Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2007-006934-33 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The clinical trial objectives were to evaluate the dialysability of the sugammadex-rocuronium complex; it's safety and efficacy in participants with severe renal impairment.
The current trial was designed to evaluate the dialysability of the sugammadex-rocuronium complex in participants with severe renal impairment. A dose of 4.0 mg/kg sugammadex was administered 15 minutes after administration of 0.6 mg/kg rocuronium. Blood and dialysate samples were collected before, during and after hemodialysis/filtration, for calculation of clearance of sugammadex-rocuronium complex and assessment of rebound.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sugammadex | Experimental | IV single bolus dose of 4.0 mg/kg sugammadex |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sugammadex | Drug | At 15 minutes after administration of rocuronium, an IV single bolus dose of 4.0 mg/kg sugammadex was administered. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clearance of Sugammadex by Dialysis as Measured by the Reduction Ratio (RR) | Starting on Day 1 dialysis was performed on four separate occasions using a Fresenius 40008H hemodialyzer, with a hemodiafilter standard helixone membrane FX 600. Dialysate samples were collected before, and after hemodialysis, with concentrations of sugammadex determined using a liquid chromatographic assay with mass spectrometric detection. The clearance of sugammadex at each dialysis session was calculated by measuring the ratio of plasma concentration at the end of dialysis, average duration of 6 hours, compared with that immediately before the start of dialysis, called the RR. | Up to day 7 |
| Clearance of Rocuronium by Dialysis as Measured by the Reduction Ratio (RR) | Starting on Day 1 dialysis was performed on four separate occasions using a Fresenius 40008H hemodialyzer, with a hemodiafilter standard helixone membrane FX 600. Dialysate samples were collected before, and after hemodialysis, with concentrations of rocuronium determined using a liquid chromatographic assay with mass spectrometric detection. The clearance of rocuronium at each dialysis session was calculated by measuring the ratio of plasma concentration at the end of dialysis, average duration of 6 hours, compared with that immediately before the start of dialysis, called the RR. | Up to Day 7 |
| Rate of Clearance of Sugammadex From Blood | Starting on Day 1 dialysis was performed on four separate occasions using a Fresenius 40008H hemodialyzer, with a hemodiafilter standard helixone membrane FX 600. Blood samples were collected from ports in the arterial and venous tubing of the dialyzer before, during and after an average of 6 hours of hemodialysis. The concentrations of sugammadex were determined using a liquid chromatographic assay with mass spectrometric detection. The clearance rate from blood at each dialysis session was assessed by averaging across all available collection time points. | Up to day 7 |
| Rate of Clearance of Rocuronium From Blood |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Pre-treatment Adverse Events (AEs) | An AE is any unfavorable and unintended change in the structure, function or chemistry of the body, whether or not related to the use of a product. | Screening up to Day 1 |
| Number of Participants With Serious Adverse Events (SAEs) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22732111 | Result | Cammu G, Van Vlem B, van den Heuvel M, Stet L, el Galta R, Eloot S, Demeyer I. Dialysability of sugammadex and its complex with rocuronium in intensive care patients with severe renal impairment. Br J Anaesth. 2012 Sep;109(3):382-90. doi: 10.1093/bja/aes207. Epub 2012 Jun 24. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Sugammadex | Intravenous (IV) single bolus dose of 4.0 mg/kg sugammadex |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Sugammadex | IV single bolus dose of 4.0 mg/kg sugammadex |
