Evaluation of Neuroprotective Effect of Dexmedetomidine in Traumatic Brain Injury
试验速览
- 阶段
- 1 期
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- The change in CBF during sedation.
研究概览
简要总结
patient wih mild to moderate traumatic brain injury in ICU will be randomisly distributed into two groups Group I (control group): Patients of this group receive placebo infusion for 72 hours. Group II (DEX group): Patients of this group receive 0.5 ug/kg/hr dexmedetomidine continuous infusion for 72 hour Patient demographics, including age, sex, weight, primary diagnosis, Acute Physiology and Chronic Health Evaluation (APACHE) II score and postresuscitation Glasgow Coma Scale (GCS) score will be collected. CBF will be measured at pre-sedation and after cessation of sedation (dexmedetomidine administration). The CMRe and CMRe/CBF will also be calculated. Measurements of blood gas analysis and haemodynamic parameters [systolic blood pressure (SBP), diastolic blood pressure (DBP), MAP and heart rate (HR)] will be collected at pre-sedation and after cessation of sedation (dexmedetomidine administration).
详细描述
Assessment will be done for the patients by taking careful medical history for any medical disorder, therapeutic anticoagulant, allergy to chemical compounds or addiction problems, and performing trauma survey check up ( chest x-ray, abdomen US, CT brain for documentation of injury) with general and physical examination for CNS (assessement of GCS) , chest, heart, abdomen and peripheral limbs for any abnormality . Then, routine and relative investigations will be carried out such as complete blood picture, renal and liver function tests, coagulation tests and random blood sugar.
all patients will be monitored with five- lead ECG, non-invasive blood pressure, pulse oximetry and end tidal CO2. Then a 20 gauge IV cannula will be inserted into a peripheral upper extremity vein for drug administration and ( DEX group) patients received 0.5 ug /kg/hr dexmedetomidine continuous infusion for 72 hour. Ephedrine will be administrated to maintain the MAP at the pre-sedation level if BP decrease 20 % from baseline BP and atropine if pulse decrease below 50 b/m . No extra sedatives, other vasoactive drugs or volume resuscitation will be used during sedation. Patient demographics, including age, sex, weight, primary diagnosis, Acute Physiology and Chronic Health Evaluation (APACHE) II score and postresuscitation Glasgow Coma Scale (GCS) score will be collected. CBF will be measured at pre-sedation and after cessation of sedation (dexmedetomidine administration). The CMRe and CMRe/CBF will also be calculated. Measurements of blood gas analysis and haemodynamic parameters [systolic blood pressure (SBP), diastolic blood pressure (DBP), MAP and heart rate (HR)] will be collected at pre-sedation and after cessation of sedation (dexmedetomidine administration).
CBF measurement :
CBF will be evaluated in the extra-cranial internal carotid artery (ICA) and vertebral artery (VA) using a spectral Doppler ultrasound technique . Briefly, the procedure will be performed with the patient in the supine position with a 7.5-MHz linear array transducer of a colour coded ultrasound system . The patients' head will slightly be elevated and turned to the contralateral side at a 25 - 40 angle for ICA measurements and at a 10 angle for VA measurements. ICA will be assessed at the segment located 1.5 cm distal to the carotid bifurcation and VA will be measured between the transverse processes of the C4 and C5 vertebrae.
Blood flow velocities will be obtained by keeping the Doppler insonation angle at a standard 60. Time averaged flow velocity (TAV) will be determined as the integral of the mean flow velocities of all moving particles passing the sample volume over 3-5 complete cardiac cycles. The TAV, peak systolic velocity, end-diastolic velocity and inner vessel diameter (d) will be measured during the bilateral ICA and VA CBF measurements. The intravascular flow volume (FV) of each artery will be calculated by the formula: FV= TAV x (d/2) x ℼ CBF will be calculated as the sum of bilateral ICA and VA flow volumes. All ultrasound examinations will be performed in triplicate by the same radiologist using the same Doppler ultrasonography device.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
no participant ,investigator or outcome assessor in ICU know in which group patient is allocated
入排标准
- 年龄范围
- 18 Years 至 60 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •1 - Patient relative refusal. 2-Severe traumatic brain injury GCS < 8 3-prescence of other organ injury. 4-MAP lower than 80 mmHg 5- hepatic or kidney function dysfunction 6-received any vasoactive agents or sedatives or recieve drugs that affect CBF during the experiment 7- Pregnant.
研究组 & 干预措施
Group I (control group):
Patients of this group receive placebo infusion for 72 hours.
干预措施: placebo salin infusion (Drug)
Group II (DEX group):
Patients of this group receive 0.5 ug/kg/hr dexmedetomidine continuous infusion for 72 hour
干预措施: Dexmedetomidine (Drug)
结局指标
主要结局
The change in CBF during sedation.
时间窗: 6 months
cerebral blood flow will be measured whether changed by dexmedetomine infusion or not
次要结局
未报告次要终点
研究者
Wafaa Madhy Atia Abdelwahed
lecturer
Tanta University
