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Intraocular pressure is significantly increase during robot-assisted laparoscopic radical prostatectomy which is performed in a steep trendelenburg position at prolonged times of pneumoperitoneum. Therefore investigators decided to evaluate the impacts of surgical visibility through deep neuromuscular blockade on intraocular pressure in patients undergoing Robot-Assisted Laparoscopic Radical Prostatectomy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Deep neuromuscular blockade | Experimental | Deep neuromuscular blockade |
|
| moderate neuromuscular blockade | Active Comparator | moderate neuromuscular blockade |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| deep neuromuscular blockade | Procedure | deep neuromuscular blockade using rocuronium and reverse with sugammadex |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Intraocular Pressure During RALRP Under Deep Neuromuscular Blockade | maximum intraocular pressure during RALRP under deep neuromuscular blockade after being positioned in the steep Trendelenburg position with CO2 pneumoperitoneum under deep neuromuscular blockade | Maximum intraocular pressure was measured at 60 minutes after CO2 pneumoperitoneum in the ST position |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Surgical Condition | overall surgical conditions using the 5-point rating scale as previously described: Grade 5 (optimal), optimal surgical conditions; grade 4 (good), nonoptimal conditions, but an intervention is not required; grade 3 (acceptable), wide surgical view, but an intervention can improve surgical conditions, grade 2 (poor), inadequate conditions, there is a visible view, but an intervention is necessary to ensure acceptable surgical conditions; grade 1 (extremely poor), inability to perform surgery; therefore, intervention is necessary. |
| Measure | Description | Time Frame |
|---|---|---|
| Post-operative Nausea | During 24hours after operation | |
| Incidence of Residual Neuromuscular Blockade | During 24hours after operation |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine | Seoul | Seoul | 120-752 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26317357 | Derived | Yoo YC, Kim NY, Shin S, Choi YD, Hong JH, Kim CY, Park H, Bai SJ. The Intraocular Pressure under Deep versus Moderate Neuromuscular Blockade during Low-Pressure Robot Assisted Laparoscopic Radical Prostatectomy in a Randomized Trial. PLoS One. 2015 Aug 28;10(8):e0135412. doi: 10.1371/journal.pone.0135412. eCollection 2015. |
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No test entered
Subjects were screened and enrolled at 1 site in the Korea
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| ID | Title | Description |
|---|---|---|
| FG000 | Moderate Neuromuscular Blockade (Moderate NMB Group) | Moderate NMB Group included patients who received an IV atracurium bolus (0.5 mg kg-1) following the continuous infusion of 0.3 mg kg-1 until the end of the ST position. Dose titration was assigned to an attending anaesthetist via regulation of the bolus infusion speed to maintain a TOF count of 1 to 2. Neostigmine was used to reverse the effects of NMB after surgery. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| moderate neuromuscular blockade | Procedure | moderate neuromuscular blockade using atracurium and reverse with neostigmine |
|
| Rocuronium | Drug |
|
| Sugammadex | Drug |
|
| Atracurium | Drug |
|
| Neostigmine | Drug |
|
| At the end of the Steep trendelenburg position, an average of 1 hour |
| FG001 | Deep Neuromuscular Blockade (Deep NMB Group) | Deep NMB Group included patients who received an intravenous (IV) rocuronium bolus (1.0 mg kg-1) following the continuous infusion of 0.6 mg kg-1 until the end of the ST position. Dose titration was assigned to an attending anaesthetist via regulation of the bolus infusion speed to maintain a post-tetanic count (PTC) of 1 to 2. Sugammadex was administered to reverse the effects of NMB after surgery. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Moderate Neuromuscular Blockade | moderate neuromuscular blockade: moderate neuromuscular blockade using atracurium and reverse with neostigmine Atracurium Neostigmine |
| BG001 | Deep Neuromuscular Blockade | deep neuromuscular blockade: deep neuromuscular blockade using rocuronium and reverse with sugammadex Rocuronium Sugammadex |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| 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 | Maximum Intraocular Pressure During RALRP Under Deep Neuromuscular Blockade | maximum intraocular pressure during RALRP under deep neuromuscular blockade after being positioned in the steep Trendelenburg position with CO2 pneumoperitoneum under deep neuromuscular blockade | Posted | Mean | Standard Deviation | mmHg | Maximum intraocular pressure was measured at 60 minutes after CO2 pneumoperitoneum in the ST position |
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| Secondary | Overall Surgical Condition | overall surgical conditions using the 5-point rating scale as previously described: Grade 5 (optimal), optimal surgical conditions; grade 4 (good), nonoptimal conditions, but an intervention is not required; grade 3 (acceptable), wide surgical view, but an intervention can improve surgical conditions, grade 2 (poor), inadequate conditions, there is a visible view, but an intervention is necessary to ensure acceptable surgical conditions; grade 1 (extremely poor), inability to perform surgery; therefore, intervention is necessary. | Posted | Median | Inter-Quartile Range | units on a scale | At the end of the Steep trendelenburg position, an average of 1 hour |
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| Other Pre-specified | Post-operative Nausea | Posted | Number | events | During 24hours after operation |
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| Other Pre-specified | Incidence of Residual Neuromuscular Blockade | Posted | Number | participants | During 24hours after operation |
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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 Blockade | moderate neuromuscular blockade: moderate neuromuscular blockade using atracurium and reverse with neostigmine Atracurium Neostigmine | 0 | 33 | 0 | 33 | ||
| EG001 | Deep Neuromuscular Blockade | deep neuromuscular blockade: deep neuromuscular blockade using rocuronium and reverse with sugammadex Rocuronium Sugammadex | 0 | 33 | 0 | 34 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Sun-Jun, Bae | Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine,Severance Hospital, Yonsei University Health System | +82-02-2228-4438 | SJBAI1@yuhs.ac |
| ID | Term |
|---|---|
| D000077123 | Rocuronium |
| D000077122 | Sugammadex |
| D001279 | Atracurium |
| D009388 | Neostigmine |
| ID | Term |
|---|---|
| D000732 | Androstanols |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D047408 | gamma-Cyclodextrins |
| D003505 | Cyclodextrins |
| D047028 | Macrocyclic Compounds |
| D003912 | Dextrins |
| D013213 | Starch |
| D005936 | Glucans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D044182 | Benzylisoquinolines |
| D007546 | Isoquinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D050338 | Phenylammonium Compounds |
| D000644 | Quaternary Ammonium Compounds |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D009861 | Onium Compounds |
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| >=65 years |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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