| 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 | Clearance of Sugammadex by Dialysis as Measured by the Reduction Ratio (RR) | Starting on Day 1 dialysis was performed on four separate occasions using a Fresenius 40008H hemodialyzer, with a hemodiafilter standard helixone membrane FX 600. Dialysate samples were collected before, and after hemodialysis, with concentrations of sugammadex determined using a liquid chromatographic assay with mass spectrometric detection. The clearance of sugammadex at each dialysis session was calculated by measuring the ratio of plasma concentration at the end of dialysis, average duration of 6 hours, compared with that immediately before the start of dialysis, called the RR. | All subjects pharmacokinetically evaluable consisting of all participants who received a dose of sugammadex and had at least one efficacy measurement | Posted | Mean | Standard Deviation | Reduction Ratio | Up to day 7 |
|
Up to 7 days after administration of sugammadex
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sugammadex | IV single bolus dose of 4.0 mg/kg sugammadex |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac failure | Cardiac disorders | MedDRA 12.1 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 12.1 |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D000077122 | Sugammadex |
| D000077123 | Rocuronium |
| ID | Term |
|---|---|
| D047408 | gamma-Cyclodextrins |
| D003505 | Cyclodextrins |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Rocuronium | Drug | After achieving stable anesthesia an IV single bolus dose of 0.6 mg/kg rocuronium was administered |
|
|
Starting on Day 1 dialysis was performed on four separate occasions using a Fresenius 40008H hemodialyzer, with a hemodiafilter standard helixone membrane FX 600. Blood samples were collected from ports in the arterial and venous tubing of the dialyzer before, during and after an average of 6 hours of hemodialysis. The concentrations of rocuronium were determined using a liquid chromatographic assay with mass spectrometric detection. The clearance rate from blood at each dialysis session was assessed by averaging across all available collection time points.
| Up to Day 7 |
| Rate of Clearance of Sugammadex From Dialysate | Starting on Day 1 dialysis was performed on four separate occasions using a Fresenius 40008H hemodialyzer, with a hemodiafilter standard helixone membrane FX 600. Dialysate samples were collected from a port in the outflow of the dialyzer before, during and after an average of 6 hours of hemodialysis. The concentrations of sugammadex were determined using a liquid chromatographic assay with mass spectrometric detection. The clearance rate from dialysate at each dialysis session was assessed by averaging across all available collection time points.The data from the fourth dialysis are not presented as they were not calculable. | Up to day 7 |
| Rate of Clearance of Rocuronium From Dialysate | Starting on Day 1 dialysis was performed on four separate occasions using a Fresenius 40008H hemodialyzer, with a hemodiafilter standard helixone membrane FX 600. Dialysate samples were collected from a port in the outflow of the dialyzer before, during and after an average of 6 hours of hemodialysis. The concentrations of rocuronium were determined using a liquid chromatographic assay with mass spectrometric detection. The clearance rate from dialysate at each dialysis session was assessed by averaging across all available collection time points. | Up to Day 7 |
A SAE is any untoward medical occurrence that at any dose results in the following: death, is life threatening, requires in-patient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, or is a congenital anomaly/birth defect |
| Up to day 7 |
| Number of Participants With Medical Device (Near) Incidents | A medical device (near) incident is defined as an occurrence due to inaccurate or inadequate labeling/instructions, or information supplied with a medical device; or malfunction, deterioration or recall of a medical device that could lead to death or serious deterioration in health. | Up to day 7 |
| Vital Sign: Mean Systolic Blood Pressure | Systolic blood pressure was measured at the following time points: screening, before rocuronium treatment, before sugammadex treatment, at 2, 5, 10, 20 minutes post-sugammadex treatment, and the day after surgery | Screening up to 1 day after surgery |
