Deep Versus Moderate Neuromuscular Blockade in Bariatric Surgery

Официальное название

Deep Versus Moderate Neuromuscular Blockade in Bariatric Surgery:

Обзор

The aim of this study is to investigate the effect of depth of neuromuscular blockade on the surgical field, patient postoperative pain, intestinal motility, the incidence of postoperative nausea and vomiting and the effect of deep versus moderate neuromuscular blockade on postoperative atelectasis quantitatively using chest computed tomography.This is a prospective, randomized, controlled clinical-controlled study in patients ≥18 years old scheduled to undergo elective bariatric surgery.

Вмешательства

• Препарат Deep neuromascular blockage
  maintenance of a deep neuromuscular block with rocuronium, titrated to maintain a TOF count of 0, and a PTC between 1-2. Quality of surgical field conditions' assessed by a blind surgeon as a 5 points scale(Leiden scale : 1 indicates extremely poor conditions, 2 poor conditions, 3 acceptable conditions, 4, good conditions and 5 optimal conditions)
• Препарат Moderate neuromascular blockage
  maintenance of a moderate neuromuscular block with rocuronium, titrated to maintain a TOF count of 1-2

Первичные конечные точки

• impact of a deep neuromuscular blockade on surgical conditions [Срок оценки: During surgery]

Вторичные конечные точки (12)

• the effect of deep versus moderate neuromuscular blockade on postoperative atelectasis quantitatively using chest computed tomography. [Срок оценки: in the first six postoperative hours]
• Postoperative pain [Срок оценки: first postoperative day]
• Mean arterial pressure (mmHg) [Срок оценки: intraoperative and in Postanesthesia care unit]
• PIPcmH20 ( Peak inspiratory pressure) [Срок оценки: intraoperative]
• duration of surgery (hr) [Срок оценки: intrapostoperative]
• The first flatus time (min) [Срок оценки: up to 5 days]
• duration of anesthesia time (min) [Срок оценки: intraoperative]
• Postoperative nausea and vomiting (PONV) [Срок оценки: until first postoperative day]
• Hospitalization time ( days) [Срок оценки: up to 2 weeks]
• cumulative analgetid dose (mg) [Срок оценки: until 2 PM the next day of the surgery]
• oxygen saturation (SpO2) % [Срок оценки: intraoperative and in Postanesthesia care unit]
• tidal volume (ml) [Срок оценки: Intraoperative]

Критерии участия

Критерии включения

• Patients aged ≥18 years ASA II-III who are to undergo planned laparoscopic bariatric surgery

Критерии исключения

• ASA 4 patients
• Maternal population
• Patients who are not scheduled to receive general anesthesia, but some other type of anesthesia.
• Contraindicated patients: administration of neuromuscular blockade, suppression of spontaneous respiration, and those with an indication for awake intubation or surgical airway.
• Patients with neuromuscular diseases
• Patients who refuse to participate in the study.

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

Простое слепое

Основная цель

Поддерживающая терапия

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06553066 · Bariatric

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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