NCT05220813Unknown4 期
Does Ilioinguinal Block Provide Satisfactory Analgesia During Transcatheter Aortic Valve Implantation Procedure? A Comparative Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- conversion to general anesthesia.
研究概览
简要总结
To assess the effect of iliohypogastric and ilioinguinal nerve block on the hemodynamic stability ,narcotic consumption and the rate of conversion to general anesthesia in patients undergoing transfemoral transcatheter aortic valve implantation (TF-TAVI).
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• Patients undergoing TF-TAVI.
- •Both sexes.
- •Age 18 and above
排除标准
- •• Inability to tolerate supine position as in patients with musculoskeletal disease or back pain, OR in patients with congestive heart failure or with obstructive sleep apnea.
- •Patients with severe pulmonary hypertension (PAP>60 mmhg)
- •Barrier to communications as language barrier or dementia.
- •Patients' preference of general anesthesia.
- •Surgical consideration as transapical, subclavian approach, extensive TEE requirements.
- •Patients with history of allergy to any drugs used.
- •Patients with psychiatric disease.
- •Patients with neurocognitive or neurodegenerative disease.
- •Secondary exclusion criteria include abortion of the procedure, perioperative emergency conversion to general anesthesia and the need to cardiopulmonary resuscitation so the primary endpoint couldn't be detected in these conditions.
研究组 & 干预措施
local anesthetic group (control group)
Active Comparator
44 patients will receive local infiltration anesthesia.
干预措施: Lidocaine (Drug)
ilioinguinal iliohypogastric group
Active Comparator
44patients will receive ilioinguinal iliohypogastric nerve blocks
干预措施: Bupivacain (Drug)
结局指标
主要结局
conversion to general anesthesia.
时间窗: during the procedure (intraoperatively)
Conversion to general anesthesia in other than procedure related causes.
次要结局
- fentanyl dose(during the procedure (intraoperatively))
- propofol dose(during the procedure (intraoperatively))
- sedation score(during the procedure (intraoperatively))
研究者
Ismail Mohammed
principal investigator
Ain Shams University
研究点 (1)
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