| Vital Sign: Mean Diastolic Blood Pressure | Diastolic blood pressure was measured at the following time points: screening, before rocuronium treatment, before sugammadex treatment, at 2, 5, 10, 20 minutes post-sugammadex treatment, and the day after surgery | Screening up to 1 day after surgery |
| Vital Sign: Mean Heart Rate | Heart rate was measured at the following time points: screening, before rocuronium treatment, before sugammadex treatment, at 2, 5, 10, 20 minutes post-sugammadex treatment, and the day after surgery | Screening up to 1 day after surgery |
| Number of Participants With Physical Examinations | Physical examinations were to be conducted at screening, on Day 1 and 7 days after surgery | Screening up to day 7 |
| Number of Participants With Reoccurrence of Neuromuscular Blockade at Day 1 | Neuromuscular function was monitored by applying repetitive train of four (TOF) electrical stimulations to the ulnar nerve every 15 seconds and assessing the magnitudes (heights) of the first twitch (T1) and fourth twitch (T4) response at the adductor pollicis muscle with a TOF-Watch® SX. Stimulation continued until the T4/T1 ratio reached at least 0.9. Higher T4/T1 ratios represent greater recovery from neuromuscular blockade; with a value of 1.0 representing full recovery. Reoccurrence of neuromuscular blockade is defined as a decline in the T4/T1 ratio from >= 0.9 to < 0.8 in at least three consecutive measurements. | Day 1 |
| Number of Participants With Events Due to Possible Interaction of Sugammadex With Endo-/Exogenous Compounds Other Than Rocuronium | Evidence of AEs due to possible interaction of sugammadex with endogenous compounds or with exogenous compounds other than rocuronium | Day 1 |
| Number of Participants With Pregnancies at 30 Days Post-dose | Pregnancies reported by means of a Pregnancy Reporting Form, consist of pregnant female participants or pregnant female partners of male participants | Up to 30 days post -dose |
| Time From Start of Administration of Sugammadex to Recovery of T4/T1 Ratio to 0.9 | Neuromuscular function was monitored by applying repetitive train of four (TOF) electrical stimulations to the ulnar nerve every 15 seconds and assessing the magnitudes (heights) of the first twitch (T1) and fourth twitch (T4) response at the adductor pollicis muscle with a TOF-Watch® SX. Stimulation continued until the T4/T1 ratio reached at least 0.9. Higher T4/T1 ratios represent greater recovery from neuromuscular blockade; with a value of 1.0 representing full recovery. | Day 1 |
| Time From Start of Administration of Sugammadex to Recovery of T4/T1 Ratio to 0.8 | Neuromuscular function was monitored by applying repetitive TOF electrical stimulations to the ulnar nerve every 15 seconds and assessing the magnitudes (heights) of the T1 and T4 response at the adductor pollicis muscle with a TOF-Watch® SX. Stimulation continued until the T4/T1 ratio reached at least 0.8. Higher T4/T1 ratios represent greater recovery from neuromuscular blockade; with a value of 1.0 representing full recovery. | Day 1 |
| Time From Start of Administration of Sugammadex to Recovery of T4/T1 Ratio to 0.7 | Neuromuscular function was monitored by applying repetitive TOF electrical stimulations to the ulnar nerve every 15 seconds and assessing the magnitudes (heights) of the T1 and T4 response at the adductor pollicis muscle with a TOF-Watch® SX. Stimulation continued until the T4/T1 ratio reached at least 0.7. Higher T4/T1 ratios represent greater recovery from neuromuscular blockade; with a value of 1.0 representing full recovery. | Day 1 |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
IV single bolus dose of 4.0 mg/kg sugammadex
|
|
| Secondary | Number of Participants With Pre-treatment Adverse Events (AEs) | An AE is any unfavorable and unintended change in the structure, function or chemistry of the body, whether or not related to the use of a product. | All Subjects Treated (AST) consisting of participants who received a dose of sugammadex | Posted | Number | participants | Screening up to Day 1 |
|
|
|
| Secondary | Number of Participants With Serious Adverse Events (SAEs) | A SAE is any untoward medical occurrence that at any dose results in the following: death, is life threatening, requires in-patient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, or is a congenital anomaly/birth defect | AST consisting of all participants who received a dose of sugammadex | Posted | Number | participants | Up to day 7 |
|
|
|
| Secondary | Number of Participants With Medical Device (Near) Incidents | A medical device (near) incident is defined as an occurrence due to inaccurate or inadequate labeling/instructions, or information supplied with a medical device; or malfunction, deterioration or recall of a medical device that could lead to death or serious deterioration in health. | AST consisting of all participants who received a dose of sugammadex | Posted | Number | participants | Up to day 7 |
|
|
|
| Secondary | Vital Sign: Mean Systolic Blood Pressure | Systolic blood pressure was measured at the following time points: screening, before rocuronium treatment, before sugammadex treatment, at 2, 5, 10, 20 minutes post-sugammadex treatment, and the day after surgery | AST consisting of all participants who received a dose of sugammadex | Posted | Mean | Standard Deviation | mm Hg | Screening up to 1 day after surgery |
|
|
|
| Secondary | Vital Sign: Mean Diastolic Blood Pressure | Diastolic blood pressure was measured at the following time points: screening, before rocuronium treatment, before sugammadex treatment, at 2, 5, 10, 20 minutes post-sugammadex treatment, and the day after surgery | AST consisting of all participants who received a dose of sugammadex | Posted | Mean | Standard Deviation | mm Hg | Screening up to 1 day after surgery |
|
|
|
| Secondary | Vital Sign: Mean Heart Rate | Heart rate was measured at the following time points: screening, before rocuronium treatment, before sugammadex treatment, at 2, 5, 10, 20 minutes post-sugammadex treatment, and the day after surgery | AST consisting of all participants who received a dose of sugammadex | Posted | Mean | Standard Deviation | Beats per minute | Screening up to 1 day after surgery |
|
|
|
| Secondary | Number of Participants With Physical Examinations | Physical examinations were to be conducted at screening, on Day 1 and 7 days after surgery | AST consisting of all participants who received a dose of sugammadex | Posted | Number | participants | Screening up to day 7 |
|
|
|
| Secondary | Number of Participants With Reoccurrence of Neuromuscular Blockade at Day 1 | Neuromuscular function was monitored by applying repetitive train of four (TOF) electrical stimulations to the ulnar nerve every 15 seconds and assessing the magnitudes (heights) of the first twitch (T1) and fourth twitch (T4) response at the adductor pollicis muscle with a TOF-Watch® SX. Stimulation continued until the T4/T1 ratio reached at least 0.9. Higher T4/T1 ratios represent greater recovery from neuromuscular blockade; with a value of 1.0 representing full recovery. Reoccurrence of neuromuscular blockade is defined as a decline in the T4/T1 ratio from >= 0.9 to < 0.8 in at least three consecutive measurements. | AST consisting of all screened participants who received a dose of sugammadex | Posted | Number | participants | Day 1 |
|
|
|
| Secondary | Number of Participants With Events Due to Possible Interaction of Sugammadex With Endo-/Exogenous Compounds Other Than Rocuronium | Evidence of AEs due to possible interaction of sugammadex with endogenous compounds or with exogenous compounds other than rocuronium | AST consisting of all participants who received a dose of sugammadex | Posted | Number | participants | Day 1 |
|
|
|
| Secondary | Number of Participants With Pregnancies at 30 Days Post-dose | Pregnancies reported by means of a Pregnancy Reporting Form, consist of pregnant female participants or pregnant female partners of male participants | AST consisting of all participants who received a dose of sugammadex | Posted | Number | participants | Up to 30 days post -dose |
|
|
|
| Secondary | Time From Start of Administration of Sugammadex to Recovery of T4/T1 Ratio to 0.9 | Neuromuscular function was monitored by applying repetitive train of four (TOF) electrical stimulations to the ulnar nerve every 15 seconds and assessing the magnitudes (heights) of the first twitch (T1) and fourth twitch (T4) response at the adductor pollicis muscle with a TOF-Watch® SX. Stimulation continued until the T4/T1 ratio reached at least 0.9. Higher T4/T1 ratios represent greater recovery from neuromuscular blockade; with a value of 1.0 representing full recovery. | Intent To Treat (ITT) group consisting of participants who received a dose of sugammadex and had at least one efficacy measurement | Posted | Geometric Mean | 95% Confidence Interval | Minutes | Day 1 |
