Preoperative Oral Heptaminol Hydrochloride in Preventing Hypotension After Spinal Anesthesia

Официальное название

Preoperative Oral Heptaminol Hydrochloride in Preventing Hypotension After Spinal Anesthesia in Lower Limb Surgeries With Tourniquet: A Randomized Controlled Trial

Обзор

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.

Вмешательства

• Препарат Heptaminol Hydrochloride
  heptaminol hydrochloride will be administrated in its solution form 4ml/kg. The mean dose used will be 25 drops = 150 mg and will be given 1.5 to 2 hours before spinal anesthesia
• Препарат Placebo
  Placebo drops (identical to heptaminol drops, prepared by the hospital pharmacy) will be administered 1.5 to 2 hours before spinal anesthesia.

Первичные конечные точки

• Hypotension [Срок оценки: It will be assessed in the first 20 minutes after spinal anaesthesia]

Вторичные конечные точки (2)

• Changes in mean arterial blood pressure after spinal anesthesia [Срок оценки: 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 [Срок оценки: 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]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Профилактика

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06564935 · MS-186-2024

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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