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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
| Medical Center Haaglanden | OTHER |
This is a randomized control trial (RCT) that studies the surgical conditions during moderate and deep neuromuscular blockade in 100 morbidly obese patients receiving elective laparoscopic surgery for bariatric surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| moderate neuromuscular block | Active Comparator | rocuronium 0.1-0.6 mg/kg aimed at a train of four of 1 - 2 twitches |
|
| deep neuromuscular block | Experimental | rocuronium 0.1-0.6 mg/kg aimed at a post tetanic count of 1 - 2 twitches |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rocuronium | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Surgical Rating | During a procedure, the surgical condition will be scored by one surgeon using a 5-point surgical rating. This will be done at 10 min intervals from the start of surgery until the end of surgery scale. The rating scale is a 5-point ordinal scale ranging from 1 = poor condition to 5 = optimal surgical conditions. The mean difference in ratings between procedures under deep neuromuscular block and those during moderate neuromuscular block will be evaluated. The rating scale will be averaged for each subject and the mean values will be reported. | intraoperative |
| Measure | Description | Time Frame |
|---|---|---|
| Extubation | The investigators will assess the time from the injection of the reversal agent until the time to removal of the endotracheal tune (extubation). | intraoperative |
| Pain | pain will be scored using numeric rating scale (0-10, with 0 = no pain and 10 = most pain imaginable), at 10 minute intervals at the post anesthesia care unit, but only the mean value will be used in the analysis and reported. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Albert Dahan, MD, PhD, professor | LUMC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Leiden University Medical Center | Leiden | South Holland | Netherlands | |||
| Medisch Centrum Haaglanden / Nederlandse Obesitas Kliniek |
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| ID | Title | Description |
|---|---|---|
| FG000 | Moderate Neuromuscular Block | rocuronium 0.1-0.6 mg/kg aimed at a train of four of 1 - 2 twitches Rocuronium |
| FG001 | Deep Neuromuscular Block | rocuronium 0.1-0.6 mg/kg aimed at a post tetanic count of 1 - 2 twitches Rocuronium |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Moderate Neuromuscular Block | rocuronium 0.1-0.6 mg/kg aimed at a train of four of 1 - 2 twitches Rocuronium |
| BG001 | Deep Neuromuscular Block | rocuronium 0.1-0.6 mg/kg aimed at a post tetanic count of 1 - 2 twitches Rocuronium |
| 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 | Surgical Rating | During a procedure, the surgical condition will be scored by one surgeon using a 5-point surgical rating. This will be done at 10 min intervals from the start of surgery until the end of surgery scale. The rating scale is a 5-point ordinal scale ranging from 1 = poor condition to 5 = optimal surgical conditions. The mean difference in ratings between procedures under deep neuromuscular block and those during moderate neuromuscular block will be evaluated. The rating scale will be averaged for each subject and the mean values will be reported. | Posted | Mean | Standard Deviation | units on a scale | intraoperative |
|
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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 | Moderate Neuromuscular Block | rocuronium 0.1-0.6 mg/kg aimed at a train of four of 1 - 2 twitches Rocuronium |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof. Dr. A. Dahan | Leiden University Medical Center | +31 71 526 2301 | a.dahan@lumc.nl |
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| ID | Term |
|---|---|
| D000077123 | Rocuronium |
| ID | Term |
|---|---|
| D000732 | Androstanols |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| postoperative, for up to 2 hours |
| Respiration | Respiration will be measured by counting the respiratory rate at 10 min interval for 2 hours in the post anesthesia care unit. The breaths per min (unit 1/min) will be logged. The data were averaged per subject and the mean of the mean data are reported. | 2 hours postoperative |
| Mean Arterial Blood Pressure | Mean arterial pressure (MAP in mmHg) will be monitored at 10 minute intervals for 2 hours in the post anesthesia care unit. The data will be averaged per subject and the mean of the mean values are reported. | 2 hours postoperative |
| The Hague |
| South Holland |
| Netherlands |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Gender | Count of Participants | Participants |
|
rocuronium 0.1-0.6 mg/kg aimed at a post tetanic count of 1 - 2 twitches Rocuronium |
|
|
|
| Secondary | Extubation | The investigators will assess the time from the injection of the reversal agent until the time to removal of the endotracheal tune (extubation). | Posted | Mean | Inter-Quartile Range | minutes | intraoperative |
|
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|
|
| Secondary | Pain | pain will be scored using numeric rating scale (0-10, with 0 = no pain and 10 = most pain imaginable), at 10 minute intervals at the post anesthesia care unit, but only the mean value will be used in the analysis and reported. | Posted | Mean | Standard Deviation | units on a scale | postoperative, for up to 2 hours |
|
|
|
|
| Secondary | Respiration | Respiration will be measured by counting the respiratory rate at 10 min interval for 2 hours in the post anesthesia care unit. The breaths per min (unit 1/min) will be logged. The data were averaged per subject and the mean of the mean data are reported. | Posted | Mean | Standard Deviation | breaths per minute | 2 hours postoperative |
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| Secondary | Mean Arterial Blood Pressure | Mean arterial pressure (MAP in mmHg) will be monitored at 10 minute intervals for 2 hours in the post anesthesia care unit. The data will be averaged per subject and the mean of the mean values are reported. | Posted | Mean | Standard Deviation | millimeters of mercury | 2 hours postoperative |
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|
|
| 0 |
| 50 |
| 0 |
| 50 |
| EG001 | Deep Neuromuscular Block | rocuronium 0.1-0.6 mg/kg aimed at a post tetanic count of 1 - 2 twitches Rocuronium | 0 | 50 | 0 | 50 |
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| D011083 |
| Polycyclic Compounds |