The Effect of Deep Versus Moderate Neuromuscular Blocking on Patients Undergoing Open Hysterectomy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 88
- 试验地点
- 2
- 主要终点
- change in serum levels of the estimated inflammatory cytokines
研究概览
简要总结
This study aimed for Determination of the impacts of deep neuromuscular blockade (DNMB) on surgical outcomes, consumption of perioperative opioid analgesia, and serum levels of inflammatory cytokines in comparison to moderate NMB (MNMB).
详细描述
The primary efficacy point is the extent of change in serum levels of the estimated inflammatory cytokines in PO samples relative to the preoperative levels. The secondary endpoints include the total dose of IO fentanyl and PO morphine, PO pain scores, and surgeons' rating of the surgical conditions.
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 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women who will be admitted to undergo elective hysterectomy
- •,-ASA grade I or II,
- •Body mass index (BMI) of <35 kg/m2
排除标准
- •hemoglobin concentration of ≤7 gm%,
- •the presence of neuromuscular disorders
- •uncontrolled medical diseases
- •autoimmune diseases, maintenance on immunosuppressant therapy for any indication
- •refusal to sign the written consent
研究组 & 干预措施
MNMB
rocuronium will be given as 0.2 mg/kg to maintain a post-tetanic count (PTC) of >1, and TOF in the range of
干预措施: Moderate Neuromuscular Blockade (Drug)
DNMB
rocuronium infusion was used to provide 0.48-0.72 mg/kg/h to maintain PTC 0-1
干预措施: Deep neuromuscular block (Drug)
结局指标
主要结局
change in serum levels of the estimated inflammatory cytokines
时间窗: before induction of anesthesia and from the controls. Three PO samples (S2-4) will be obtained immediately at PACU admission, and 24 and 72 hours after surgery.
The frozen serum samples will be used to estimate serum biomarkers via a quantitative sandwich enzyme-linked immunosorbent assay (ELISA) technique, and the results will be read using a 96-well microplate ELISA reader (Dynatech MR 7000). The studied biomarkers include serum tumor necrosis factor-α (TNF-α), interleukin (IL)-1β, and IL-6.
次要结局
- total dose of IO fentanyl(Intraoperative period and first 24 hours postoperative)
- PO morphine(First 24 hours postoperative)
- Pain scores(Immediately after recovery,2 hours,4,hours ,6 hours ,12 hours,24 hours postoperative)
- Surgeons satisfaction(At the end of surgery)
研究者
rabab Mohammad habeeb
Principle investigator
Menoufia University