Preoperative Oral Heptaminol Hydrochloride in Preventing Hypotension After Spinal Anesthesia in Lower Limb Surgeries With Tourniquet: A Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 160
- 主要终点
- Hypotension
研究概览
简要总结
Methodologies and approaches have been implemented with differing degrees of success to prevent neuraxial hypotension. Currently utilized approaches to prevent hypotension during spinal anesthetic administration consist of physical precautions such as leg restraints and compression hosiery, as well as sympathomimetic medications Through a competitive inhibition of noradrenaline uptake, heptaminol hydrochloride prevented orthostatic hypotension and increased the plasma concentration of noradrenaline. This inhibitory effect might account for a portion of the antihypotensive effect After thorough research of the literature, studies evaluating the role of preoperative oral heptaminol hydrochloride in preventing hypotension after spinal anesthesia in lower limb surgeries with tourniquets are lacking.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age from 18 to 50 years old.
- •Both sexes.
- •American Society of Anesthesiologists (ASA) physical status I-II.
- •Undergoing elective orthopedic lower limb operations with a tourniquet or plastic surgeries under spinal anesthesia.
排除标准
- •Patient refusal.
- •History of hypertension, cardiovascular [disorders of the heart and blood vessels and including coronary heart disease, rheumatic heart disease and other conditions], and cerebrovascular diseases [conditions that affect blood flow and the blood vessels in the brain. Problems with blood flow may occur from blood vessel narrowing (stenosis), clot formation (thrombosis), artery blockage (embolism), or blood vessel rupture (hemorrhage)].
- •Baseline SBP >160 mm Hg before administration of the drug.
- •Any contraindications to spinal anesthesia such as coagulopathy, local skin infection, swelling, trauma, or deformity.
- •Medical conditions, which release vasoconstrictors such as pheochromocytoma.
- •Patients taking vasoconstrictors or uncorrected tachyarrhythmia.
- •History of drug allergy.
- •Psychiatric, neuromuscular disorder, major systemic diseases.
- •Pregnancy or lactating women.
- •Inadequate effect of spinal anesthesia or supplemented with other types of anesthesia.
研究组 & 干预措施
Heptaminol hydrochloride group
干预措施: Heptaminol Hydrochloride (Drug)
Placebo group
干预措施: Placebo (Drug)
结局指标
主要结局
Hypotension
时间窗: It will be assessed in the first 20 minutes after spinal anaesthesia
The occurrence of hypotension is defined as SBP \<90 mm Hg or \<80% of baseline, after spinal anesthesia. Our hypotension outcome was a binary event (yes/no) defined as the occurrence of at least 1 episode for a patient below either threshold, versus none, across the repeated measurements.
次要结局
- Changes in mean arterial blood pressure after spinal anesthesia(Every 5 minutes in the first 20 minutes after spinal anesthesia then every 15 minutes until the end of operation assessed up to 3 hours after spinal anesthesia)
- Changes in heart rate after spinal anesthesia(Every 5 minutes in the first 20 minutes after spinal anesthesia then every 15 minutes until the end of operation assessed up to 3 hours after spinal anesthesia)
研究者
AbdElKhalik Mahmoud Shaban
Lecturer of anaesthesia
Cairo University