Набор по приглашению NCT06930456

Comparison Between Intravenous Hydrocortisone and Ondansetron in Prevention of Post Spinal Anesthesia Hypotension

Без фазы С лечением Post Spinal Anaesthesia Hypotension

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: hydrocortisone, ondansetron, Placebo.
Кому может быть актуально: Состояния в реестре: Post Spinal Anaesthesia Hypotension. Базовые параметры: от 21 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Египет
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Intravenous Hydrocortisone Versus Ondansetron in Prevention of Post Spinal Anesthesia Hypotension in Elective Surgeries

Обзор

The purpose of this study is to assess and contrast the effectiveness of intravenous ondansetron and intravenous hydrocortisone in avoiding spinal anesthesia-induced hypotension.

Подробное описание

According to the medication investigated in this study, patients will be divided into three equal groups (40 each). Patients will receive one of the following 15 minutes before spinal anesthesia:

1. Hydrocortisone 100 mg (H group) 2. Ondansetron 8 mg (O group) 3. An identical volume of sterile distilled water (Control group) (C group).

Spinal anesthesia will be performed under complete aseptic conditions with the patient seated, a 25-gauge Quincke spinal needle is used to administer 3.5 ml of a 0.5% hyperbaric bupivacaine together with 25 micrograms of fentanyl at the L3-L4 or L4-L5 level.

Patients will lie supine with slight head elevation after the intrathecal injection is finished. Intravenous Infusion of 500 ml normal saline over the initial post spinal 30 minutes. Sensory level and motor block will be verified. Heart rate (HR), systolic (SBP), diastolic (DBP) and mean blood pressure (MBP) will be measured every 5 min for 30 min during which the patient remains in the supine position with no application of torniquet.

If the MAP drops by 20% below baseline or the systolic blood pressure falls below 90 mmHg, hypotension is recorded and will be treated with intravenous incremental doses of 5 mg ephedrine.

If the heart rate drops below 50 beats per minute, bradycardia is recorded, and atropine 0.5 mg will be administered intravenously. If ephedrine or atropine were used, only data from before their administration would be analyzed. The doses of ephedrine and atropine needed will be recorded.

Nausea, vomiting and shivering will be recorded when occur till the end of operation.

Вмешательства

Препарат hydrocortisone
A deidentified syringe (10 mL) containing 100 mg hydrocortisone will be given 15 minutes prior subarachnoid blockade. Spinal anesthesia will be performed with a 25-gauge Quincke spinal needle to administer 3.5 ml of a 0.5% hyperbaric bupivacaine plus 25 micrograms of fentanyl at the L3-L4 or L4-L5 level. Then, Patient will lie supine with slight head elevation. Intravenous Infusion of 500 ml normal saline over the initial post spinal 30 minutes. Sensory level and motor block will be verified. He
Препарат ondansetron
A deidentified syringe (10 mL) containing 8 mg ondansetron will be given 15 minutes prior subarachnoid blockade. Spinal anesthesia will be performed with a 25-gauge Quincke spinal needle to administer 3.5 ml of a 0.5% hyperbaric bupivacaine plus 25 micrograms of fentanyl at the L3-L4 or L4-L5 level. Then, Patient will lie supine with slight head elevation. Intravenous Infusion of 500 ml normal saline over the initial post spinal 30 minutes. Sensory level and motor block will be verified. Heart r
Препарат Placebo
A deidentified syringe (10 mL) containing sterile distilled water for intravenous injection will be given 15 minutes prior subarachnoid blockade. Spinal anesthesia will be performed with a 25-gauge Quincke spinal needle to administer 3.5 ml of a 0.5% hyperbaric bupivacaine plus 25 micrograms of fentanyl at the L3-L4 or L4-L5 level. Then, Patient will lie supine with slight head elevation. Intravenous Infusion of 500 ml normal saline over the initial post spinal 30 minutes. Sensory level and moto

Первичные конечные точки

hypotension [Срок оценки: 5 minutes after subarachnoid injection and every 5 minutes for 30 minutes-duration]

Вторичные конечные точки (6)

bradycardia [Срок оценки: 5 minutes after subarachnoid injection and every 5 minutes for 30 minutes-duration]
requirement of atropine or ephedrine [Срок оценки: 5 minutes after subarachnoid injection and every 5 minutes for 30 minutes-duration]
Doses of administered atropine and ephedrine [Срок оценки: 5 minutes after subarachnoid injection and every 5 minutes for 30 minutes-duration]
nausea and vomiting [Срок оценки: after subarachnoid injection till the end of operation]
shivering [Срок оценки: after subarachnoid injection till the end of operation]
blood pressure and heart rate variations [Срок оценки: 5 minutes after subarachnoid injection and every 5 minutes for 30 minutes-duration]

Критерии участия

Критерии включения

ASA I and II (physical status according to American Society of Anesthesiologists).
Patients aged 21 years or more.
Either sex.
Abdominal and lower limb operations.