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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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It is unknown the impact of deep neuromuscular paralysis and using a novel agent, sugammadex as an reversal in endolaryngeal surgery.
We will conduct a clinical study aiming to compare two treatment strategies; Deep neuromuscular Blockade and moderate Neuromuscular Blockade. We hypothesize that deep NMB will offer better stillness. We will also descriptively examine if patients would be safely discharged from a recovery room.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Deep Neuromuscular Blockade arm | Experimental | After initial doses of 0.6 mg Rocuronium, a continuous infusion can be initiated to maintain 0 responses to train-of-four (TOF) stimulation or 1-2 responses to Post-Tetanic Count (PTC) (Deep NMB). The pump rate will vary and depends on the PTC value. The initial pump rate will be set at 0.5 mg/kg per hour. In case of a deviation from the required PTC value the pump rate can be increased or decreased. This was left to the discretion of the attending anaesthetist. Deep NMB should be maintained throughout the operation. The infusion of Rocuronium will be discontinued and Sugammadex will be given 4 mg/kg at the end of surgery, which is from deep NMB (PTC = 1-2). |
|
| Moderate Neuromuscular Blockade arm | Active Comparator | After evidence of early spontaneous recovery (< 10% of control T1) from initial doses of 0.6 mg rocuronium, a continuous infusion can be initiated to maintain 1 to 2 responses to train-of-four stimulation (Moderate NMB). The initial pump rate will be set at 0.5 mg/kg per hour. In case of a deviation from the required TOF value the pump rate can be increased or decreased. This was left to the discretion of the attending anaesthesiologist. Moderate paralysis should be maintained throughout an operation. At the end of surgery, the infusion of Rocuronium will be discontinued and Sugammadex 2 mg/kg via bolus injections]will be administered at least reappearance of T2. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Deep Neuromuscular Blockade | Procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Patients Who Have a Clinically Acceptable Surgical Conditions | Proportion of patients who have a excellent and good surgical condition score | intraoperative |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Modified Aldrete's Score ≥ 9 | Time from Post Anesthesia Care Unit (PACU) arrival to patients were considered fit for discharge from the PACU by Modified Aldrete's score assessment which scale range is from 0-10. Higher value represents a better outcome. | Minutes from Post Anesthesia Care Unit (PACU) arrival to patients were considered fit for discharge from the PACU. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Oraluxna Rodanant, MD | Anesthesiology Department, Faculty of Medicine, Culalongkorn University. | Principal Investigator |
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| ID | Title | Description |
|---|---|---|
| FG000 | Deep Neuromuscular Blockade Arm | After initial doses of 0.6 mg Rocuronium, a continuous infusion can be initiated to maintain 0 responses to train-of-four (TOF) stimulation or 1-2 responses to Post-Tetanic Count (PTC) (Deep NMB). The pump rate will vary and depends on the PTC value. The initial pump rate will be set at 0.5 mg/kg per hour. In case of a deviation from the required PTC value the pump rate can be increased or decreased. This was left to the discretion of the attending anaesthetist. Deep NMB should be maintained throughout the operation. The infusion of Rocuronium will be discontinued and Sugammadex will be given 4 mg/kg at the end of surgery, which is from deep NMB (PTC = 1-2). Deep Neuromuscular Blockade: - During maintenance phase, if recovery after 1 Post-Tetanic-count (PTC) responses, a continuous infusion can be initiated to maintain deep NMB (TOF =0, PTC 1-2). - At the end of surgery, continuous infusion Rocuronium and Propofol are discontinued and paralysis will be simultaneously reversed by |
| FG001 | Moderate Neuromuscular Blockade Arm | After evidence of early spontaneous recovery (< 10% of control T1) from initial doses of 0.6 mg rocuronium, a continuous infusion can be initiated to maintain 1 to 2 responses to train-of-four stimulation (Moderate NMB). The initial pump rate will be set at 0.5 mg/kg per hour. In case of a deviation from the required TOF value the pump rate can be increased or decreased. This was left to the discretion of the attending anaesthesiologist. Moderate paralysis should be maintained throughout an operation. At the end of surgery, the infusion of Rocuronium will be discontinued and Sugammadex 2 mg/kg via bolus injections]will be administered at least reappearance of T2. Moderate Neuromuscular Blockade: - During maintenance phase, if recovery at the presence of <10% of control T1 of TOF from initial doses of 0.6 mg rocuronium, a continuous infusion can be initiated to maintain TOF = 1 - 2. The initial pump rate will be set at 0.5 mg/kg per hour. Sugammadex Rocuronium |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Deep Neuromuscular Blockade Arm | After initial doses of 0.6 mg Rocuronium, a continuous infusion can be initiated to maintain 0 responses to train-of-four (TOF) stimulation or 1-2 responses to Post-Tetanic Count (PTC) (Deep NMB). The pump rate will vary and depends on the PTC value. The initial pump rate will be set at 0.5 mg/kg per hour. In case of a deviation from the required PTC value the pump rate can be increased or decreased. This was left to the discretion of the attending anaesthetist. Deep NMB should be maintained throughout the operation. The infusion of Rocuronium will be discontinued and Sugammadex will be given 4 mg/kg at the end of surgery, which is from deep NMB (PTC = 1-2). |
| 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 |
| 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 | Proportion of Patients Who Have a Clinically Acceptable Surgical Conditions | Proportion of patients who have a excellent and good surgical condition score | Posted | Number | Proportion of patients | intraoperative |
|
1 year and 9 months
Adverse Event reporting description based on Clinicaltrials.gov definition.
