Validation of Subjective Rating Scales Used to Assess Surgical Conditions in Abdominal Surgery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Subjective rating scale
研究概览
简要总结
Use of neuromuscular blockade (NMB) may improve the surgical work space in patients scheduled for laparoscopic surgical cases (e.g. hysterectomy, ovarian cystectomy, myomectomy). Clinical studies investigating this question often use a numerical or verbal rating scale for subjective evaluation of the surgical workspace. However, no good subjective rating scale have been developed or validated. Neither have possible inter-individual differences in use of such subjective scales been described.
Purpose:
The aim of this study is to validate different subjective rating scales to determine which scale is most useful among surgeons.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •patients > 18 years old
- •elective gynecologic laparoscopic operation
- •can read and understand Danish
- •informed consent
排除标准
- •BMI > 30 kg/cm2
- •known allergy to medications that are included in the project
- •severe renal disease, defined by S-creatinine> 0,200 mmol/L, GFR < 30ml/min or hemodialysis)
- •neuromuscular disease that may interfere with neuromuscular data
- •lactating or pregnant
- •impaired liver function
- •converting to laparotomy
- •perioperative use of neuromuscular blocking agents before randomization
- •pneumoperitoneum set to >12 mmHg on the insufflator
研究组 & 干预措施
No NMB
Videorecordings and subjective ratings of intraabdominal surgical conditions during no neuromuscular blockade and during deep neuromuscular blockade.
干预措施: Rocuronium (Drug)
Deep NMB
Videorecordings and subjective ratings of intraabdominal surgical conditions during deep neuromuscular blockade and without neuromuscular blockade
干预措施: Rocuronium (Drug)
Deep NMB
Videorecordings and subjective ratings of intraabdominal surgical conditions during deep neuromuscular blockade and without neuromuscular blockade
干预措施: sugammadex (Drug)
Deep NMB
Videorecordings and subjective ratings of intraabdominal surgical conditions during deep neuromuscular blockade and without neuromuscular blockade
干预措施: placebo (Drug)
No NMB
Videorecordings and subjective ratings of intraabdominal surgical conditions during no neuromuscular blockade and during deep neuromuscular blockade.
干预措施: sugammadex (Drug)
No NMB
Videorecordings and subjective ratings of intraabdominal surgical conditions during no neuromuscular blockade and during deep neuromuscular blockade.
干预措施: placebo (Drug)
结局指标
主要结局
Subjective rating scale
时间窗: Evaluation of video images within a time frame of in average 5 months after surgery
The subjective rating scale with best possible interobserver agreement described by kappa statistics
次要结局
- Number of correct estimates of level of NMB(Evaluation of video images within a time frame of in average 5 months after surgery)
- Number of correct estimates of level of NMB according to grade of surgical experience(Evaluation of video images within a time frame of in average 5 months after surgery)