Pregabalin Effects on Hypotensive Anesthesia During Spine Surgery.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 106
- 试验地点
- 2
- 主要终点
- Nitroglycerin consumption
研究概览
简要总结
Elective lumbar spine surgical procedures are commonly performed under controlled hypotension during general anesthesia. That is beneficial to limit the intraoperative blood loss and transfusions and improves surgical field. Deliberate hypotension could be achieved via various medications but mostly associated with significant side effects. Pregabalin effectively augmented hypotensive anesthesia. The hypothesis is that Pregabalin 150 mg single preoperative dose may augment intraoperative deliberate hypotension that will be reflected on blood loss and nitroglycerin consumption.
详细描述
An arterial line will be established then general anesthesia will be conducted. After adequate preoxygenation, anesthesia induction by IV fentanyl 1.5µg/kg, propofol 2 mg/kg, and atracurium 0.5 mg/kg then appropriated size tracheal tube. The ventilator settings will be adjusted to maintain the end-tidal carbon dioxide tension (ETco2) at 30-35 mm Hg. Anesthesia will be maintained by isoflurane concentration 1.2%, with 40% oxygen in air then IV infusion of fentanyl 0.05 mcg/kg/min was started while atracurium 0.1 mg/kg incremental dose as required. Then patients will be turned into the prone position above pad support permitting free hanging of the abdomen. Intraoperatively, the target mean arterial arterial blood pressure (MBP) is 55-65 mm Hg. After surgical incision, if MBP exceeds 65 mm Hg (defined as hypertension) it will be managed by: increasing isoflurane MAC up to 2%, if no response after 5 min, Nitroglycerin infusion initiated at 0.5 mcg/kg/min to 40 mcg/kg/min. Hypotension (MBP <55 mm Hg) will be treated by stopping nitroglycerin, proper compensation of losses, reducing Isoflurane MAC. If persisted; vasoactive drugs will be used. Bradycardia (HR <50 beat/min.), treated with 0.01 mg/kg atropine IV increments.
The nitroglycerin infusion will be stopped after the finial surgical hemostasis. Fentanyl infusion will be stopped before ligament sutures. Isoflurane will be closed after the last surgical suture. After dressing, patient will be turned to the supine position and morphine 0.025 mg/kg IV will be administered then 0.04 mg/kg neostigmine and 0.015 mg/kg atropine for reversal. Extubation will be done after establishment of acceptable spontaneous respiration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiologists (ASA) score I-II
- •admitted to undergo lumbar discectomy or spinal fixation surgery under general anesthesia
排除标准
- •Patients on anti-hypertensive treatment, diuretics, corticosteroids, pregabalin, gabapentin, anticonvulsants, antipsychotics,
- •alcohol addiction or drug abuse
- •patients with history of allergy to any drug used in the study .
- •pregnant or nursing women
- •patients with peripheral neuropathy, endocrinal diseases, bleeding abnormality,
- •cardiac, hepatic or renal impairment
研究组 & 干预措施
Pregabalin group
(n=53):
干预措施: Pregabalin (Drug)
placebo group
(n=53):
干预措施: placebo (Drug)
结局指标
主要结局
Nitroglycerin consumption
时间窗: Intraoperative
the total nitroglycerin consumption in milligram to maintain the target mean arterial pressure (MAP) 55- 65 mmHg.
次要结局
- Estimated blood loss(intraoperative)
- end-tidal isoflurane concentration(at 30, 60, 90, 120, 150 , 180, 210 minutes after intubation.)
- The time to the first request of analgesia.(24 hours postoperative)
- Peak airway pressures(10 minutes after settled prone position)
- invasive mean arterial blood pressure (MAP)(Basal, during intubation, then at 1, 5, 30, 60, 90, 120, 150, 180, 210 minutes post extubation, then postoperatively at 1 and 2 hours.)
- Frequency of adverse effects(during the first 24 hours postoperatively)
- heart rate (HR)(Basal, during intubation, then at 1, 5, 30, 60, 90, 120, 150, 180, 210 minutes post extubation, then postoperatively at 1 and 2 hours.)
- Surgeon satisfaction about the field(within 2 hours from the end of surgery.)
- Sedation(at 0, 2, 4, 6, 12, 24 hours postoperatively)
- The number of transfused blood unites(intraoperative)
- Postoperative pain(at 0, 2, 4, 6, 12, 24 hours postoperatively.)
- The total morphine consumption(in the 1st 24 hours postoperatively)
研究者
Alaa Mazy Mazy
Associate professor of anesthesia and surgical intensive care
Mansoura University