Laparoscopy, Neuromuscular Blockade, Pneumoperitoneum, Rating Scales, Surgical Conditions
Conditions
Brief summary
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.
Interventions
DRUGRocuronium
DRUGsugammadex
DRUGplacebo
Sponsors
Herlev Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* patients \> 18 years old * elective gynecologic laparoscopic operation * can read and understand Danish * informed consent
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subjective rating scale | 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 |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
Denmark
Outcome results
None listed