Идёт набор NCT06487988

Asleep Fiberoptic vs Direct Laryngoscopy Effect on Hemodynamic Stability Using Opioid Free Anesthesia Induction

Без фазы С лечением Analgesics, Opioid Anesthesia, General Heart Rate Blood Pressure

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: direct conventional laryngoscopy, fiberoptic guided intubation.
Кому может быть актуально: Состояния в реестре: Analgesics, Opioid, Anesthesia, General, Heart Rate, Blood Pressure. Базовые параметры: 18 лет — 55 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: Ливан
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

The goal of this clinical trial is to compare blood pressure and heart rate between the fiberoptic and direct oral intubation using opioid free anesthesia induction. Secondary objectives include comparing the time needed for intubation and the incidence of postoperative sore throat, hoarseness, and upper airway trauma in adults aging between 18 to 55 years, scheduled for elective surgery under general anesthesia. The main question it aims to answer is: Does fiberoptic intubation cause less hemodynamic instability than direct oral intubation using opioid free anesthesia induction?

Подробное описание

Background: Intubation has always been linked to a transient increase in blood pressure and heart rate that could be deleterious in elderly and hemodynamically unstable patients. Fiberoptic intubation, which is currently used for suspected difficult intubation, could cause less marked rise in blood pressure and heart rate. Furthermore, "opioid free anesthesia" has gained popularity lately to avoid opioid adverse effects ranging from respiratory depression, postoperative ileus, sedation, nausea, vomiting and urinary retention.

Specific aims: The primary objective of this study is to compare blood pressure and heart rate between the fiberoptic and direct oral intubation using opioid free anesthesia induction. Secondary objectives include comparing the time needed for intubation and the incidence of postoperative sore throat, hoarseness, and upper airway trauma.

Methods: In this prospective randomized clinical trial, 90 (45 in each group) adults aging between 18 to 55 years, scheduled for elective surgery under general anesthesia, will be recruited over 1 year of work. Patients will be randomly allocated to 2 groups: The direct conventional laryngoscopy group performed with N3 (for females) or N4 (for males) Macintosh laryngoscope blade, and the fiberoptic guided intubation group.

Significance: Studies comparing hemodynamic stability using fiberoptic intubation versus direct oral intubation in opioid free anesthesia are limited. The present study will assess whether fiberoptic intubation causes less hemodynamic instability than direct oral intubation in opioid free anesthesia induction, which will benefit patients with normal airways.

Вмешательства

Устройство direct conventional laryngoscopy
direct conventional laryngoscopy will be performed with N3 (for females) or N4 (for males) Macintosh laryngoscope blade.
Устройство fiberoptic guided intubation
fiberoptic guided intubation will be performed.

Первичные конечные точки

Heart rate [Срок оценки: baseline and up to 5 mins upon intubation]
Blood pressure [Срок оценки: baseline and up to 5 mins upon intubation]

Вторичные конечные точки (3)

time needed for intubation [Срок оценки: between face mask removal and first ETCO2 reading in minutes]
incidence of postoperative sore throat [Срок оценки: after 24 hrs]
incidence of upper airway trauma [Срок оценки: during intubation]

Критерии участия

Критерии включения

ASA (American Society of Anesthesiologists) physical status I and II
Range age of 18-55 years' old
Scheduled for elective surgery under general anesthesia.

Критерии исключения

History of cardiovascular diseases.
History of lung disease.
Hypertensive patient (BP> 140/90)
Patient taking medications that affect blood pressure and heart rate
Morbid obesity (BMI >30)
Severe GERD
Predicted difficult airway (Short TMD <6 cm, Upper li bite test grade III, Mallampati score

>III)