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临床试验/CTRI/2026/02/103884
CTRI/2026/02/103884尚未招募不适用

Efficacy of preoperative oral midodrine as a prophylaxis against post induction hypotension in patients undergoing elective surgery under general anaesthesia

All India Institute of Medical Sciences, Jodhpur1 个研究点 分布在 1 个国家目标入组 414 人开始时间: 2026年2月27日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
414
试验地点
1
主要终点
To find out the incidence of post induction hypotension with General anaesthesia after preoperative medication with oral midodrine 5mg

研究概览

简要总结

Post induction hypotension is defined as arterial hypotension which occurred within 20mins of anaesthesia induction or from anaesthesia induction till the beginning of surgical incision. Worldwide the incidence of post GA induction hypotension increased upto 66%. Hypotension was defined as either MAP decrease of >40% and MAP <70mmHg or MAP<60mmHg. Propofol causes hypotension by decreasing peripheral vascular resistance. Intraoperative hypotension compromises vital organ perfusion which consequently increase the risk of kidney injury, brain ischemia, cardiac ischemia and postop ICU admission. During this post induction hypotension alpha adrenoceptor agonist, such as ephedrine, phenylephrine and norepinephrine are used. In this study oral midodrine will be used as prophylaxis against post induction hypotension . Midodrine hydrochloride is another alpha Adrenoceptor agonist which has the advantage of being an oral drug with minimal CNS side effect and good oral bioavailability. Midodrine is a prodrug, metabolized to Desglymidodrine[DGM] by the process called deglycination. This DGM act on alpha 1 receptors in the arteriolar and venous system cause constriction of vessels. In this study we aimed to evaluate the incidence of post GA induction hypotension after preoperative medication with oral midodrine 5mg [60 min before Sx].

The study aims to evaluate the incidence of post induction hypotension with general anaesthesia after preoperative oral midodrine. Patients with hypertension, DM, cardiac issues, kidney and liver problems, pheochromocytoma , thyrotoxicosis will be excluded. We would randomize the patient 90 mins before procedure to receive either 5mg midodrine[group A] or placebo[group B].60 mins before the procedure we would ask the patient to take midodrine or placebo. After induction MAP & HR would be monitored every 2 mins for 20 mins after induction.

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 60.00 Year(s)(—)
性别
All

入选标准

  • All ASA 1 patients who needs Surgical intervention under General Anaesthesia included in this study.

排除标准

  • Hypertensive patient, DM, Known cardiac patients, CKD, Liver disease patients, Urinary retention, Pheochromocytoma, Thyrotoxicosis, Patients whose are taking Digitalis and beta blockers, glaucoma.

结局指标

主要结局

To find out the incidence of post induction hypotension with General anaesthesia after preoperative medication with oral midodrine 5mg

时间窗: Patients vitals will be monitored from the time of induction to 20 minutes of induction .. | study will be continued over period of 1 year after the date of enrolment

次要结局

  • To find:(Intraoperative phenylephrine consumption.)

研究者

发起方
All India Institute of Medical Sciences, Jodhpur
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Prakash raj B

All India Institute of Medical Sciences, Jodhpur

研究点 (1)

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