A randomized controlled trial to evaluate the neuroprotective effect of low-dose dexmedetomidine infusion in patients with isolated moderate to severe traumatic brain injury
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- Comparison of neuron-specific enolase γ (NSE γ) levels between the two study groups at the end of the study drug infusion.
研究概览
简要总结
Patients who fulfill the inclusion criteria will be taken in the OT, baseline sample for NSEγ and IL-6 will be initially taken, after which patient will be anaesthetised using standard anaesthesia protocol. The study drug(dexmedetomidine in study group, 0.9%normal saline in control group) will be initiated after induction at a dose of 0.3mcg/kg/hour, and continued post surgery in the ICU for 48hours. At the end of 48hour infusion in ICU, serum samples will be taken to assess NSE γ and IL-6. During the ICU stay, for 48hours - PI, ICP, eCPP will be assessed using TCD. Total number of days on mechanical ventilation, ICU days and hospital days will be assessed. Neurological status at discharge and at 3months after discharge to be assessed using mRS and GOSE.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients with isolated moderate to severe TBI (GCS 6-12 ) 2.Patients who are posted for Decompressive Craniectomy (DC) within 24 hours of TBI 3.Age between 18 and 65 years 4.ASA IE, IIE, IIIE.
排除标准
- •Patients with TBI who are conservatively managed. Those with EDH. Patients who are hemodynamically unstable preoperatively. Bradycardia.
- •heart rate less than 50beats/minute. Pregnant patients. Refusal to consent to study by patients kin. Those with renal failure, chronic liver disease, decompensated cardiac failure.
结局指标
主要结局
Comparison of neuron-specific enolase γ (NSE γ) levels between the two study groups at the end of the study drug infusion.
时间窗: Comparison of neuron-specific enolase γ (NSE γ) levels between the two study groups at the end of the study drug infusion (48hours)
次要结局
- To compare neurological outcome at 3 months by modified Rankin score (mRS) and Glasgow Outcome Scale- Extended (GOSE).(At 3months post hospital discharge, mRS and GOSE will be assessed.)
- Comparison of NSE γ levels in each group at the end of study drug infusion from the baseline value.(The sample (NSE γ) within each group before induction is compared with the sample taken after 48hours of infusion.)
- Comparison of Interleukin-6 (IL-6) levels between the two study groups at the end of the study drug infusion.(Comparison of Interleukin-6 (IL-6) levels between the two study groups at the end of the study drug infusion (48hours).)
- Comparison of IL-6 levels in each group at the end of study drug infusion from baseline value.(The sample(IL-6) within each group before induction is compared with the sample taken after 48hours of infusion.)
- Comparison of ICP derived from Pulsatility index (PI) and estimated Cerebral Perfusion Pressure (eCPP) using TCD 12 hourly during ICU stay in both groups.(ICP, PI, eCPP is measured every 12hours for 48hours of ICU stay.)
- Comparison of mechanical ventilation days, ICU days and hospital days in between the study groups.(Number of days on ventilator support, in ICU and total days of hospital stay will be assessed.)
- To compare neurological outcome at discharge by modified Rankin score (mRS) and GOSE.(At discharge from hospital, mRS and GOSE will be assessed.)
研究者
Pooja Santhosh
PGIMER, Chandigarh