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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-005238-76 | EudraCT Number |
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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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The investigators hypothesize that an anesthetic protocol maintaining deep neuromuscular block throughout the entire surgical procedure followed by sugammadex reversal, would suppress EMG activity and result in improved anesthetic stability by reducing the variability of the Bispectral Index of the EEG, and be beneficial by reducing the total doses of the anesthetic drugs propofol and remifentanil required to maintain an adequate level of anesthesia (BIS between 40 and 60).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Group | No Intervention | Standard Clinical Practice Group - standard neuromuscular block, with a standard rocuronium dose for intubation (0.6 mg/kg). If required, the reversal of neuromuscular block is performed with neostigmine. | |
| Deep NMB group | Experimental | Deep Neuromuscular Block group - with a standard rocuronium dose for intubation (0.6 mg/kg), followed by a constant infusion of rocuronium (10-15 ug/kg/min) to guarantee a PTC less or equal to 2 on the TOF monitor (PTC is evaluated every 5 minutes). The reversal of neuromuscular block is performed with Sugammadex (4 mg/kg). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sugammadex | Drug | Reversal of deep neuromuscular block |
|
| Measure | Description | Time Frame |
|---|---|---|
| BIS Signal Variability Using the Measured Standard Deviation During the Maintenance Phase of Anesthesia | BIS (Bispetral Index of the EEG) sample standard deviation during the maintenance phase of anesthesia was used as a measure of signal variability, maintenance phase is defined as the time between the first time the BIS signal drops below 60 after loss of consciousness, until the time the BIS signal goes above 60 after the propofol infusion is stopped. BIS signal varies between 0 to 100. BIS values near 100 represent an "awake" clinical state while 0 denotes the maximal effect an isoelectric EEG. The aim was to maintain the BIS value within a target range of 40 to 60. The higher the BIS sample standard deviation the higher the oscillation around the sample mean. | Maintenance of anesthesia, an average of 130 minutes |
| Required Effect-site Concentrations of Propofol and Remifentanil | Mean effect-site concentration of propofol required during maintenance of anesthesia (using target controlled infusion). Mean effect-site concentration of remifentanil required during maintenance of anesthesia (using target controlled infusion). | Maintenance of anesthesia, an average of 130 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| PQRS Results at 15 and 40 Minutes After Surgery (Taking Into Account the Patient Baseline Values of the PQRS Test Done on the Preanesthetic Visit) | PQRS(Post-operative Quality Recovery Scale) recovery rate at 15 minutes post surgery and PQRS recovery rate at 40 minutes post surgery. Recovery is defined as returning to PQRS baseline values. | 15 and 40 minutes after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pedro Amorim, MD | Centro Hospitalar do Porto | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro Hospitalar do Porto | Porto | 4099-001 | Portugal |
3 patients were excluded from the study after screening (signing the informed consent) but before randomization and assignment to the groups, due to:
Recruitment started on the 2016/9/19 and finished on 2017/6/28 at Centro Hospitalar do Porto, Portugal.
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard Group | Standard Clinical Practice Group - standard neuromuscular block, with a standard rocuronium dose for intubation (0.6 mg/kg). If required, the reversal of neuromuscular block is performed with neostigmine. |
| FG001 | Deep NMB Group | Deep Neuromuscular Block group - with a standard rocuronium dose for intubation (0.6 mg/kg), followed by a constant infusion of rocuronium (10-15 ug/kg/min) to guarantee a PTC less or equal to 2 on the TOF monitor (PTC is evaluated every 5 minutes). The reversal of neuromuscular block is performed with Sugammadex (4 mg/kg). Sugammadex: Reversal of deep neuromuscular block Rocuronium: Maintenance of deep neuromuscular block |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard Group | Standard Clinical Practice Group - standard neuromuscular block, with a standard rocuronium dose for intubation (0.6 mg/kg). If required, the reversal of neuromuscular block is performed with neostigmine. |
| BG001 | Deep NMB Group |
| 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 | BIS Signal Variability Using the Measured Standard Deviation During the Maintenance Phase of Anesthesia | BIS (Bispetral Index of the EEG) sample standard deviation during the maintenance phase of anesthesia was used as a measure of signal variability, maintenance phase is defined as the time between the first time the BIS signal drops below 60 after loss of consciousness, until the time the BIS signal goes above 60 after the propofol infusion is stopped. BIS signal varies between 0 to 100. BIS values near 100 represent an "awake" clinical state while 0 denotes the maximal effect an isoelectric EEG. The aim was to maintain the BIS value within a target range of 40 to 60. The higher the BIS sample standard deviation the higher the oscillation around the sample mean. | Posted | Mean | Standard Deviation | units on a scale | Maintenance of anesthesia, an average of 130 minutes |
|
Adverse event data were collected by the researchers up to 3 days after surgery.
