Prospective Randomized Trial of Moderate vs Deep Neuromuscular Blockade During Laparoscopic Ventral Hernia Repair
The proposed study aims to assess the effect of different levels of muscle relaxation on the success of low-pressure insufflation, surgical conditions and patient recovery following laparoscopic repair of a ventral hernia (VHR) between 2 and 10cm in diameter. Patients will be randomized to moderate (TOF 1-2) or deep (post tetanic count 1-2) relaxation.
Specific Aim 1. Compare two different modes of neuromuscular blockade (moderate and deep) on the ability to maintain low insufflation pressure during laparoscopic VHR. All procedures will start with low-pressure insufflation (8 mm Hg). Surgeon assessment of the conditions will be serially performed during surgery on an established visual scale. If conditions are deemed less than adequate (score 1-2), insufflation pressure will incrementally increase up to 15 mm Hg. Outcome for this specific aim will be the mean insufflation pressure during each procedure, and the ability to perform low-pressure laparoscopic VHR.
Specific Aim 2. Evaluate the success of moderate neuromuscular blockade on the ability to maintain good conditions (visual scale grade 4 or 5) for each. Surgical conditions will be considered successful when scores are maintained at 4 or 5 throughout the duration of the procedure. Outcome for this aim will be the mean score for surgical condition assessment for each procedure, using a previously published surgeon-driven scoring system (score 4-5 will be used as a surrogate of good visualization).
Specific Aim 3. Assess patient recovery with low and high insufflation pressures during laparoscopic VHR. Patient overall satisfaction with recovery, pain level, pain medication requirement, PONV incidence and severity will be assessed in multiple time points following surgery. Outcomes for this aim will be mean pain (visual scale), PONV severity (analogue score) and incidence (binary outcome), and patient satisfaction using the QoR-15 survey. Assessments will be performed at 30 minutes, 1, 12 and 24 hours following surgery.
Обзор исследования
Статус
Тип исследования
Регистрация (Ожидаемый)
Фаза
- Непригодный
Контакты и местонахождение
Места учебы
-
-
New York
-
Stony Brook, New York, Соединенные Штаты, 11794-8191
- Рекрутинг
- Shabana Humayon
-
Контакт:
- Shabana Humayon
- Номер телефона: 631-532-7167
- Электронная почта: shabana.humayon@stonybrookmedicine.edu
-
Главный следователь:
- Konstantinos Spaniolas
-
-
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
- Patients age 18-75 years old
- Umbilical, ventral, epigastric, spigelian or incisional hernia
- Plan for laparoscopic ventral hernia repair with mesh
- Estimated fascial defect between 2-10 cm in maximum diameter
Exclusion Criteria:
- Allergy to medications delineated in the protocol (muscle blockade, anesthetics, reversal agents)
- Inability to provide informed consent
- Body mass index of 35 or over
- Multiple recurrent hernias (>1)
- Creatinine clearance < 30 ml/min (using the Cockcroft-Gault calculation)
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Одинокий
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: Moderate Neuromuscular Block
Train of four count of 1-2.
All procedures will start with low-pressure insufflation (8 mm Hg).
Surgeon assessment of the conditions will be serially performed during surgery on an established visual scale.
If conditions are deemed less than adequate (score 1-2), insufflation pressure will incrementally increase up to 15 mm Hg.
Reversal of muscle relaxation will be performed at the end of the procedure using established medications used in clinical practice.
In theory, deep relaxation may require a more prolonged reversal process, but using contemporary medical agents (sugammadex), reversal from deep relaxation is prompt (2-3 minutes) without any additional delays.
|
All procedures will start with low insufflation pressure (8 mmHg).
Surgical field assessment (scale 1-5) will be performed every 5 minutes (Martini Br J Anaesth 2014).
If conditions are poor (rating 1-2), intraperitoneal insufflation will be incrementally increased (10 mmHg, 12 mmHg, 15 mmHg) every 5 minutes as needed.Reversal of muscle relaxation will be performed at the end of the procedure using established medications used in clinical practice.
In theory, deep relaxation may require a more prolonged reversal process, but using contemporary medical agents (sugammadex), reversal from deep relaxation is prompt (2-3 minutes) without any additional delays.
|
|
Экспериментальный: Deep Neuromuscular Block
Post tetanic count of 1-2.
All procedures will start with low-pressure insufflation (8 mm Hg).
Surgeon assessment of the conditions will be serially performed during surgery on an established visual scale.
If conditions are deemed less than adequate (score 1-2), insufflation pressure will incrementally increase up to 15 mm Hg.
Reversal of muscle relaxation will be performed at the end of the procedure using established medications used in clinical practice.
In theory, deep relaxation may require a more prolonged reversal process, but using contemporary medical agents (sugammadex), reversal from deep relaxation is prompt (2-3 minutes) without any additional delays.
|
All procedures will start with low insufflation pressure (8 mmHg).
Surgical field assessment (scale 1-5) will be performed every 5 minutes (Martini Br J Anaesth 2014).
If conditions are poor (rating 1-2), intraperitoneal insufflation will be incrementally increased (10 mmHg, 12 mmHg, 15 mmHg) every 5 minutes as needed.Reversal of muscle relaxation will be performed at the end of the procedure using established medications used in clinical practice.
In theory, deep relaxation may require a more prolonged reversal process, but using contemporary medical agents (sugammadex), reversal from deep relaxation is prompt (2-3 minutes) without any additional delays.
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Временное ограничение |
|---|---|
|
Mean insufflation pressure during each procedure as a continuous variable
Временное ограничение: will be assessed every 5 minutes during surgery (while subject is undergoing laparoscopic ventral hernia repair)
|
will be assessed every 5 minutes during surgery (while subject is undergoing laparoscopic ventral hernia repair)
|
Вторичные показатели результатов
Мера результата |
Временное ограничение |
|---|---|
|
Surgical condition assessment
Временное ограничение: every 5 minutes during surgery (while subject is undergoing laparoscopic ventral hernia repair)
|
every 5 minutes during surgery (while subject is undergoing laparoscopic ventral hernia repair)
|
|
PONV severity (analogue score) and incidence (binary)
Временное ограничение: it will be assessed at 30 minutes, 1 hour, 12 hours and 24 hours after the completion of laparoscopic ventral hernia repair
|
it will be assessed at 30 minutes, 1 hour, 12 hours and 24 hours after the completion of laparoscopic ventral hernia repair
|
|
Patient satisfaction (QoR-15).
Временное ограничение: it will be assessed 24 hours after the completion of laparoscopic ventral hernia repair
|
it will be assessed 24 hours after the completion of laparoscopic ventral hernia repair
|
Соавторы и исследователи
Спонсор
Соавторы
Следователи
- Главный следователь: Konstantinos Spaniolas, MD, StonyBrook University Hospital
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Ожидаемый)
Завершение исследования (Ожидаемый)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- 1034023-3
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
продукт, произведенный в США и экспортированный из США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .