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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-001164-29 | EudraCT Number |
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To investigate if deep neuromuscular blockade improves intraabdominal volume compared to no neuromuscular blockade in patients scheduled for gynecologic laparoscopic surgery with pneumoperitoneum 12 mmHg.
Hypothesis:
Deep neuromuscular blockade improves intraabdominal space (the distance from promontorium to skin surface, cm) compared to no neuromuscular blockade.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Deep neuromuscular block followed by no neuromuscular block | Active Comparator | Deep neuromuscular blockade (PTC 0-1) with rocuronium 1 mg/kg followed by no neuromuscular blockade with sugammadex 8 mg/kg and placebo reversal. Measurements of intraabdominal distance during deep neuromuscular blockade and without neuromuscular blockade |
|
| No neuromuscular block followed by deep neuromuscular block | Placebo Comparator | No neuromuscular blockade with placebo followed by deep neuromuscular blockade (PTC 0-1) with rocuronium 1 mg/kg and reversal with sugammadex 8 mg/kg. Measurements of intraabdominal distance during no neuromuscular blockade and during deep neuromuscular blockade. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rocuronium | Drug |
| ||
| Measure | Description | Time Frame |
|---|---|---|
| Intraabdominal Distance (Centimeters) | Difference in intraabdominal distance from promontorium to the edge of the trocar in umbilicus at 12 mmHg with and without deep neuromuscular blockade (PTC 0-1). | 1 hour |
| Measure | Description | Time Frame |
|---|---|---|
| Intraabdominal Distance (Centimeters) | Difference in intraabdominal distance from promontorium to the edge of the trocar in umbilicus at 8 mmHg with and without deep neuromuscular blockade (PTC 0-1). | 1 hour |
| Surgical Conditions During Suturing of the Abdominal Fascia |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Matias Vested Madsen, MD | Department of Anesthesiology Herlev Hospital | Principal Investigator |
| Olav Istre, MD, DMSc, professor | Department of minimal invasive gynecology, Aleris-Hamlet, Copenhagen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of minimal invasive gynecology Aleris-Hamlet Private Hospital | Copenhagen | Søborg | 2830 | Denmark |
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Carried out between November 2013 and April 2014. Center for Minimal Invasive Gynaecology, Aleris-Hamlet Hospital Copenhagen, Denmark.
A total of 25 patients were eligible in the study period, of which nine declined to participate, and two were excluded due to the fact that they did not speak Danish. All 14 patients completed the study
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| ID | Title | Description |
|---|---|---|
| FG000 | Deep Neuromuscular Block First Then no Neuromuscular Block | Deep neuromuscular blockade (PTC 0-1) with rocuronium 1 mg/kg followed by no neuromuscular blockade with sugammadex 8 mg/kg and placebo reversal. Measurements of intraabdominal distance during deep neuromuscular blockade and without neuromuscular blockade rocuronium sugammadex placebo |
| FG001 | No Neuromuscular Block First Then Deep Neuromuscular Block | No neuromuscular blockade with placebo followed by deep neuromuscular blockade (PTC 0-1) with rocuronium 1 mg/kg and reversal with sugammadex 8 mg/kg. Measurements of intraabdominal distance during no neuromuscular blockade and during deep neuromuscular blockade. rocuronium sugammadex placebo |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Females
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| ID | Title | Description |
|---|---|---|
| BG000 | Patient Characteristics in 14 Women |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Intraabdominal Distance (Centimeters) | Difference in intraabdominal distance from promontorium to the edge of the trocar in umbilicus at 12 mmHg with and without deep neuromuscular blockade (PTC 0-1). | Comparisons of changes in distances were performed with paired t-test. | Posted | Median | Full Range | centimeters | 1 hour |
|
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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 | Deep Neuromuscular Block First Then no Neuromuscular Block | Difference in intraabdominal distance comparing deep neuromuscular blockade (PTC 0-1) with no neuromuscular blockade. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Matias Vested Madsen | Herlev Hospital, University of Copenhagen, Department of Anesthesiology | +4538689058 | matias.vested.madsen@regionh.dk |
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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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| sugammadex |
| Drug |
|
| placebo | Drug |
|
Optimal (score 1) Good (score 2) Acceptable (score 3) Poor (score 4) |
| 1 hour |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| BMI | Mean | Standard Deviation | kg/m2 |
|
| Number of patients with previous abdominal surgery | Number | participants |
|
| Number of patients with 0 pregnancies | Number | participants |
|
| Number of patients with 1 pregnancy | Number | participants |
|
| Number of patients with 2 pregnancies | Number | participants |
|
| Number of patients with 3 pregnancies | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Secondary | Intraabdominal Distance (Centimeters) | Difference in intraabdominal distance from promontorium to the edge of the trocar in umbilicus at 8 mmHg with and without deep neuromuscular blockade (PTC 0-1). | Comparisons of changes in distances were performed with paired t-test | Posted | Median | 95% Confidence Interval | centimeters | 1 hour |
|
|
|
|
| Secondary | Surgical Conditions During Suturing of the Abdominal Fascia | Optimal (score 1) Good (score 2) Acceptable (score 3) Poor (score 4) | Evaluation of surgical conditions was compared using Mann-Whitney U-test. | Posted | Number | participants | 1 hour |
|
|
|
| 0 |
| 7 |
| 0 |
| 7 |
| EG001 | No Neuromuscular Block First Then Deep Neuromuscular Block | Difference in intraabdominal distance comparing deep neuromuscular blockade (PTC 0-1) with no neuromuscular blockade. | 0 | 7 | 0 | 7 |
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| D011083 |
| Polycyclic Compounds |
| D047408 | gamma-Cyclodextrins |
| D003505 | Cyclodextrins |
| D047028 | Macrocyclic Compounds |
| D003912 | Dextrins |
| D013213 | Starch |
| D005936 | Glucans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| Acceptable (score 3) |
|
| Poor (score 4) |
|