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临床试验/CTRI/2024/11/076209
CTRI/2024/11/076209尚未招募不适用

Comparison of goal directed hemodynamic therapy and conventional therapy on hemodynamic stability and perioperative clinical outcomes in patients undergoing sitting position neurosurgeries

G B Pant institute of postgraduate medical education and research1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年11月25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
30
试验地点
1
主要终点
Incidence of hypotension among the two groups evaluated by greater than 20% decrease in the mean arterial pressure from the baseline or a MAP less then 65mmHg

研究概览

简要总结

Anesthesia for sitting position neurosurgeries is associated with a serious risk of hemodynamic instability due to various reasons. This hypotension can  potentially  compromise the  cerebral perfusion which leads to poor patient outcome. Hence, maintenance of an adequate preload with optimal fluid administration, and  prompt treatment of the hypotension are important goals during sitting position neurosurgeries. Perioperative goal-directed hemodynamic therapy (GDHT)  can help to optimize the cardiovascular dynamics, organ perfusion pressure, and tissue oxygen delivery, based on predefined target values of hemodynamic variables that reflect end-organ blood flow in these patients. In contrast to conventional management which is largely guided by vital signs. Hence in this study we aim to compare the effect of GDHT with  conventional hemodynamic  management during these  neurosurgeries. We hypothesize that GDHT provides superior  hemodynamic stability and better  perioperative patient outcomes than conventional hemodynamic  management  in patients undergoing sitting position neurosurgeries.

In GDFT group patients, A protocolized approach will be followed, based on the following hemodynamic indices (by ICON non invasive cardio meter, Osypka Medical GmbH). 

Patients with an SVV > 13 or FTC< normal for their range [based on patient’s body mass index (BMI)] will be considered as fluid responders, and will be given upto three boluses of Normal saline (0.9%) boluses (5ml/kg over 5 mins), till SVV < 13/ FTC within normal range.  Hypotension (>20 % decrease in MAP from the baseline or a MAP < 65mmHg) will be treated as follows:

Ephedrine (three boluses- 6mg IV each, at 5min intervals):   If SVRI < Normal range (based on patients BMI); and CI and contractility indices within normal limits (based on patient’s  BMI) .

Dobutamine (2-20 mcg/kg/min) if CI and  contractility indices  < Normal range (based on  patient’s  BMI)

Norepinephrine (0.01-0.1μg/kg/min) for refractory hypotension.

Colloid [Hydroxyethyl starches boluses (200 ml)] will be  given if  CI  < normal range and  SVV > 13 / FTC < normal range (based on patients BMI)

In conventional group patients,

Normal saline (0.9%) will be administered as a maintenance fluid, to maintain CVP between 6 and 8 mmHg and a urine output of ≥0.5 ml/kg/h.  In case of hypotension, administration of colloids (6% hydroxyethyl starch 130/0.4), vasoactive agents (ephedrine, norepinephrine) and inotropes (dobutamine) will be as per the  discretion of the attending neuroanesthesiologist.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant 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

  • ASA physical status 1&2 patients scheduled for elective craniotomy in sitting position.

排除标准

  • Patients with Ischemic Heart Disease, Cardiac arrythmias/ Intracardiac shunts/ Severe valvular heart disease, Uncontrolled hypertension, Renal or hepatic disease, Diabetic patients with autonomic dysfunction, Pregnancy, Cervical canal stenosis.

结局指标

主要结局

Incidence of hypotension among the two groups evaluated by greater than 20% decrease in the mean arterial pressure from the baseline or a MAP less then 65mmHg

时间窗: Awake supine | 5mins post induction | Prior to preloading with colloid bolus | After colloid preload | Prior to change of position from supine to sitting | 5mins after achieving the sitting position | Every 30mins during surgery 5mins after repositioning the patient in supine position

次要结局

  • Intraoperative variables:(Hemodynamics)
  • Postoperative variables.(Length of hospital and ICU stay, Occurrence of postoperative complications, Neurological outcome)

研究者

发起方
G B Pant institute of postgraduate medical education and research
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

SAMPATH S

GB pant institute of postgraduate medical education and research

研究点 (1)

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