Effect of Dexmedetomidine on cerebral blood flow auto-regulation in patients with intracranial tumours.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- effect of dexmedetomidine on cerebral vascular autoregulation
研究概览
简要总结
Informed consent will be taken from Patients satisfying inclusion criteria. Consenting patients will be included in the study protocol.
Patient will be shifted in to operating room. Monitors will be attached and baseline HR, NIBP, SpO2, EtCO2 will be recorded.
Ultrasound scan ( grey scale & Doppler ) of bilateral carotid arteries to rule out plaque, stenosis or other flow limiting lesions.
Under Lignocaine (2%) skin infiltration I.V access and arterial access will be obtained.
baseline analysis :
· TCCDI analysis of Right and left Middle cerebral artery flow velocity
· Baseline flow velocity for 5 seconds
· Flow velocity Compression of Rt. Side carotid artery ( 3 sec )
· Flow velocity After release of compression for 5 seconds
·
infusion of Inj. Dexmedetomidine 1 mcg/Kg/ 10 min by infusion pump.
Continuous Vital parameters monitoring 10 min ( HR/IBP/SpO2/EtCO2 )
Post dexmedetomidine analysis :
Continuous Vital parameters monitoring ( HR/IBP/SpO2/EtCO2 )
· TCCDI analysis of Right and left MCA flow velocity
· Baseline flow velocity for 5 seconds
· Flow velocity Compression of Rt. Side carotid artery ( 3 sec )
· Flow velocity After release of compression for 5 seconds
·
After induction routine anaesthesia protocol will be employed.
Data collection: manual entry into the study proforma.
Observations:
Baseline heart rate, Invasive blood pressure (sys/ dias/ mean), oxygen saturation before starting the anesthesia induction .
Baseline recording of MCA flow velocity, pulsatility index & resistance index on both hemispheres using Transcranial colour Doppler imaging.
Auto regulation assed by Transient hyperaemic response
The hemodynamic variables (HR ,SBP,DBP and MAP) ,oxygen saturation, End tidal carbon dioxide (EtCO2) & respiratory rate during induction with Dexmedetomidine
Heart rate, Invasive blood pressure (sys/ dias/ mean), oxygen saturation after induction with Dexmedetomidine.
Recording of MCA flow velocity, pulsatility index & resistance index on both hemispheres using Transcranial colour Doppler imaging after induction with Dexmedetomidine.
Auto regulation - Transient hyperaemic response after induction
Any hemodynamic and respiratory adverse events such as hypotension, hypertension, Bradycardia, oxygen desaturation and other events will be recorded.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- All
入选标准
- •two groups (15 patients in each group) Group I.
- •patients with unilateral Glioma, Glascow coma scale 15, American society of anesthesiology Grading 1 and
- •patients having no intracranial pathology ( patients posted for lumbar and thoracic spinal cord surgeries (laminectomy, discectomy), American society of anesthesiology Grading 1 and 2.
排除标准
- •Patient refusal, American society of Anesthesiology (ASA) class 3 and above, Age less than 18 years and more than 35 years, Preoperative Glasgow coma scale (GCS) <15, Intracranial vascular abnormalities, Documented cases of Carotid stenosis, atherosclerosis, Infra tentorial / posterior fossa tumours, Emergency surgery, Preoperative heart rate <50 bpm, Systemic hypertension stage III & above, Heart block, Known allergy to Dexmedetomidine, Patient on beta blockers, Coronary artery disease, Left ventricular dysfunction,Pregnant or Nursing woman.
- •Antihypertensive medication with alpha-methyldopa, clonidine or other a2-adrenergic agonist, Vascular pathology ( Plaque, calcification, narrowing, stenosis, abnormal flow pattern ) identified during pre-induction sonography, Difficulty in localizing intracranial vasculature by TCCDI, Abnormal bone window, Participation in another drug study during the preceding 1 month period.
结局指标
主要结局
effect of dexmedetomidine on cerebral vascular autoregulation
时间窗: immediately after completion of Dexmedetomidine infusion
次要结局
- cerebral hemodynamics, and cerebral vascular resistance(immediately after infusion of Dexmedetomidine)