Opioid-Free Versus Opioid-Based Anesthesia in Bariatric
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: Intraoperative rescue analgesia, Intraoperative rescue analgesia:.
- Кому может быть актуально
- Состояния в реестре: Obesity, Bariatric Surgery. 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
- Список центров уточняется — проверьте первичный протокол.
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
A Prospective, Randomized Controlled Trial Comparing Opioid-Free and Opioid-Based Anesthesia in Morbidly Obese Patients Undergoing Bariatric Surgery
Обзор
This study is designed as a prospective, randomized, controlled clinical trial. It will be conducted in the operating rooms of the University of Health Sciences, Diyarbakır Gazi Yaşargil Training and Research Hospital. Patients aged 18 to 65 years who are scheduled for elective bariatric surgery and meet the inclusion criteria (ASA physical status I-III) will be enrolled in the study. Eligible patients will be informed both verbally and in writing during their preoperative anesthetic evaluation, and written informed consent will be obtained at least 24 hours prior to surgery. Patients will be randomly assigned to one of two groups using computer-generated randomization: Group O (Opioid group) Group NO (Opioid-free group) All patients will receive 40 mg IV pantoprazole and 4 mg IV ondansetron 30 minutes before surgery as preoperative medication. Standard ASA monitoring will be applied, and fasting guidelines will be followed. Depth of anesthesia will be monitored in all patients using BIS, and maintained within a target range of BIS 40-60 to ensure adequate depth with no response to surgical stimuli.
Подробное описание
This study is designed as a prospective, randomized, controlled clinical trial. It will be conducted in the operating rooms of the University of Health Sciences, Diyarbakır Gazi Yaşargil Training and Research Hospital. Patients aged 18 to 65 years who are scheduled for elective bariatric surgery and meet the inclusion criteria (ASA physical status I-III) will be enrolled in the study.
Eligible patients will be informed both verbally and in writing during their preoperative anesthetic evaluation, and written informed consent will be obtained at least 24 hours prior to surgery.
Patients will be randomly assigned to one of two groups using computer-generated randomization:
Group O (Opioid group)
Group NO (Opioid-free group)
All patients will receive 40 mg IV pantoprazole and 4 mg IV ondansetron 30 minutes before surgery as preoperative medication. Standard ASA monitoring will be applied, and fasting guidelines will be followed. Depth of anesthesia will be monitored in all patients using BIS, and maintained within a target range of BIS 40-60 to ensure adequate depth with no response to surgical stimuli.
Anesthesia Protocol:
Group O (Opioid Group):
General anesthesia will be induced with 2 mg/kg propofol, 2 µg/kg fentanyl, and 0.6 mg/kg rocuronium based on ideal body weight (IBW). Maintenance will be achieved using remifentanil (Ultiva®) infusion at 0.1-0.3 µg/kg/min and 1 MAC sevoflurane. Following induction, all patients will receive a bilateral transversus abdominis plane (TAP) block under ultrasound guidance using 40 mL of 0.25% bupivacaine.
Group NO (Opioid-Free Group):
General anesthesia will be induced with 2 mg/kg propofol, 0.5 mg/kg ketamine, and 0.6 mg/kg rocuronium (IBW). Anesthesia will be maintained with dexmedetomidine infusion at 0.2-1.4 µg/kg/h and 1 MAC sevoflurane. Following induction, a bilateral TAP block will also be performed using 40 mL of 0.25% bupivacaine under ultrasound guidance.
Postoperative Analgesia Protocol:
During skin closure, all patients will receive 1 g IV paracetamol and 50 mg IV ketoprofen. At the end of surgery, neuromuscular blockade will be reversed using sugammadex, and patients will be safely extubated.
In the postoperative period, patients will be followed in the surgical ward for 48 hours with a standardized analgesic protocol:
1 g IV paracetamol every 6 hours
4 mg IV ondansetron every 8 hours
50 mg IV ketoprofen every 12 hours
Pain will be assessed using the Visual Analog Scale (VAS). If VAS ≥ 4, 100 mg IV tramadol will be administered as rescue analgesia, and all interventions will be documented in the patient records.
Вмешательства
- Препарат Intraoperative rescue analgesia
If signs of inadequate analgesia occur (e.g., \>20% increase in heart rate or blood pressure), IV remifentanil infusion rate will be titrated upward within the safety margin. - Препарат Intraoperative rescue analgesia:
If signs of inadequate analgesia occur (e.g., \>20% increase in heart rate or blood pressure), IV dexmedetomidine infusion rate will be titrated upward (up to maximum safe dose).
Первичные конечные точки
- Postoperative VAS pain scores [Срок оценки: post-op 1.hour (H), 2.H, 3.H, 6.H, 12.H, 18.H, 24.H, 36.H and 48.H]
- QoR-15 score (Quality of Recovery) [Срок оценки: 24 Hours and 48 Hours]
Вторичные конечные точки (2)
- Rescue analgesic requirement [Срок оценки: Within 48 hours post-op]
- Postoperative nausea and vomiting (PONV) incidence questionnaire [Срок оценки: 48 hours]
Критерии участия
Критерии включения
Age 18-65 years
BMI >35
ASA class III-IV
Elective bariatric surgery (e.g., sleeve gastrectomy)
Written informed consent
Критерии исключения
Refusal to participate
Severe cardiac/pulmonary/psychiatric illness
Allergy to study drugs
Conversion to emergency surgery
Withdrawal at any point by patient or investigator
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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
- Профилактика
Центры проведения
Список центров уточняется — проверьте первичный протокол.
Идентификаторы
NCT: NCT07105839 · OBES-OFAN-2025-01