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The primary purpose of this study is to compare the remifentanil requirements in deep versus moderate neuromuscular blocks during the surgical pleth index -guided anesthesia in patients undergoing laparoscopic herniorrhaphy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Moderate NMB group | Placebo Comparator |
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| Deep NMB group | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Moderate neuromuscular block | Drug | maintaining of moderate neuromuscular block (train-of-four count 1-2) during surgery, reversal using neostigmine 50 ug/kg and glycopyrrolate 10 ug/kg |
| Measure | Description | Time Frame |
|---|---|---|
| Remifentanil Infusion Rate | remifentanil infusion using target effect-site concentration to achieve an surgical pleth index of range between 25 and 50 | from pneumoperitoneum to removal of laparoscope, an average of 30 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Anesthesiology and Pain Medicine, Ajou University School of Medicine | Suwon | Gyeonggido | South Korea |
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| ID | Title | Description |
|---|---|---|
| FG000 | Moderate NMB Group | Moderate neuromuscular block: maintaining of moderate neuromuscular block (train-of-four count 1-2) during surgery, reversal using neostigmine 50 ug/kg and glycopyrrolate 10 ug/kg |
| FG001 | Deep NMB Group |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 18, 2022 | Jan 20, 2022 |
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| Deep neuromuscular block | Drug | maintaining of deep neuromuscular block (posttetanic count 1-2) during surgery, reversal using sugammadex 4 mg/kg based on actual body weight |
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Deep neuromuscular block: maintaining of deep neuromuscular block (posttetanic count 1-2) during surgery, reversal using sugammadex 4 mg/kg based on actual body weight
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Moderate NMB Group | Moderate neuromuscular block: maintaining of moderate neuromuscular block (train-of-four count 1-2) during surgery, reversal using neostigmine 50 ug/kg and glycopyrrolate 10 ug/kg |
| BG001 | Deep NMB Group | Deep neuromuscular block: maintaining of deep neuromuscular block (posttetanic count 1-2) during surgery, reversal using sugammadex 4 mg/kg based on actual body weight |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Inter-Quartile Range | year |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 | Remifentanil Infusion Rate | remifentanil infusion using target effect-site concentration to achieve an surgical pleth index of range between 25 and 50 | Posted | Mean | Inter-Quartile Range | µg/kg/min | from pneumoperitoneum to removal of laparoscope, an average of 30 minutes |
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from the start of anesthesia induction until discharge of post-anesthesia care unit, an average of 130 minutes
Complications regarding deep NMB or sugammadex use
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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 NMB Group | Moderate neuromuscular block: maintaining of moderate neuromuscular block (train-of-four count 1-2) during surgery, reversal using neostigmine 50 ug/kg and glycopyrrolate 10 ug/kg | 0 | 67 | 0 | 67 | 0 | 67 |
| EG001 | Deep NMB Group | Deep neuromuscular block: maintaining of deep neuromuscular block (posttetanic count 1-2) during surgery, reversal using sugammadex 4 mg/kg based on actual body weight | 0 | 67 | 0 | 67 | 0 | 67 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Associate professor in Anesthesiology Department | Ajou University | 82-31-2195689 | beye98@aumc.ac.kr |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 18, 2022 | Jan 20, 2022 | SAP_001.pdf |
| ID | Term |
|---|---|
| D046449 | Hernia, Abdominal |
| ID | Term |
|---|---|
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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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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