|
|
|
| Secondary | Time From Start of Administration of Sugammadex to Recovery of T4/T1 Ratio to 0.8 | Neuromuscular function was monitored by applying repetitive TOF electrical stimulations to the ulnar nerve every 15 seconds and assessing the magnitudes (heights) of the T1 and T4 response at the adductor pollicis muscle with a TOF-Watch® SX. Stimulation continued until the T4/T1 ratio reached at least 0.8. Higher T4/T1 ratios represent greater recovery from neuromuscular blockade; with a value of 1.0 representing full recovery. | ITT group consisting of participants who received a dose of sugammadex and had at least one efficacy measurement | Posted | Geometric Mean | 95% Confidence Interval | Minutes | Day 1 |
|
|
|
| Secondary | Time From Start of Administration of Sugammadex to Recovery of T4/T1 Ratio to 0.7 | Neuromuscular function was monitored by applying repetitive TOF electrical stimulations to the ulnar nerve every 15 seconds and assessing the magnitudes (heights) of the T1 and T4 response at the adductor pollicis muscle with a TOF-Watch® SX. Stimulation continued until the T4/T1 ratio reached at least 0.7. Higher T4/T1 ratios represent greater recovery from neuromuscular blockade; with a value of 1.0 representing full recovery. | ITT group consisting of participants who received a dose of sugammadex and had at least one efficacy measurement | Posted | Geometric Mean | 95% Confidence Interval | Minutes | Day 1 |
|
|
|
| Primary | Clearance of Rocuronium by Dialysis as Measured by the Reduction Ratio (RR) | Starting on Day 1 dialysis was performed on four separate occasions using a Fresenius 40008H hemodialyzer, with a hemodiafilter standard helixone membrane FX 600. Dialysate samples were collected before, and after hemodialysis, with concentrations of rocuronium determined using a liquid chromatographic assay with mass spectrometric detection. The clearance of rocuronium at each dialysis session was calculated by measuring the ratio of plasma concentration at the end of dialysis, average duration of 6 hours, compared with that immediately before the start of dialysis, called the RR. | All subjects pharmacokinetically evaluable consisting of all participants who received a dose of sugammadex and had at least one efficacy measurement | Posted | Mean | Standard Deviation | Reduction Ratio | Up to Day 7 |
|
|
|
| Primary | Rate of Clearance of Sugammadex From Blood | Starting on Day 1 dialysis was performed on four separate occasions using a Fresenius 40008H hemodialyzer, with a hemodiafilter standard helixone membrane FX 600. Blood samples were collected from ports in the arterial and venous tubing of the dialyzer before, during and after an average of 6 hours of hemodialysis. The concentrations of sugammadex were determined using a liquid chromatographic assay with mass spectrometric detection. The clearance rate from blood at each dialysis session was assessed by averaging across all available collection time points. | All subjects pharmacokinetically evaluable consisting of all participants who received a dose of sugammadex and had at least one efficacy measurement | Posted | Mean | Standard Deviation | mL/min | Up to day 7 |
|
|
|
| Primary | Rate of Clearance of Rocuronium From Blood | Starting on Day 1 dialysis was performed on four separate occasions using a Fresenius 40008H hemodialyzer, with a hemodiafilter standard helixone membrane FX 600. Blood samples were collected from ports in the arterial and venous tubing of the dialyzer before, during and after an average of 6 hours of hemodialysis. The concentrations of rocuronium were determined using a liquid chromatographic assay with mass spectrometric detection. The clearance rate from blood at each dialysis session was assessed by averaging across all available collection time points. | All subjects pharmacokinetically evaluable consisting of all participants who received a dose of sugammadex and had at least one efficacy measurement | Posted | Mean | Standard Deviation | mL/min | Up to Day 7 |
