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临床试验/NCT04371588
NCT04371588已完成不适用

Effect of Perioperative Muscle Relaxant Model on Postoperative Outcomes in Chinese Patients

Air Force Military Medical University, China9 个研究点 分布在 1 个国家目标入组 999 人开始时间: 2018年3月17日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
999
试验地点
9
主要终点
Visual Analogue Scale of pain at rest at 24 hours after surgery

研究概览

简要总结

Muscle relaxant is usually needed for surgery. However, the optimal depth of neuro-muscular blockade is still on debate. Deep neuro-muscular blockade may benefit the patients during surgery, but may increase the risk of residual blockade after surgery. Residual blockade has been reported to increase risk of morbidity. In this study, we tend to observe the postoperative outcomes in patients undergoing abdominal surgery under general anesthesia. And to compare the outcomes in patients received different depth of neuro-muscular blockade.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥18 years old
  • Body mass <18 kg/m2
  • American Society of Anesthesiologists status I-II
  • Patients scheduled for elective laparoscopic colorectal or urological surgery
  • Patients received general anesthesia and muscle relaxant
  • Patients with written informed consent.

排除标准

  • Second surgery during the same admission.
  • Outpatient surgery
  • Retroperitoneal laparoscopic surgery
  • Patients scheduled for mechanical ventilation after surgery
  • Patients scheduled for muscle relaxant other than rocuronium
  • Patients with pregnancy or planned for breeding
  • Patients who are involved in other studies

结局指标

主要结局

Visual Analogue Scale of pain at rest at 24 hours after surgery

时间窗: from end of surgery to 24 hours after surgery

The intensity of pain is reported by the patient by provide a number between 0 and 10. 0 means no pain, and 10 means unbearable pain. Higher score means stronger pain.

Visual Analogue Scale of pain at cough at 24 hours after surgery

时间窗: from end of surgery to 24 hours after surgery

The intensity of pain is reported by the patient by provide a number between 0 and 10. 0 means no pain, and 10 means unbearable pain. Higher score means stronger pain.

次要结局

  • Time to flatus(from end of surgery to flatus, on an average of 3 days)
  • Time to extubation of the endotracheal tube(from end of surgery to removal of the endotracheal tube, on an average of 15 minutes)
  • Incidence of patients suffering pain at 24 hours after surgery(from end of surgery to 24 hours after surgery)
  • Incidence of major postoperative complications(from end of surgery to discharge from the hospital, on an average of 5 days)
  • Satisfaction score of the Surgeon to the condition during surgery(from start of surgery to end of surgery, on an average of 2.5 hours)

研究者

发起方
Air Force Military Medical University, China
申办方类型
Other
责任方
Principal Investigator
主要研究者

Zhihong LU

Professor

Air Force Military Medical University, China

研究点 (9)

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