Role of Dexmedetomidine on Haemodynamics and Anaesthetic Requirement In Patients Undergoing Elective Infratentorial Tumour Surgery: A Prospective Randomized Double Blind Placebo Controlled Study
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- To observe the effect of dexmedetomidine on Heart rate, Systolic blood pressure, Diastolic blood pressure, Mean arterial pressure during intraoperative period.
研究概览
简要总结
Patients with intracranial pathology are in compromised state of cerebral dynamics, intracranial pressure and cerebral perfusion. Cerebral autoregulation keeps cerebral blood flow constant in face of changing perfusion pressure or Mean arterial pressure (MAP) by altering cerebrovascular resistance. Sharp fluctuation in cerebral blood flow, cerebral blood volume and intracranial pressure is a risk factor for neurological deterioration. Dexmedetomidine is highly selective alpha 2 agonist with hypnotic, sedative, anxiolytic, sympatholytic and analgesic properties which help in maintaining hemodynamic stability throughout intraoperative period. In addition to this it also reduces the requirement of volatile anaesthetic agent like isoflurane and opioid like fentanyl during intraoperative period. The purpose of this study is to investigate whether dexmedetomidine administered during surgery can maintain hemodynamic stability in patient those who are undergoing elective infratentorial tumour surgery
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator 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 grade- 1&2 surgery duration 4-5 hr elective surgeries infratentorial tumor surgery GCS not less than 14-15.
排除标准
- •hypertensive on other alpha 2 agonist severe intracranial hypertension preoperative heart rate less than 45 2&3 degree AV block patient on anti arryhthmic drug and beta blocker anticipated difficult intubation hypersenstivity to test drug pregnancy morbid obesity patient with chronic lung, renal and hepatic disease post head injury.
结局指标
主要结局
To observe the effect of dexmedetomidine on Heart rate, Systolic blood pressure, Diastolic blood pressure, Mean arterial pressure during intraoperative period.
时间窗: baseline before induction | every 5 min after induction | end of surgery
次要结局
- intraoperative fentanyl requirement(Intraoperative period from induction of anesthesia till end of surgery)
- Minimum alveolar concentration [MAC] of isoflurane to maintain optimum hemodynamics required for the surgery(intraoperative period from induction of anesthesia till end of surgery)
研究者
Twinkle
Rajendra Institute of Medical Science