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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 Blockade Arm | Deep Neuromuscular Blockade: - During maintenance phase, if recovery after 1 Post-Tetanic-count (PTC) responses, a continuous infusion can be initiated to maintain deep NMB (TOF =0, PTC 1-2). - At the end of surgery, continuous infusion Rocuronium and Propofol are discontinued and paralysis will be simultaneously reversed by Sugammadex 4mg/kg from PTC 1-2. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Prok Laosuwan | Department of Anesthesiology, King Chulalongkorn Memorial Hospital | +66 2256 4295 | plaospir@yahoo.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 6, 2015 | Dec 18, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000077122 | Sugammadex |
| D000077123 | Rocuronium |
| ID | Term |
|---|---|
| D047408 | gamma-Cyclodextrins |
| D003505 | Cyclodextrins |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
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|
| Moderate Neuromuscular Blockade | Procedure | - During maintenance phase, if recovery at the presence of <10% of control T1 of TOF from initial doses of 0.6 mg rocuronium, a continuous infusion can be initiated to maintain TOF = 1 - 2. The initial pump rate will be set at 0.5 mg/kg per hour. |
|
| Sugammadex | Drug |
|
| Rocuronium | Drug |
|
| BG001 | Moderate Neuromuscular Blockade Arm | After evidence of early spontaneous recovery (< 10% of control T1) from initial doses of 0.6 mg rocuronium, a continuous infusion can be initiated to maintain 1 to 2 responses to train-of-four stimulation (Moderate NMB). The initial pump rate will be set at 0.5 mg/kg per hour. In case of a deviation from the required TOF value the pump rate can be increased or decreased. This was left to the discretion of the attending anaesthesiologist. Moderate paralysis should be maintained throughout an operation. At the end of surgery, the infusion of Rocuronium will be discontinued and Sugammadex 2 mg/kg via bolus injections]will be administered at least reappearance of T2. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | Year |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| BMI | Mean | Standard Deviation | "kg/m^2" |
|
|
|
| Secondary | Time to Modified Aldrete's Score ≥ 9 | Time from Post Anesthesia Care Unit (PACU) arrival to patients were considered fit for discharge from the PACU by Modified Aldrete's score assessment which scale range is from 0-10. Higher value represents a better outcome. | Posted | Median | Inter-Quartile Range | Minutes | Minutes from Post Anesthesia Care Unit (PACU) arrival to patients were considered fit for discharge from the PACU. |
|
|
|
| 0 |
| 49 |
| 0 |
| 49 |
| 0 |
| 49 |
| EG001 | Moderate Neuromuscular Blockade Arm | Moderate Neuromuscular Blockade: - During maintenance phase, if recovery at the presence of <10% of control T1 of TOF from initial doses of 0.6 mg rocuronium, a continuous infusion can be initiated to maintain TOF = 1 - 2. The initial pump rate will be set at 0.5 mg/kg per hour. | 0 | 48 | 0 | 48 | 0 | 48 |
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| D003912 |
| Dextrins |
| D013213 | Starch |
| D005936 | Glucans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D000732 | Androstanols |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |