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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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A prospective blinded randomized clinical trial to compare time to extubation using Sugammadex versus Neostigmine/glycopyrrolate as reversal agents after use of neuromuscular blockade agents in an outpatient bronchoscopy suite.
This research study will have the design of a blinded randomized clinical trial. The pharmacist will be blinded to the study medication given. The anesthesia provider cannot be blinded because he/she will need to determine the proper dose and timing of the neuromuscular blocker reversal medication (the study medications) given at the end of the procedure. The study will recruit 80 patients coming to Temple University Hospital for an outpatient bronchoscopy biopsy procedure that requires general anesthesia with neuromuscular blockade. Rocuronium will be the neuromuscular blockade medication given in this study. Inclusion criteria for these patients will include those age >18 who have a diagnosis of chronic obstructive pulmonary disease (COPD) and/or idiopathic lung disease (ILD) and who require medical treatment for the same; these patients will have American society of anesthesiology physical status (ASA PS) 3-4 based on their pulmonary disease alone.The patients will then be randomly assigned to one of two study arms (40 per arm). Patients in one arm of the study will receive Sugammadex and patients in the other arm will receive neostigmine/glycopyrrolate for reversal of neuromuscular blockade. Due to the nature of bronchoscopy for biopsy, the depth of anesthesia at the end of the case will be difficult to predict; the length of the cases may vary some (although most will be approximately one hour), and patients' metabolism of neuromuscular blocking agents is very much dependent on their personal medication regimens and liver function. Each patient's depth of neuromuscular blockade will be followed using the TwitchView monitor, a commercially available, an electromyography (EMG) based monitor. The TwitchView measures muscle response to delivered electrical stimuli (2Hz) which are sent in sets of 4X0.5 seconds apart (most commonly). The muscles controlled by the ulnar nerve will be followed during this study. Return of muscle strength after reversal agents are given is considered complete when the ratio of the strength of the response to the fourth electrical stimulus to the first stimulus is 0.9. Multiple time points will be recorded, including train of four measurement (TOF) every 5 minutes during the procedure, time and TOF at the end of the procedure, time of reversal medication dosing, time of TOF>0.9 and time of extubation. Reversal medication will be given as soon as each patient's procedure is complete and the patient meets appropriate criteria for reversal for each respective medication. Comparison of the data from the two arms of the study will then be made.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sugammadex | Active Comparator | Patients in this arm of the study will receive Sugammadex as the drug used to reverse neuromuscular blockade. |
|
| Neostigmine/Glycopyrrolate | Active Comparator | Patients in this arm of the study will receive Neostigmine/Glycopyrrolate as the drugs used to reverse neuromuscular blockade |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| neostigmine/glycopyrrolate | Drug | neuromuscular blockade reversal agents |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Minutes to Return of Baseline Muscle Tone | number of minutes from reversal dose to Train of Four (TOF) >0.9 indicating full reversal of neuromuscular blockade agent | 1-20 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Minutes to Extubation | number of minutes from Train of Four (TOF) >0.9 to extubation of the patient | 1-30 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ellen Hauck, DO PhD | Lewis Katz School of Medicine at Temple University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Temple University Hospital | Philadelphia | Pennsylvania | 19140 | United States |
Only deidentified data from the study will be made available to other researchers
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| ID | Title | Description |
|---|---|---|
| FG000 | Sugammadex | Patients in this arm of the study will receive Sugammadex as the drug used to reverse neuromuscular blockade. sugammadex: neuromuscular blockade reversal agent |
| FG001 | Neostigmine/Glycopyrrolate | Patients in this arm of the study will receive Neostigmine/Glycopyrrolate as the drugs used to reverse neuromuscular blockade neostigmine/glycopyrrolate: neuromuscular blockade reversal agents |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Sugammadex | Patients in this arm of the study will receive Sugammadex as the drug used to reverse neuromuscular blockade. sugammadex: neuromuscular blockade reversal agent |
| BG001 | Neostigmine/Glycopyrrolate |
| 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 | Number of Minutes to Return of Baseline Muscle Tone | number of minutes from reversal dose to Train of Four (TOF) >0.9 indicating full reversal of neuromuscular blockade agent | Posted | Mean | Standard Deviation | minutes | 1-20 minutes |
|
Adverse Event data was collected over the entire period of the study. 2 years and 3 months.
The clinicaltrials.gov definition for Adverse Events or Serious Adverse Events was followed for this study. The definition can be found below:
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
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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 | Sugammadex | Patients in this arm of the study will receive Sugammadex as the drug used to reverse neuromuscular blockade. sugammadex: neuromuscular blockade reversal agent |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ellen Hauck | Temple University Hospital | 2674438719 | ellen.hauck@tuhs.temple.edu |
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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 | May 19, 2023 | Feb 13, 2024 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D008171 | Lung Diseases |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
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| ID | Term |
|---|---|
| D009388 | Neostigmine |
| D006024 | Glycopyrrolate |
| D000077122 | Sugammadex |
| ID | Term |
|---|---|
| D050338 | Phenylammonium Compounds |
| D000644 | Quaternary Ammonium Compounds |
| D000588 | Amines |
| D009930 | Organic Chemicals |
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Study groups will be treated equally except for delivery of the neuromuscular blockade reversal medication
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Medications will be provided by Merck, Sharp & Dohme Corp and will be delivered to the inpatient pharmacy in such a way as to blind the pharmacist. Patients will also not know which medication they are receiving
| sugammadex | Drug | neuromuscular blockade reversal agent |
|
|
Patients in this arm of the study will receive Neostigmine/Glycopyrrolate as the drugs used to reverse neuromuscular blockade
neostigmine/glycopyrrolate: neuromuscular blockade reversal agents
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
|
| Secondary | Number of Minutes to Extubation | number of minutes from Train of Four (TOF) >0.9 to extubation of the patient | Posted | Mean | Standard Deviation | minutes | 1-30 minutes |
|
|
|
| 0 |
| 28 |
| 0 |
| 28 |
| 0 |
| 28 |
| EG001 | Neostigmine/Glycopyrrolate | Patients in this arm of the study will receive Neostigmine/Glycopyrrolate as the drugs used to reverse neuromuscular blockade neostigmine/glycopyrrolate: neuromuscular blockade reversal agents | 0 | 30 | 0 | 30 | 0 | 30 |
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| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009861 |
| Onium Compounds |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D047408 | gamma-Cyclodextrins |
| D003505 | Cyclodextrins |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D003912 | Dextrins |
| D013213 | Starch |
| D005936 | Glucans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |