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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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A deep neuromuscular block (NMB) is often associated with improved surgical conditions especially in laparoscopic surgery. We previously showed that deep NMB is superior to a moderate NMB under propofol anesthesia. However, this may not apply to sevoflurane anesthesia and sevoflurane by itself produces some degree of muscle relaxation. We therefore plan to investigate the effect of deep NMB on surgical conditions under sevoflurane anesthesia maintenance.
Neuromuscular blocking agents (NMBAs) are routinely administered during general anaesthesia to facilitate endotracheal intubation and to optimize surgical conditions. Increasing data suggest superiority of a deep neuromuscular block (defined by a post-tetanic count of 1-2 twitches) in creating optimal working conditions for the surgical team. However, it is unknown whether other aspects of the anaesthetic technique, most notably the choice of anaesthetic (for example, total intravenous versus inhalational anaesthesia), influence the relationship between the depth of the neuromuscular block and surgical conditions, particularly in laparoscopic surgery. Volatile anaesthetics are known for their ability to potentiate neuromuscular blocking agents an effect that is less existent with propofol. We previously showed that surgical working conditions in laparoscopic surgery during propofol anaesthesia are highly reliant on the depth of the neuromuscular block. Whether such a relationship also exists for inhalational anaesthetics, is unknown. To investigate this, we conducted a prospective, randomized, double blind study in which patients scheduled for laparoscopic renal surgery were randomized to receive either a moderate or a deep neuromuscular block during sevoflurane anaesthesia. The primary outcome was the intraoperative surgical condition assessed by a surgeon using the validated Leiden-Surgical Rating Scale. We hypothesized that the use of an inhalational anaesthetic would obviate the need for a deep NMB due to its intrinsic muscle relaxant potentiating properties to produce optimal working conditions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Moderate neuromuscular block | No Intervention | Subjects will receive moderate neuromuscular block, aimed at 1-2 twitches train of four | |
| Deep neuromuscular block | Experimental | Subjects will receive deep neuromuscular block, aimed at 1-2 twitches post tetanic count |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Deep neuromuscular block | Drug | Deep neuromuscular block will be achieved with high dose rocuronium to achieve a depth of 1-2 twitches post tetanic count |
|
| Measure | Description | Time Frame |
|---|---|---|
| Leiden Surgical Rating Scale | During the on average 3 hour procedure, the surgical condition will be scored by the surgeon using a 5-point surgical rating scale at 15 minute intervals(1: poor ; 5: optimal) Mean and standard deviation of the average of all leiden surgical rating scale will be reported. | during surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Measurements and Outcomes; Pain Scores | Postoperative measurements and outcomes of during PACU stay, all scores are reported as means and standard deviation of the average over the follow up period -mean pain scores (numeric rating scale; 0 no pain - 10 worst pain imaginable) | During post-anesthetic care unit stay (average stay 2 hours) at 15 minute intervals |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Albert Dahan, MD PhD | LUMC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Leiden University Medical Center | Leiden | Netherlands |
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| ID | Title | Description |
|---|---|---|
| FG000 | Moderate Neuromuscular Block | Subjects will receive moderate neuromuscular block, aimed at 1-2 twitches train of four |
| FG001 | Deep Neuromuscular Block | Subjects will receive deep neuromuscular block, aimed at 1-2 twitches post tetanic count Deep neuromuscular block: Deep neuromuscular block will be achieved with high dose rocuronium to achieve a depth of 1-2 twitches post tetanic count |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Moderate Neuromuscular Block | Moderate neuromuscular block. In patients that were randomized to receive a moderate neuromuscular block, a bolus dose of rocuronium 0.5 mg kg-1 was administered, followed by intermittent injections of rocuronium 10-20 mg, aimed at keeping the train-of-four count at 1-2 twitches. At the end of the procedure, reversal of the neuromuscular block was by administration of sugammadex (2 mg kg-1). Patients were extubated when the train-of-four ratio reached 1.0, were breathing spontaneously and were awake. |
