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| ID | Type | Description | Link |
|---|---|---|---|
| NL34186.058.10 | Other Identifier | LUMC |
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Suboptimal reversal of neuromuscular blockage after surgery is possibly related to unfavorable postoperative respiratory conditions and elevated pain levels. Rapid and complete reversal of neuromuscular block was not possible untill sugammadex was discovered. The investigators hyposthesise that reversal with sugammadex leads to favorable postoperative respiratory conditions and less pain compared to reversal with neostigmine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sugammadex | Experimental | Subjects in this arm will be reversed with sugammadex 2-4 mg/kg |
|
| neostigmine | Active Comparator | subjects in this arm will be reversed with neostigmine 1.0-2.5 mg and atropine 0.5-1.0mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sugammadex | Drug |
|
| |
| Neostigmine |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Lowest Saturation | Mean saturation is the mean value of the beat-to-beat Hb-oxygen saturation measured by finger pulse oximeter as measured in the first 45 min in the recovery room following surgery | 45 minutes post surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Pain | using the 1-10 numeric rating scale | 45 minutes post surgery |
| Sedation | using the Leiden observer alertness score (1 alert - 5 sedated) |
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Inclusion Criteria:
Age 18 years
- BMI < 35
-ASA class I- III
-Patients scheduled for surgery requiring general anesthesia with the use of NMBA's
Exclusion Criteria:
Failure to meet the inclusion criteria
A (family) history of malignant hyperthermia
Intestinal obstruction,
COPD GOLD 4
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| Name | Affiliation | Role |
|---|---|---|
| Albert Dahan, MD, PhD, Professor | Leiden Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Leiden Medical University | Leiden | South Holland | 2333ZA | Netherlands |
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| ID | Title | Description |
|---|---|---|
| FG000 | Sugammadex | Subjects in this arm will be reversed with sugammadex 2-4 mg/kg Sugammadex |
| FG001 | Neostigmine | subjects in this arm will be reversed with neostigmine 1.0-2.5 mg and atropine 0.5-1.0mg Neostigmine |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Sugammadex | Subjects in this arm will be reversed with sugammadex 2-4 mg/kg Sugammadex |
| BG001 | Neostigmine | subjects in this arm will be reversed with neostigmine 1.0-2.5 mg and atropine 0.5-1.0mg Neostigmine |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Lowest Saturation | Mean saturation is the mean value of the beat-to-beat Hb-oxygen saturation measured by finger pulse oximeter as measured in the first 45 min in the recovery room following surgery | Posted | Mean | 95% Confidence Interval | percentage of oxygen saturation | 45 minutes post surgery |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sugammadex | Subjects in this arm will be reversed with sugammadex 2-4 mg/kg Sugammadex |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof Dr A. Dahan | LUMC | +31 71 526 2301 | a.dahan@lumc.nl |
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| ID | Term |
|---|---|
| D012131 | Respiratory Insufficiency |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D000077122 | Sugammadex |
| D009388 | Neostigmine |
| ID | Term |
|---|---|
| D047408 | gamma-Cyclodextrins |
| D003505 | Cyclodextrins |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
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| Drug |
|
|
| 45 minutes post surgery |
| BG002 | Total | Total of all reporting groups |
| years of age |
|
| Gender | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Pain | using the 1-10 numeric rating scale | Posted | Mean | 95% Confidence Interval | Numeric rating scale. 1(low)-10(maximum) | 45 minutes post surgery |
|
|
|
| Secondary | Sedation | using the Leiden observer alertness score (1 alert - 5 sedated) | Posted | Mean | 95% Confidence Interval | sedation scale (1 alert - 5 sedated) | 45 minutes post surgery |
|
|
|
| 0 |
| 50 |
| 0 |
| 50 |
| EG001 | Neostigmine | subjects in this arm will be reversed with neostigmine 1.0-2.5 mg and atropine 0.5-1.0mg Neostigmine | 0 | 50 | 0 | 50 |
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| D003912 |
| Dextrins |
| D013213 | Starch |
| D005936 | Glucans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D050338 | Phenylammonium Compounds |
| D000644 | Quaternary Ammonium Compounds |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D009861 | Onium Compounds |