The Effect of Neuromuscular Blockade During Transurethral Resection of Bladder Cancer on Surgical Condition and Recovery Profiles : A Prospective, Randomized and Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Number of Participants Attaining a 5 (Optimal) Surgical Condition Score
研究概览
简要总结
Transurethral resection of the bladder tumor (TURB) for bladder tumor excision is the mainstream treatment. However, the beneficial effects of sugammadex after general anesthesia for TURB have not been thoroughly evaluated. Investigators hypothesized that deep NMB and the use of sugammadex as a reversal agent may be associated with better endoscopic surgical condition and recovery profile compared with moderate NMB during TURB.
This study was designed to compare patients with deep neuromuscular blockade (NMB) with moderate NMB during transurethral resection of the bladder tumor (TURB) in terms of surgical condition and postoperative recovery.
详细描述
Transurethral resection of the bladder tumor (TURB) is the mainstream treatment of bladder cancer. TURB may be performed under regional anesthesia or general anesthesia. During regional anesthesia for TURB, obturator nerve block should be performed to prevent adductor contraction and possible inadvertent bladder perforation. Additionally, some patients prefer not to be conscious during the surgery and patients with spinal deformity or previous spinal fusion surgery are prone to fail regional anesthesia. Therefore, general anesthesia with neuromuscular blockade (NMB) is frequently conducted for patients with TURB.
During general anesthesia for TURB, NMB is needed for intubation and optimal endoscopic surgical condition via obturator nerve block. TURB is a relatively short procedure but patients with NMB usually need sufficient time to be reversed with the conventional NMB reversal agents (anticholinesterases). Additionally, inadequate reversal from NMB may result in respiratory complication during recovery. Sugammadex, a newer reversal agent, is a selective relaxant-binding agent that allows for rapid reversal of rocuronium-induced NMB. With the introduction of sugammadex, immediate reversal of deep NMB has become possible without residual NMB.
Several previous studies evaluated the effect of NMB on surgical condition for relative short surgeries such as laparoscopic cholecystectomy or laryngeal micro-surgery. They suggested that deep NMB and reversal with sugammadex improved surgical condition without postop respiratory complications. TURB is a urological endoscopic procedure performed in a narrow bladder space but the beneficial effects of deep NMB with sugammadex reversal for TURB have not been thoroughly evaluated. We hypothesized that deep NMB and the use of sugammadex as a reversal agent may be associated with better endoscopic surgical condition compared with moderate NMB during TURB. Therefore, this study was designed to compare deep NMB with moderate NMB during TURB in terms of surgical condition and recovery profiles in patients with general anesthesia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged more than 18 years
- •American Society of Anesthesiologists (ASA) physical status I and II
- •scheduled to undergo elective Transurethral resection of the bladder tumor (TURB)
排除标准
- •history of neuromuscular, renal, or hepatic disease
- •a body mass index (BMI) of < 18.5 or > C 30.0 kg/m2
- •treatment with drugs known to interfere with neuromuscular function
研究组 & 干预措施
moderate neuromuscular blockade
During operation, intravenous rocuronium was used to maintain moderate (TOF count of 1 or 2). Patients in moderate neuromuscular blockade are reversed with 2 mg/kg sugammadex at a TOF count of 1 or 2.
干预措施: Rocuronium (Drug)
moderate neuromuscular blockade
During operation, intravenous rocuronium was used to maintain moderate (TOF count of 1 or 2). Patients in moderate neuromuscular blockade are reversed with 2 mg/kg sugammadex at a TOF count of 1 or 2.
干预措施: Sugammadex (Drug)
deep neuromuscular blockade
During operation, intravenous rocuronium was used to maintain deep (TOF count of 0 with post-tetanic count of 2) neuromuscular blockade. Patients in the deep neuromuscular blockade are reversed with 4 mg/kg sugammadex at post-tetanic count of 2.
干预措施: Rocuronium (Drug)
deep neuromuscular blockade
During operation, intravenous rocuronium was used to maintain deep (TOF count of 0 with post-tetanic count of 2) neuromuscular blockade. Patients in the deep neuromuscular blockade are reversed with 4 mg/kg sugammadex at post-tetanic count of 2.
干预措施: Sugammadex (Drug)
结局指标
主要结局
Number of Participants Attaining a 5 (Optimal) Surgical Condition Score
时间窗: immediately following the operation, an average of 5 minutes
5-point surgical condition scale was evaluated as follows. 1. Extremely poor * unable to work because of coughing or because of the inability to obtain a endoscopic view because of inadequate muscle relaxation. Additional neuromuscular blocking agents (NMB) must be given. 2. Poor * severely hampered by inadequate muscle relaxation with continuous muscle contractions, movements, or both with the hazard of tissue damage. Additional NMB is needed. 3. Acceptable * a wide endoscopic view but bladder contractions, movements, or both occur regularly causing some interference with the surgeon's work. There is the need for additional NMB to prevent deterioration. 4. Good * a wide endoscopic working field with sporadic muscle contractions, movements, or both. No immediate need for additional NMB unless there is the fear of deterioration. 5. Optimal * a wide endoscopic working field without any movement or contractions. No additional NMB is needed.
次要结局
- the Incidence of Desaturation(During PACU stay (An average of 15 minutes))
- Other Postoperative Adverse Events(During PACU stay (An average of 15 minutes))
- Incidence of Postoperative Residual Curarization(at the arrival of postoperative post-anesthesia care unit (PACU), an average of 5 minutes)
- Recovery Time (PACU Discharge)(During PACU stay (An average of 15 minutes))
研究者
Junghee Ryu
Associate professor
Seoul National University Bundang Hospital