Intermittent Boluses Versus Infusion of Propofol During Gastroscopy

Официальное название

Intermittent Boluses Versus Continuous Infusion of Propofol During Standard Upper Endoscopy

Обзор

It is unclear whether continuous infusion or intermittent bolus injection of propofol is better for achieving adequate sedation during a standard upper endoscopy. The study aimed to compare the efficacy and safety of continuous infusion and intermittent bolus injection of Propofol (Diprivan) during a standard upper endoscopy. In this prospective study, patients will be randomly assigned to undergo a standard upper endoscopy with either continuous infusion (CI group) or intermittent bolus injection (BI group) of Propofol (Diprivan) administered by an anesthesiologist. The primary outcome will be to assess the quality of sedation by the endoscopist (VAS). In addition to other sedation-related parameters that will include sedation induction time (minutes), total dose of propofol (mg), recovery time (minutes) using Aldrete score, any involuntary patient movement, and adverse events.

Подробное описание

Patients of both genders, aged between 18 and 85 years old and referred to standard upper endoscopy at Luzmila Hospital will be included in the study. Patients who are pregnant, have known allergies to the drugs used or a history of sedation-related complications (i.e., severe paradoxical response, hypoxemia, bradycardia, and hypotension) or gastrectomy, are American Society of Anesthesiologist (ASA) class ≥ IV (11), or are unable to provide informed consent will be excluded from participating in the study. The patients undergoing a standard upper endoscopy will be randomly assigned to either continuous infusion (CI group) of propofol (Diprivan) with induction using benzodiazepine (2 mg Dormicum i.v.) or only intermittent bolus injection (BI group) of propofol (Diprivan) infused by an anesthesiologist. BI was defined by intermittent use of 20 mg propofol (Diprivan) boluses on demand, with a minimum period of 30 seconds between boluses to evaluate the effect of the drug. CI was defined by continuous propofol (Diprivan) infusion at a 3 mg/ kg/h rate.

The anesthesiologist will follow up the patient during the first observation period, the average time spent in the recovery area and register the requied data during the procedure using Aldrete score (a post anesthesia recovery score where a minimum score of 8 is required for discharge).

The patients' identities will be coded and the data will be kept confidential. The study protocol will be performed according to the Decalrations of Helsinki and will be applied for approval by the Institutional Review Board at Al-Balqa Applied University. Written informed consent was obtained from all patients.

Вмешательства

• Препарат Propofol 100 MG in 10 ML Injection
  Sedation induction time (minutes), total dose of propofol (mg), recovery time (minutes), any involuntary patient movement, quality of sedation (VAS) and adverse events

Первичные конечные точки

• Sedation induction time (minutes) [Срок оценки: 30 minutes]
• Total dose of propofol (mg) [Срок оценки: 30 minutes]
• Recovery time (minutes) [Срок оценки: 30 minutes]

Вторичные конечные точки (3)

• Involuntary movement [Срок оценки: 30 minutes]
• Quality of sedation [Срок оценки: 30 minutes]
• Adverse events [Срок оценки: 30 minutes]

Критерии участия

Критерии включения

• Patients of both genders
• Age between 18 and 85 years old
• Referred to standard upper endoscopy at Luzmila Hospital

Критерии исключения

• Patients who are pregnant,
• Known allergies to the used drugs
• History of sedation-related complications (i.e., severe paradoxical response, hypoxemia, bradycardia, and hypotension)
• Previous history of gastrectomy,
• Patients are American Society of Anesthesiologist (ASA) class ≥ IV ,
• Patients are unable to provide informed consent

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

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• ASGE Standards of Practice Committee; Early DS, Lightdale JR, Vargo JJ 2nd, Acosta RD, Chandrasekhara V, Chathadi KV, Evans JA, Fisher DA, Fonkalsrud L, Hwang JH, Khashab MA, Muthusamy VR, Pasha SF, Saltzman JR, Shergill AK, Cash BD, DeWitt JM. Guidelines for sedation and anesthesia in GI endoscopy. Gastrointest Endosc. 2018 Feb;87(2):327-337. doi: 10.1016/j.gie.2017.07.018. Epub 2018 Jan 3. No ab PMID 29306520
• Riphaus A, Geist C, Schrader K, Martchenko K, Wehrmann T. Intermittent manually controlled versus continuous infusion of propofol for deep sedation during interventional endoscopy: a prospective randomized trial. Scand J Gastroenterol. 2012 Sep;47(8-9):1078-85. doi: 10.3109/00365521.2012.685758. Epub 2012 May 28. PMID 22631051

Идентификаторы

NCT: NCT06378879 · 1073/1/3/26

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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