Comparison of Postoperative Morphine Requirements Between Two Magnesium Sulfate Administration Protocols in Opioid-Free Anesthesia for Bariatric Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Total postoperative morphine consumption (mg) within 48 hours after surgery
研究概览
简要总结
This retrospective observational study aims to compare postoperative morphine consumption in patients undergoing bariatric surgery with opioid-free anesthesia (OFA) using two different intravenous magnesium sulfate administration protocols: a single bolus versus a bolus followed by continuous infusion. Medical records of 110 patients operated between June 2022 and December 2023 at Hospital HM Nou Delfos were reviewed. All patients received standardized OFA, and only the magnesium protocol varied between the groups. The primary objective was to evaluate total morphine consumption during the first 48 hours postoperatively. Secondary outcomes included pain scores, antiemetic use, and adverse events. This study was approved by the hospital's Research Ethics Committee (Protocol V3_12.05.2025).
详细描述
This is a retrospective, single-center, observational study conducted at Hospital HM Nou Delfos (Barcelona, Spain), which compares the effect of two intravenous magnesium sulfate (MgSO₄) administration protocols on postoperative opioid requirements in patients undergoing bariatric surgery under opioid-free anesthesia (OFA).
The two magnesium protocols evaluated were:
Group A: MgSO₄ bolus 40 mg/kg administered before induction.
Group B: MgSO₄ bolus 50 mg/kg before induction followed by continuous infusion of 15 mg/kg/h until the end of surgery.
All patients underwent standardized OFA including propofol, lidocaine, ketamine and dexmedetomidine. No intraoperative opioids were administered. Multimodal postoperative analgesia was provided in all cases(dexamethasone, paracetamol, and dexketoprofen).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 65 years
- •Body mass index (BMI) ≥ 30 kg/m²
- •ASA physical status II or III
- •Underwent laparoscopic bariatric surgery (sleeve gastrectomy or Roux-en-Y gastric bypass) under opioid-free total intravenous anesthesia
排除标准
- •Pregnancy or breastfeeding
- •Chronic opioid use before surgery
- •Known allergy to magnesium sulfate or any drug used in the anesthetic protocol
- •Severe renal or hepatic insufficiency
- •Untreated coagulopathy
- •Active substance abuse
- •Uncontrolled psychiatric disorders
- •Intraoperative complications requiring deviation from the protocol
- •Postoperative morphine consumption exceeding institutional standards
结局指标
主要结局
Total postoperative morphine consumption (mg) within 48 hours after surgery
时间窗: 0-48 hours after surgery
Total amount of morphine administered within 48 hours after surgery, measured in milligrams, as recorded in the post-anesthesia care unit and hospital stay.
次要结局
- Pain intensity using Visual Analog Scale (VAS)(1, 2, 4, 24, and 48 hours postoperatively)
- Incidence of adverse events(Up to 48 hours after surgery)
- Sleep quality reported by the patient(Within 24 hours after surgery)
- Patient satisfaction with anesthesia(Within 24 hours after surgery)
- Length of hospital stay(Up to 5 days after surgery)
研究者
HIPÓLITO LABANDEYRA GONZALEZ
Anesthesiologist
Hospital HM Nou Delfos