Deep Neuromuscular Block With Low Pressure Pneumoperitoneum in Laparoscopic Abdominal Surgeries: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- The degree of pain
研究概览
简要总结
The aim of this study is to evaluate the effect of deep neuromuscular block on postoperative pain, duration of surgery, quality of surgical field, length of recovery room stays, Total amount of rescue analgesic, postoperative nausea/vomiting, and length of hospital stay.
详细描述
Acute-pain management in surgery patients is accompanied by an array of negative consequences, including increased morbidity, impaired physical function, and quality of life, slowed recovery, prolonged opioid use during and after hospitalization, and increased cost of care.
Reducing pneumo-peritoneum (PP) is one technique for reducing postoperative pain. The effect of low PP on postoperative pain remains a controversial topic with other studies reporting no difference in postoperative pain levels between the Two pressures.
Deep neuromuscular block (DNMB) in abdominal surgeries is associated with various advantages, such as lower abdominal pressure, lower pain and rescue opioid consumption, as well as less bleeding. DNMB may facilitate the use of reduced insufflation pressure without compromising the surgical field of vision. However, its usage is limited due to a lack of predictable and rapid recovery with conventional NMB antagonists (neostigmine) or spontaneous recovery
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
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 18 to 65 years old.
- •Both sexes.
- •American Society of Anesthesiologists (ASA) physical status I-III.
- •Patients scheduled for laparoscopic abdominal surgery.
排除标准
- •Known allergies to cis-atracurium or neostigmine.
- •Contraindications to the use of neostigmine, such as bronchial asthma, glaucoma, myocardial ischemia, and epilepsy.
- •History of neuromuscular, renal, or hepatic disease; previous abdominal surgery.
- •Treatment with drugs known to affect neuromuscular function.
- •Preoperative hyperalgesia.
- •Peripheral neuropathy is caused by diabetes.
- •History of chronic analgesics treatment, drug, or alcohol abuse.
- •Body mass index (BMI) > 35 kg/m2.
结局指标
主要结局
The degree of pain
时间窗: 48 hours postoperatively
The degree of pain will be evaluated using the numerical rating scale (NRS) from (0 to 10), zero means no pain and ten means the worst pain. It will be measured at PACU, 1h, 2h. 4hr, 6h, 8h, 12h, 18h, 24h, 36h and 48h postoperative.
次要结局
- The degree of Patient satisfaction(48 hours postoperatively)
- Total opioid consumption in 1st 48h(48 hours postoperatively)
- Time of first analgesic(48 hours postoperatively)
研究者
ِAhmed Mohamed Ibrahim
Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine
Tanta University