|
|
|
| Primary | Rate of Clearance of Sugammadex From Dialysate | Starting on Day 1 dialysis was performed on four separate occasions using a Fresenius 40008H hemodialyzer, with a hemodiafilter standard helixone membrane FX 600. Dialysate samples were collected from a port in the outflow of the dialyzer before, during and after an average of 6 hours of hemodialysis. The concentrations of sugammadex were determined using a liquid chromatographic assay with mass spectrometric detection. The clearance rate from dialysate at each dialysis session was assessed by averaging across all available collection time points.The data from the fourth dialysis are not presented as they were not calculable. | All subjects pharmacokinetically evaluable consisting of all participants who received a dose of sugammadex and had at least one efficacy measurement | Posted | Mean | Standard Deviation | mL/min | Up to day 7 |
|
|
|
| Primary | Rate of Clearance of Rocuronium From Dialysate | Starting on Day 1 dialysis was performed on four separate occasions using a Fresenius 40008H hemodialyzer, with a hemodiafilter standard helixone membrane FX 600. Dialysate samples were collected from a port in the outflow of the dialyzer before, during and after an average of 6 hours of hemodialysis. The concentrations of rocuronium were determined using a liquid chromatographic assay with mass spectrometric detection. The clearance rate from dialysate at each dialysis session was assessed by averaging across all available collection time points. | All subjects pharmacokinetically evaluable consisting of all participants who received a dose of sugammadex and had at least one efficacy measurement | Posted | Mean | Standard Deviation | mL/min | Up to Day 7 |
|
|
|
| 2 |
| 6 |
| 6 |
| 6 |
| Intestinal ischaemia | Gastrointestinal disorders | MedDRA 12.1 |
|
| Hepatic failure | Hepatobiliary disorders | MedDRA 12.1 |
|
| Pulmonary haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 |
|
| Arrhythmia | Cardiac disorders | MedDRA 12.1 |
|
| Cardiac failure | Cardiac disorders | MedDRA 12.1 |
|
| Constipation | Gastrointestinal disorders | MedDRA 12.1 |
|
| Hepatic failure | Hepatobiliary disorders | MedDRA 12.1 |
|
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA 12.1 |
|
| Post procedural infection | Infections and infestations | MedDRA 12.1 |
|
| Staphylococcal infection | Infections and infestations | MedDRA 12.1 |
|
| Urinary tract infection | Infections and infestations | MedDRA 12.1 |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 12.1 |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 12.1 |
|
| Restlessness | Psychiatric disorders | MedDRA 12.1 |
|
| Haematuria | Renal and urinary disorders | MedDRA 12.1 |
|
| Decubitis ulcer | Skin and subcutaneous tissue disorders | MedDRA 12.1 |
|
| Subcutaneous emphysema | Skin and subcutaneous tissue disorders | MedDRA 12.1 |
|
In case a proposed publication contains reference to an invention owned by the sponsor or to which the sponsor otherwise has rights, the sponsor may request a reasonable suspension of the publication.
| D003912 |
| Dextrins |
| D013213 | Starch |
| D005936 | Glucans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D000732 | Androstanols |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| Title | Measurements |
|---|---|
|
| 2 minutes post-sugammadex |
|
| 5 minutes post-sugammadex |
|
| 10 minutes post-sugammadex |
|
| 30 minutes post-sugammadx |
|
| Post-anesthetic |
|
| Title | Measurements |
|---|---|
|
| 2 minutes post-sugammadex |
|
| 5 minutes post-sugammadex |
|
| 10 minutes post-sugammadex |
|
| 30 minutes post-sugammadex |
|
| Post-anesthetic |
|
| Title | Measurements |
|---|---|
|
| 2 minutes post-sugammadex |
|
| 5 minutes post-sugammadex |
|
| 10 minutes post-sugammadex |
|
| 30 minutes post-sugammadex |
|
| Post-anesthetic |
|
| Title | Measurements |
|---|---|
|
| Fourth Dialysis (n=4) |
|
| Title | Measurements |
|---|---|
|
| Fourth Dialysis (n=4) |
|
| Title | Measurements |
|---|---|
|
| Fourth Dialysis (n=3) |
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Fourth Dialysis (n=4) |
|