The Effect of Deep Neuromuscular Blockade on Requirement of Intravenous Anesthetic Agent During Laparoscopic Colorectal Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 88
- 试验地点
- 2
- 主要终点
- Dosage of propofol
研究概览
简要总结
Recently, deep neuromuscular blockade during general anesthesia has been studied by many authors regarding various effects upon patients' outcomes and surgical conditions. We believe deep neuromuscular blockade can be especially beneficial in laparoscopic surgery, because it can expand surgical space and prevent patients' minute movements that can disturb precise operations. In clinical situations, anesthetists tend to compensate the insufficiency of neuromuscular blockade by increasing the dose of other anesthetic agents, which can prolong patients' recovery time and impair the surgical condition. In this study, we plan to divide the patients into 2 groups according to the depth of neuromuscular blockade, and compare the dose of anesthetic agent used to maintain surgical condition.
详细描述
Patients undergoing elective laparoscopic colorectal surgery are going to be recruited and divided into 2 groups: Group D will receive deep neuromuscular blockade, and Group M will receive moderate neuromuscular blockade using continuous infusion of rocuronium. Acceleromyography(TOF-watch SX) will be used to monitor the depth of blockade. In both groups, the anesthesia will be maintained with TIVA(total intra-venous anesthesia) including continuous target-controlled infusion of propofol and remifentanil. During the surgery, the number of patient movement and restoration of self respiration will be recorded. At the end of anesthesia, the dose of propofol and remifentanil used will be assessed and compared between the groups. Also, the satisfaction score of surgeons regarding the surgical condition, the anesthesia time, the operation time will be documented. After the patients are discharged, their charts are going to be reviewed and whether any pulmonary or surgical complications occurred will be documented.
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, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing elective laparoscopic colorectal resection due to benign or malignant neoplasm of colon or rectum
- •ASA class I or II
排除标准
- •Patients receiving medications known to have drug-drug interaction with neuromuscular blocking agents
- •Patients who have significantly impaired cardiac, pulmonary, hepatic, renal function
- •Patients who are pregnant
- •Patients who are known to have hypersensitivity to the anesthetic/analgesic/neuromuscular blocking agents which are going to be used in the study
- •BMI < 18.5 or > 35.0 kg/m2
- •Patients with previous history of open abdominal surgery
- •Patients with previous history of malignant hyperthermia
结局指标
主要结局
Dosage of propofol
时间窗: intraoperative (from starting of anesthesia to end of anesthesia)
the amount of propofol used (mg/kg)
次要结局
- Patient self respiration(intraoperative (from tracheal intubation to injection of neuromuscular reversal agent))
- Dosage of remifentanil(intraoperative (from starting of anesthesia to end of anesthesia))
- Patient movement(intraoperative (from tracheal intubation to injection of neuromuscular reversal agent))
- Surgical condition score(assessed at the end of the surgery)
研究者
BON WOOK KOO
Assistant professor
Seoul National University Bundang Hospital