate group [G]  after explaining the procedure to patient and written informed consent . An 18-gauge intravenous cannula will be established in a forearm and preloaded with Hartmann solution of 10ml/kg .Premedication with Inj Ranitidine 0.5-1 mg/kg and Inj Metaclopramide 0.1-0.15 mg/kg will be  given in recovery to all patients. After shifting the patient in OR standard monitors i.e., heart rate (HR), systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial blood pressure (MAP) and oxygen saturation (sPO2) will be connected and baseline readings will be recorded . Spinal Anesthesia will be given to  patients in left lateral position with 25guage spinal needle at L3-4 or L4-5 vertebral interspace with 0.5% heavy Bupivacaine 2.2ml . Immediately after spinal anesthesia.

In P GROUP: The phenylephrine infusion will be started at a rate of 50 μg/min for 15 min and the hemodynamic values will be recorded at [1,3,5,7,9,11,13,15mins]. and at the same time 1cc of normal saline in 2cc syringe for double blinding. If the SBP is 30% above the baseline, the infusion will be stopped. If SBP ≤ 30%of baseline for 2 consecutive readings, despite the phenylephrine infusion, will be treated with a bolus of phenylephrine 50 μg.   If HR falls <60bpm Inj glycopyrrolate will be given IV (0.2mg)  .Total phenylephrine infusion dose given over 15mins will be recorded.

In G GROUP:  In group G , glycopyrrolate will be injected 1cc of 0.2 mg  intravenously in 2cc syringe after spinal anesthesia . If SBP is 30% below the baseline, phenylephrine bolus dose of 50mcg will be  given and recorded.If HR falls <60bpm  Inj Atropine will be given IV (0.6mg) in 1cc  .Hemodynamic changes will be recorderedover 15mins ( 1,3 ,5,7,9,11,13,15mins) .

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant and Investigator Blinded

入排标准

年龄范围
20.00 Year(s) 至 35.00 Year(s)(—)
性别
Female

入选标准

  • Parturients belonging to ASA 1 and 2 Age 20 to 35 years.

排除标准

  • Patients with cardiovascular disease Patients with cerebrovascular disease Pregnancy related hypertensive disease and diabetes mellitus Height less than 150cms or more than 180cms Weight less than 50kg or more than 100kgs Known fetal abnormalities Contraindications to glycopyrrolate Fever Twin pregnancies.

结局指标

主要结局

1.TO study and compare the severity of hypotension and bradycardia in parturients undergoing caesarean section under spinal anesthesia

时间窗: 1. maternal data such as age , BMI , baseline heart rate (HR) , systolic and diastolic blood pressure (SBP,DBP) , mean arterail pressure (MAP) | 2. HR,SBP,DBP measured for 15mins after induction of subarachnoid block . | 3.incidence if hemodynamic adverse effects.

2.And to study and compare the side effects nausea and vomiting

时间窗: 1. maternal data such as age , BMI , baseline heart rate (HR) , systolic and diastolic blood pressure (SBP,DBP) , mean arterail pressure (MAP) | 2. HR,SBP,DBP measured for 15mins after induction of subarachnoid block . | 3.incidence if hemodynamic adverse effects.

次要结局

未报告次要终点

研究者

申办方类型
Research institution and hospital

研究点 (1)

Loading locations...

相似试验