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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 | Standard Group | Standard Clinical Practice Group - standard neuromuscular block, with a standard rocuronium dose for intubation (0.6 mg/kg). If required, the reversal of neuromuscular block is performed with neostigmine. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Emergence delirium | Nervous system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof. Catarina S Nunes | Universidade Aberta, Mathematics Section | +351 300 001 705 | cnunes@bio-mathematics.org |
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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 | Jan 26, 2016 | Dec 2, 2018 | 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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| Rocuronium | Drug | Maintenance of deep neuromuscular block |
|
|
| PQRS Satisfaction Results at Day 3 After Surgery | Patient satisfaction with anesthetic care rated as: Not satisfied, A little satisfied, Moderately satisfied ,Satisfied, Totally Satisfied | 3rd day after surgery |
| Time of the procedure less than 90 min. |
|
Deep Neuromuscular Block group - with a standard rocuronium dose for intubation (0.6 mg/kg), followed by a constant infusion of rocuronium (10-15 ug/kg/min) to guarantee a PTC less or equal to 2 on the TOF monitor (PTC is evaluated every 5 minutes). The reversal of neuromuscular block is performed with Sugammadex (4 mg/kg). Sugammadex: Reversal of deep neuromuscular block Rocuronium: Maintenance of deep neuromuscular block |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Mean Arterial Pressure | Mean | Standard Deviation | mmHg |
|
| OG001 | Deep NMB Group | Deep Neuromuscular Block group - with a standard rocuronium dose for intubation (0.6 mg/kg), followed by a constant infusion of rocuronium (10-15 ug/kg/min) to guarantee a PTC less or equal to 2 on the TOF monitor (PTC is evaluated every 5 minutes). The reversal of neuromuscular block is performed with Sugammadex (4 mg/kg). Sugammadex: Reversal of deep neuromuscular block Rocuronium: Maintenance of deep neuromuscular block |
|
|
|
| Primary | Required Effect-site Concentrations of Propofol and Remifentanil | Mean effect-site concentration of propofol required during maintenance of anesthesia (using target controlled infusion). Mean effect-site concentration of remifentanil required during maintenance of anesthesia (using target controlled infusion). | Posted | Mean | Standard Deviation | ng/ml | Maintenance of anesthesia, an average of 130 minutes |
|
|
|
|
| Secondary | PQRS Results at 15 and 40 Minutes After Surgery (Taking Into Account the Patient Baseline Values of the PQRS Test Done on the Preanesthetic Visit) | PQRS(Post-operative Quality Recovery Scale) recovery rate at 15 minutes post surgery and PQRS recovery rate at 40 minutes post surgery. Recovery is defined as returning to PQRS baseline values. | 10 patients were not able to complete the PQRS test at 15 minutes, since they were not able to communicate or understand the questions. 1 patient was not able to complete the PQRS test at 15 and 40 minutes due to problems in the vocal cords. | Posted | Count of Participants | Participants | 15 and 40 minutes after surgery |
|
|
|
|
| Secondary | PQRS Satisfaction Results at Day 3 After Surgery | Patient satisfaction with anesthetic care rated as: Not satisfied, A little satisfied, Moderately satisfied ,Satisfied, Totally Satisfied | 4 patients did not complete the questionnaire on the 3rd day, since they did not pick up the phone. | Posted | Count of Participants | Participants | 3rd day after surgery |
|
|
|
|
| 0 |
| 35 |
| 0 |
| 35 |
| 2 |
| 35 |
| EG001 | Deep NMB Group | Deep Neuromuscular Block group - with a standard rocuronium dose for intubation (0.6 mg/kg), followed by a constant infusion of rocuronium (10-15 ug/kg/min) to guarantee a PTC less or equal to 2 on the TOF monitor (PTC is evaluated every 5 minutes). The reversal of neuromuscular block is performed with Sugammadex (4 mg/kg). Sugammadex: Reversal of deep neuromuscular block Rocuronium: Maintenance of deep neuromuscular block | 0 | 35 | 0 | 35 | 6 | 35 |
| Neck pain | Surgical and medical procedures | Systematic Assessment | Neck pain after discharge |
|
| Nausea and urinary retention | General disorders | Systematic Assessment | Nausea and urinary retention in the recovery |
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| Tachycardia | Cardiac disorders | Systematic Assessment | Tachycardia of 120bpm in the recovery |
|
| Post-operative hypertension | General disorders | Systematic Assessment | Post-operative hypertension in the recovery room (Systolic Pressure 220 mmHg) |
|
| Asystole of 20 seconds | Cardiac disorders | Systematic Assessment | Asystole of 20 seconds during laryngoscopy resolved with IV atropine |
|
| Post-operative dyspnea and anxiety | Surgical and medical procedures | Systematic Assessment | Post-operative dyspnea and anxiety, shown on ENT examination, to have been caused by vocal cord paralysis due to a surgical complication |
|
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| D003912 |
| Dextrins |
| D013213 | Starch |
| D005936 | Glucans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D000732 | Androstanols |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
|
This statistical analysis applies to the remifentanil effect-site concentration. Sample size calculation was performed with a power of 0.80 and an α of 0.05 also a reduction in the remifentanil drug consumption (measured as the average effect-site concentration) during maintenance of anesthesia. A reduction on on remifentanil average effect-site concentration of 20% was considered clinically relevant, giving a minimum of 24 patients per group |
| t-test, 2 sided |
| 0.245 |
| Superiority |
| Did not recovered |
|
| 40 minutes |
|
|
| Fisher Exact |
| 0.107 |
| Superiority |
| Moderately satisfied |
|
| A little satisfied |
|
| Not satisfied |
|