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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Deep NMB | Active Comparator | Videorecordings and subjective ratings of intraabdominal surgical conditions during deep neuromuscular blockade and without neuromuscular blockade |
|
| No NMB | Placebo Comparator | Videorecordings and subjective ratings of intraabdominal surgical conditions during no neuromuscular blockade and during deep neuromuscular blockade. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rocuronium | Drug |
| ||
| sugammadex |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Matias V Madsen, MD | Herlev Hospital Department of Anethesiology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of minimal invasive gynecology Aleris-Hamlet Private Hospital | Søborg | 2860 | Denmark |
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| ID | Term |
|---|---|
| D011027 | Pneumoperitoneum |
| ID | Term |
|---|---|
| D010532 | Peritoneal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D000077123 | Rocuronium |
| D000077122 | Sugammadex |
| ID | Term |
|---|---|
| D000732 | Androstanols |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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|
| placebo | Drug |
|
| D011083 |
| Polycyclic Compounds |
| D047408 | gamma-Cyclodextrins |
| D003505 | Cyclodextrins |
| D047028 | Macrocyclic Compounds |
| D003912 | Dextrins |
| D013213 | Starch |
| D005936 | Glucans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |