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Набор скоро начнётся NCT07460050

Comparison of Two Sedative Agents in Terms of Controlled Hypotension

Без фазы С лечением Controlled Hypotension for Nasal Surgeries

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: Propofol, Isoflurane.
Кому может быть актуально
Состояния в реестре: Controlled Hypotension for Nasal Surgeries. Базовые параметры: 18 лет — 65 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
Пакистан
Следующий шаг
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Официальное название

COMPARISON OF PROPOFOL INFUSION VS INHALATIONAL AGENT ISOFLURANE IN TERMS OF CONTROLLED HYPOTENSION IN PATIENTS UNDERGOING ENDOSCOPIC SINUS SURGERY

Обзор

Propofol and Isoflurane are commonly used sedative agents in general anaesthesia.Both these drugs have a side effect of decreasing blood pressure which when used optimally can be used to acheive controlled hypotention. So, it provides a better visiblity of surgical filed to the surgeons.This RCT compares propofol infusion vs isoflurane inhalation for inducing controlled hypotension during endoscopic sinus surgery. The goal is to assess which agent better controls blood pressure, improves surgical field visibility, and impacts recovery. It likely measures outcomes like hemodynamics, bleeding, and surgeon satisfaction.

Подробное описание

Propofol is a rapid-acting, intravenous sedative-hypnotic agent used for the induction and maintenance of general anesthesia, procedural sedation, and sedation for mechanically ventilated ICU patients. It acts by enhancing GABAergic inhibition in the brain, offering quick onset and short duration of action.

Isoflurane is a widely used halogenated ether inhalational agent for the induction and maintenance of general anesthesia functions as a central nervous system depressant by interacting with various receptors, including GABA, glutamate, and glycine receptors, to produce anesthesia. Both agents have side effect of hypotention which is useful during surgery for controlled hemodynamics, surgical field visibility and better recovery but evidence regarding their comparative effectiveness remains inconsistent. So i am comparing propofol infusion vs isoflurane for controlled hypotension in endoscopic sinus surgery. This randomized controlled trial will be conducted in the Department of Anaesthesiology, PGMI/ Hayatabad Medical Complex, Peshawar. A total of 136 adult patients with ASA physical status l -ll , scheduled for elective endoscopic sinus surgery under general anaesthesia will be enrolled and randomized into two equal groups. Group P will receive Propofol infusion at a dose starting at 12mg/kg/ hr titrated to the desire effect(target MAP 60-70 mmHg) while Group I will receive isoflurane inhalation (1-2% end-tidal, same MAP target). Outcomes like Surgical field quality , blood loss, recovery time, hemodynamic stability, side effects (shivering, nausea) will be observed and noted

Вмешательства

  • Препарат Propofol
    Intravenous propofol infusion (starting dose 12mg/kg/hr and titrated accordingly) given to patients as sedative undergoing endscopic sinus surgery for hemodynamic stability
  • Препарат Isoflurane
    Isoflurane inhalation (1-2% end tidal) used in patients as sedative undergoing endoscopic sinus surgery for hemodynamic stability

Первичные конечные точки

  • Surgical field visibility [Срок оценки: The surgical field visibility time frame for propofol vs isoflurane during endoscopic sinus surgery assessed intraoperatively is usually 30-60mins postinduction]
  • Surgical field visibility [Срок оценки: The surgical field visibility time frame assessed intraoperatively during endoscopic sinus surgery is usually 30- 60 mins post induction]

Критерии участия

Критерии включения

  • Either male/female Age 18-65 Patients undergoing endoscopic sinus surgery as per the operational definition

Критерии исключения

  • Patients with cardiovascular disease Patients with pregnancy Patients with coagulopathy Patients on beta blockers or calcium channel blockers

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Профилактика

Центры проведения

Пакистан · 1 центр
  • Hayatabad Medical Complex, Peshawar — Peshawar

Идентификаторы

NCT: NCT07460050 · ISO-PROP-01

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