| 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 |
| 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 | Leiden Surgical Rating Scale | During the on average 3 hour procedure, the surgical condition will be scored by the surgeon using a 5-point surgical rating scale at 15 minute intervals(1: poor ; 5: optimal) Mean and standard deviation of the average of all leiden surgical rating scale will be reported. | Posted | Mean | Standard Deviation | score on a scale | during surgery |
|
Seven days post-procedure follow-up period
The definition of adverse events is comparable to the definition by this website
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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 | Moderate neuromuscular block. In patients that were randomized to receive a moderate neuromuscular block, a bolus dose of rocuronium 0.5 mg kg-1 was administered, followed by intermittent injections of rocuronium 10-20 mg, aimed at keeping the train-of-four count at 1-2 twitches. At the end of the procedure, reversal of the neuromuscular block was by administration of sugammadex (2 mg kg-1). Patients were extubated when the train-of-four ratio reached 1.0, were breathing spontaneously and were awake. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| prolonged hospital stay | Surgical and medical procedures | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Postoperative CT-scan | Surgical and medical procedures | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Drs. Maarten Honing | LUMC | 0715264038 | g.h.m.honing@lumc.nl |
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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 | Nov 1, 2017 | Oct 16, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000077123 | Rocuronium |
| ID | Term |
|---|---|
| D000732 | Androstanols |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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|
| Intraoperative Hemodynamic Conditions | Perioperative average blood pressure will be reported, mean blood pressure ranging from 65 tot 110 millimeters mercury is considered normal | Perioperative measurements at 15 minute interval (on average during 3 hours) |
| Postoperative Measurements and Outcomes; Sedation Levels | Postoperative measurements and outcomes of during PACU stay, all scores are reported as means and standard deviation of the average over the follow up period -ramsay sedation levels (0 = normal alertness, eyes open, responds normal to command 1 = drowsy with open eyes, closed and opened on command 2 = drowsy with closed eyes, opened in response to light auditory stimulus 3 = eyes closed, opened in response to rubbing the shoulder or a loud auditory stimulus 4 = eyes closed and opened only briefly in response to touching the subject 5 = eyes closed, unarousable by touch, aroused by painful 6 = unarousable by pain) | During post-anesthetic care unit stay (average stay 2 hours) at 15 minute intervals |
| Postoperative Measurements and Outcomes; Saturation | Postoperative measurements and outcomes of during PACU stay, all scores are reported as means and standard deviation of the average over the follow up period -blood oxygen saturation in percent levels between 95-100 are considered normal | During post-anesthetic care unit stay (average stay 2 hours) at 15 minute intervals |
| Intraoperative Nociception Level | The median and full range of the average nociception level index will be reported. The nociception level index consist of Ta multiparameter nonlinear combination of heart rate, heart rate variability, amplitude of the finger photoplethysmogram, skin conductance level, fluctuations in skin conductance, and their time derivatives, derived from random forest regression. Random forest is an algorithmic modeling approach that enables combining multiple parameters of different origin and discovering their complex nonlinear interactions. Normal range is between 10-20; 0 indicates no nociceptive events (in example, pain stimuli), 100 indicates severe painful stimuli. | Perioperative measurements at 15 minute interval (on average during 3 hours) |
| BG001 | Deep Neuromuscular Block | In patients that were randomized to receive a deep neuromuscular block, a bolus dose of rocuronium 1.0 mg kg-1 was administered, followed by a continuous rocuronium infusion. The infusion rate was started at 0.3 mg kg-1 h-1 and titrated to keep the post-tetanic count at 1-2 twitches throughout the procedure. In case the surgeon scored Leiden-Surgical Rating Scale 1 or 2 (extremely poor or poor conditions), a bolus of rocuronium 10 mg could be administered. At the end of the procedure, reversal of the neuromuscular block was achieved with the administration of sugammadex 2-4 mg kg-1. Patients were extubated when the train-of-four ratio reached 1.0. |
