Validation of Subjective Rating Scales Used to Assess Surgical Conditions in Abdominal Surgery

Study Overview
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Brief Summary
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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.

Official Title
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Validation of Subjective Rating Scales Used to Assess Surgical Conditions in Abdominal Surgery

Conditions
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Surgical Conditions, Rating Scales, Laparoscopy, Neuromuscular Blockade, Pneumoperitoneum

Intervention / Treatment
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* Drug: Rocuronium
* Drug: sugammadex
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Deep NMB<br>Videorecordings and subjective ratings of intraabdominal surgical conditions during deep neuromuscular blockade and without neuromuscular blockade | Drug: Rocuronium<br> <br> Drug: sugammadex<br> <br> Drug: placebo<br> <br> |
| Placebo Comparator: No NMB<br>Videorecordings and subjective ratings of intraabdominal surgical conditions during no neuromuscular blockade and during deep neuromuscular blockade. | Drug: Rocuronium<br> <br> Drug: sugammadex<br> <br> Drug: placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective rating scale | The subjective rating scale with best possible interobserver agreement described by kappa statistics | Evaluation of video images within a time frame of in average 5 months after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 |