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临床试验/CTRI/2024/12/077678
CTRI/2024/12/077678尚未招募Phase 3 4

COMBINATION OF 10 PERCENT MANNITOL WITH 10 PERCENT GLYCERINE VERSUS 20 PERCENT MANNITOL FOR INTRAOPERATIVE BRAIN RELAXATION IN PATIENTS WITH ACUTE ANEURYSMAL SUBARACHNOID HAEMORRHAGE UNDERGOING CRANIOTOMY AND CLIPPING OF ANEURYSM

Postgraduate Institute of Medical Education and Reseach1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2024年12月15日最近更新:

试验速览

阶段
Phase 3 4
状态
尚未招募
发起方
入组人数
200
试验地点
1
主要终点
To compare the intraoperative brain relaxation scores

研究概览

简要总结

Brain relaxation is an important aspect of anesthetic care during intracranial surgery. Optimal brain relaxation improves the surgeon’s operating conditions and is likely to minimize the severity of retraction injury.1 Brain relaxation should be used to describe a clinical entity that has anesthetic, surgical, physiological, and outcome implications 2 . Moreover, they are often recognized as contributors to secondary brain injury, devastating neurological outcomes, and even brain death,

The combination of mannitol and glycerol comprises a combination of two sugars with better osmotic diuretic properties. Either glycerol or mannitol can be administered individually; however, the addition of glycerol to mannitol allows the lower concentration of the agents, hereby, minimizes the side effects of both agents. There is insufficient data to compare the effect of 20% mannitol plus 10% glycerol combination and 20% mannitol with a similar osmotic load in patients with aneurysmal subarachnoid haemorrhage (aSAH). These two drugs, combination of mannitol plus glycerol and mannitol are nearly equimolar. The osmolarity of combination of mannitol plus glycerol is 1049 and mannitol is 1098.Hence the study is planned to compare the brain relaxation score with the combination of mannitol with glycerine versus mannitol alone in patients with aSAH undergoing craniotomy and clipping.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant, Investigator and Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • The patients with acute aSAH are posted for craniotomy and clipping of aneurysm in the age group between 18-65 years of either age will be enrolled in the study.

排除标准

  • Patients who received any decongestant in the previous 6 hours Major organ dysfunction including liver, kidney, and heart.
  • Patients having Lumbar drain or external ventricular drainage before surgery.

结局指标

主要结局

To compare the intraoperative brain relaxation scores

时间窗: at dura opening

次要结局

  • To compare between the groups: Intraoperative haemodynamic variables including Heart rate, Systolic/Diastolic and(Mean blood pressure.)
  • To compare between the groups:urine output(Intraoperatively, Postoperatively till 48 hrs)
  • To compare between the groups: Change in serum osmolarity & blood sugar(at baseline & at one hour after infusion)
  • To compare between the groups: Number of patients requiring rescue drugs for brain bulge(at dura opening)
  • To assess change from baseline: Electrolytes (Sodium, Potassium, Calcium(Baseline, 1 hour after infusion, at the end)
  • To assess change from baseline serum Osmolality(at baseline & one hour after the study infusion.)
  • To compare the incidence of adverse outcomes(AKI (Using AKIN Criteria))

研究者

发起方
Postgraduate Institute of Medical Education and Reseach
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

MITLESH KUMAR

Postgraduate Institute Of Medical Education And Research

研究点 (1)

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