Fentanyl Effect on Blood Pressure in Elderly Patients After Induction of General Anesthesia
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 105
- 试验地点
- 1
- 主要终点
- Development of hypotension
研究概览
简要总结
Hypotension is frequently encountered after induction of general anesthesia. It can be pronounced in elderly patients and can require administration of vasopressor agents including ephedrine and phenylephrine. Intraoperative hypotension, especially prolonged episodes, can contribute to an increase in morbidity and mortality in the postoperative period as suggested by some former studies. The investigators hypothesize that fentanyl can contribute to the decrease in blood pressure (BP) that is seen after induction of general anesthesia in older patients. This hypotension may be due to fentanyl blocking effect on the sympathetic nervous system.
This study will be the first one to examine the effect of fentanyl administration on blood pressure in elderly patients with induction of general anesthesia prior to the start of surgery. If the study shows that fentanyl contributes to hypotension during this period, it may lead to a change in practice and better patient outcomes and mortality rates.
详细描述
This is a prospective double-blinded randomized controlled trial (RCT) where patients will be assigned randomly by the investigational pharmacist. Patients will be assigned to one of three groups: (1) A control group that receives 0.9 mcg/kg sodium chloride (NaCL), (2) a fentanyl group that receives 1 mcg/kg fentanyl, or (3) a fentanyl group that receives 2 mcg/kg fentanyl.
The definition of intraoperative hypotension in this study is defined as a mean blood pressure (MAP) less than 25% compared to the baseline value (i.e., the participants' first blood pressure reading after entering the operating room). All study drug agents will be dispensed by the pharmacy in five milliliter syringes labeled as "study medication". The volume of any of the three study medication will be adjusted by the pharmacist to reflect an equal volume.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 60 years and older
- •Patients coming from home (including those who will be admitted post-operatively)
- •Surgeries with general anesthesia alone or if combined with peripheral nerve blocks
- •Patients must be seen at the Russo operating room at Loyola Medical Center (Maywood, IL)
排除标准
- •Age less than 60
- •Patient refusal
- •Inpatient or emergency cases
- •Patients having combined general anesthesia and epidural anesthesia
- •Patients with a pre-induction mean arterial blood pressure (MAP) less than 50 or greater than 150
- •Patients who will receive rapid sequence induction with succinylcholine
- •Patients scheduled for cardiovascular surgery
- •Patients scheduled for inhalational induction
- •Patients with weight greater than 125 kg
- •Patients with a history of chronic opioid use
研究组 & 干预措施
Control
Individuals assigned to this condition will receive 0.9 mcg/kg sodium chloride (NaCL)
干预措施: Sodium chloride (Drug)
Low Dose
Individuals assigned to this condition will receive 1 mcg/kg fentanyl
干预措施: Fentanyl (Drug)
High Dose
Individuals assigned to this condition will receive 2 mcg/kg fentanyl
干预措施: Fentanyl (Drug)
结局指标
主要结局
Development of hypotension
时间窗: At 60 minutes following dose administration
Blood pressure will be recorded 60 minutes after administration of the study agent
次要结局
未报告次要终点
研究者
Jeffrey Hartwig
Assistant Professor
Loyola University