Recovery From Deep Neuromuscular Blockade Using Different Sugammadex Doses in Elderly Patients Undergoing Laparoscopic Robot-assisted Prostatectomy: a Prospective, Randomized, Double-blind Clinical Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Neuromuscular recovery time
研究概览
简要总结
The aim of this prospecive randomized study is to evaluate the effects of a dose of sugammadex increased by 50% compared to a standard dose on recovery time from deep neuromuscular block in elderly patients undergoing robot-assisted laparoscopic radical prostatectomy (RALP). Secondary objectives are to evaluate the different extubation time, time to exit from the operating room (OR), lenght of stay in post-anaesthesia care unit (PACU) and safety (hemodynamic parameters and respiratory function).
详细描述
An increasing percentage of elderly patients with localized prostate cancer undergo RALP, due to the higher safety and feasibility of this minimally invasive surgical option compared to standard open procedure. This procedure is performed under deep neuromuscular block (dNMB) in order to guarantee an adequate working space. Induction and maintenance of the dNMB require neuromuscular monitoring and adequate reversal at the end of the intervention to prevent postoperative residual curarization (PORC). Sugammadex is the most attractive strategy to titrate reversal according to NMB monitoring data and to ensure a complete recovery of muscle function before extubation. In elderly patients, the risk of PORC and related postoperative complications is higher. For these reasons, we hypothesize that a dose of sugammadex increased by 50% compared to a standard dose could significantly shorten neuromuscular recovery time, extubation time, OR discharge time and PACU length of stay in elderly patients undergoing RALP.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The patient as well as the investigator (care provider) who will administer the different blinded sugammadex dosage and collect postoperative data will be blinded to the group allocation. The randomization and preparation of the drug will be performed by the unblinded staff of hospital experimental pharmacy who will carry out the randomization with a 1: 1 ratio and will assign the different dose to each patient. The drug will be prepared in a shielded pre-filled syringe in order to maintain blindness. In case of emergency, the pharmacy staff will immediately open the randomization code of interest disclosing the group assignment (sugammadex dose).
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •patient's age ≥65years
- •prostate cancer
- •robot-assisted laparoscopic radical prostatectomy (RALP)
排除标准
- •inability to obtain written informed consent
- •history of significant liver, renal or pulmonary diseases
- •current smoking
- •chronic or acute alcoholism
- •known or suspected neuromuscular disorders
- •family history of malignant hyperthermia
- •any pre-existing coagulopathy
- •abnormal blood coagulation tests (including prothrombin time <70%; activated partial thromboplastin time >38 seconds and INR >1.20) or preoperative anticoagulant therapies
- •BMI ≥30 Kg/m2
- •known allergy or hypersensitivity to the drugs used in the study
- •planned postoperative admission to intensive care unit.
- •moderate neuromuscular block (TOF 1-3) at the end of surgery
研究组 & 干预措施
Increased dose of sugammadex
A dose of 6 mg/kg of sugammadex will be given intravenously for deep neuromuscular block reversal at the end of surgery
干预措施: Sugammadex 6 mg/kg (Drug)
Standard dose of sugammadex
A dose of 6 mg/kg of sugammadex will be given intravenously for deep neuromuscular block reversal at the end of surgery
干预措施: Sugammadex 4 mg/kg (Drug)
结局指标
主要结局
Neuromuscular recovery time
时间窗: 5 minutes
Time from the end of sugammadex administration to train-of-four (TOF)=1
次要结局
- Hemodynamic parameters(up to discharge from post-anaesthesia care unit, an average of 2 hours)
- Respiratory function(up to discarge from post-anaesthesia care unit, an average of 2 hours)
- Time to extubation(10 minutes)
- PACU length of stay(2 hours)
- Time to OR exit(30 minutes)