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临床试验/CTRI/2024/11/076508
CTRI/2024/11/076508尚未招募2/3 期

A Comparative Study Of Effects Of Mephentermine versus Effects Of Phenylepherine In Patient Undergoing Lscs Under Spinal Anesthesia

Dr Saksham Garg1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年12月2日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
100
试验地点
1
主要终点
Blood Pressure

研究概览

简要总结

The study "A study to compare the vasopressor effects of Mephentermine vs Phenylephrine in patients undergoing LSCS under Spinal Anesthesia" will be conducted in the Department of Anesthesia at Varun Arjun Medical College and Rohilkhand Hospital, Banthra, Shahjahanpur, Uttar Pradesh 242307.

A. The study will be conducted on consenting patients scheduled for elective Lower Segment Caesarean Section (LSCS) under spinal anesthesia, presenting to the Anesthesia department at Varun Arjun Medical College and Rohilkhand Hospital from April 2024 to April 2025 based on inclusion and exclusion criteria.

B. All patients selected for the study will undergo detailed history taking and provide written informed consent.

C. Pre-Anesthetic assessment.

D. Laboratory assessment.

E.  Patients will be randomly allocated into two groups:

  • Group A: Patients receiving Mephentermine (bolus dose 6 mg) as the primary vasopressor during spinal anesthesia.
  • Group B: Patients receiving Phenylephrine (bolus dose 100 mcg) as the primary vasopressor during spinal anesthesia.

F. Maternal Monitoring: SBP, DBP, MAP, and HR recorded at specified intervals after subarachnoid block until delivery of the baby.

G. Adverse Events: Any adverse events, such as nausea, vomiting, or other side effects, will be recorded.

研究设计

研究类型
Interventional
分配方式
Other
盲法
None

入排标准

年龄范围
20.00 Year(s) 至 40.00 Year(s)(—)
性别
Female

入选标准

  • ASA grade I and II Patients who gave written informed consent.

排除标准

  • ASA grade III or greater Base line heart rate less than 60 bpm Base line blood pressure less than 100 by 60 mmhg Multiple Gestation Participants with a history of significant cardiovascular diseases, such as coronary artery disease or heart failure, will be excluded Women with pre-existing renal dysfunction or renal diseases will be excluded due to potential complications related to vasopressor use Participants with pre-existing diabetes mellitus will be excluded, as diabetes can influence vascular responsiveness Women with known allergies or sensitivities to Mephentermine or Phenylephrine will be excluded.

结局指标

主要结局

Blood Pressure

时间窗: 1, 2, 3, and 5 mins after subarachnoid block for the first 5 mins minutes and every 5 min thereafter till the delivery of the baby

次要结局

  • Heart Rate(1, 2, 3, and 5 mins after subarachnoid block for the first 5 mins minutes and every 5 min thereafter till the delivery of the baby)

研究者

发起方
Dr Saksham Garg
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr SAKSHAM GARG

Varun Arjun Medical College and Rohilkhand Hospital

研究点 (1)

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