| 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 | Number | participants |
|
| Procedure | Number | Laparoscopic renal surgery |
|
| Height (m) | Mean | Standard Deviation | m |
|
| Weight (kg) | Mean | Standard Deviation | kg |
|
| American Society of Anesthesiologists physical status classification system | I A normal healthy patient II A patient with mild systemic disease III A patient with severe systemic disease IV A patient with severe systemic disease that is a constant threat to life V A moribund patient who is not expected to survive without the operation VI A declared brain-dead patient whose organs are being removed for donor purposes | Count of Participants | Participants |
|
|
|
|
| Secondary | Postoperative Measurements and Outcomes; Pain Scores | Postoperative measurements and outcomes of during PACU stay, all scores are reported as means and standard deviation of the average over the follow up period -mean pain scores (numeric rating scale; 0 no pain - 10 worst pain imaginable) | Posted | Mean | Standard Deviation | units on a scale | During post-anesthetic care unit stay (average stay 2 hours) at 15 minute intervals |
|
|
|
| Secondary | Intraoperative Hemodynamic Conditions | Perioperative average blood pressure will be reported, mean blood pressure ranging from 65 tot 110 millimeters mercury is considered normal | Posted | Median | Full Range | millimeters mercury | Perioperative measurements at 15 minute interval (on average during 3 hours) |
|
|
|
| Secondary | Postoperative Measurements and Outcomes; Sedation Levels | Postoperative measurements and outcomes of during PACU stay, all scores are reported as means and standard deviation of the average over the follow up period -ramsay sedation levels (0 = normal alertness, eyes open, responds normal to command 1 = drowsy with open eyes, closed and opened on command 2 = drowsy with closed eyes, opened in response to light auditory stimulus 3 = eyes closed, opened in response to rubbing the shoulder or a loud auditory stimulus 4 = eyes closed and opened only briefly in response to touching the subject 5 = eyes closed, unarousable by touch, aroused by painful 6 = unarousable by pain) | Posted | Mean | Standard Deviation | units on a scale | During post-anesthetic care unit stay (average stay 2 hours) at 15 minute intervals |
|
|
|
| Secondary | Postoperative Measurements and Outcomes; Saturation | Postoperative measurements and outcomes of during PACU stay, all scores are reported as means and standard deviation of the average over the follow up period -blood oxygen saturation in percent levels between 95-100 are considered normal | Posted | Mean | Standard Deviation | percentage of blood oxygen saturation | During post-anesthetic care unit stay (average stay 2 hours) at 15 minute intervals |
|
|
|
| Secondary | Intraoperative Nociception Level | The median and full range of the average nociception level index will be reported. The nociception level index consist of Ta multiparameter nonlinear combination of heart rate, heart rate variability, amplitude of the finger photoplethysmogram, skin conductance level, fluctuations in skin conductance, and their time derivatives, derived from random forest regression. Random forest is an algorithmic modeling approach that enables combining multiple parameters of different origin and discovering their complex nonlinear interactions. Normal range is between 10-20; 0 indicates no nociceptive events (in example, pain stimuli), 100 indicates severe painful stimuli. | Posted | Median | Full Range | score on a scale | Perioperative measurements at 15 minute interval (on average during 3 hours) |
|
|
|
| 0 |
| 49 |
| 5 |
| 49 |
| 3 |
| 49 |
| EG001 | Deep NMB | In patients that were randomized to receive a deep neuromuscular block, a bolus dose of rocuronium 1.0 mg kg-1 was administered, followed by a continuous rocuronium infusion. The infusion rate was started at 0.3 mg kg-1 h-1 and titrated to keep the post-tetanic count at 1-2 twitches throughout the procedure. In case the surgeon scored Leiden-Surgical Rating Scale 1 or 2 (extremely poor or poor conditions), a bolus of rocuronium 10 mg could be administered. At the end of the procedure, reversal of the neuromuscular block was achieved with the administration of sugammadex 2-4 mg kg-1. Patients were extubated when the train-of-four ratio reached 1.0. | 0 | 49 | 2 | 49 | 2 | 49 |
| hospital readmission | Surgical and medical procedures | 2 | Systematic Assessment |
|
| Corneal Erosion | Surgical and medical procedures | Systematic Assessment |
|
| Reflex syncope | Surgical and medical procedures | Systematic Assessment |
|
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| D011083 |
| Polycyclic Compounds |