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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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The goal of this clinical research study is to determine whether using sugammadex, given with a standard muscle relaxation drug during bladder surgeries, improves anesthesia conditions and recovery time.
During some bladder operations, your muscles must be completely relaxed. Muscle relaxation drugs cause the muscles to relax, including the respiratory muscles, and as a result artificial ventilation is needed to help you breathe. Sugammadex and other standard drugs reverse the effect of the muscle relaxation drugs, allowing you to breathe on your own after the operation.
Study Groups:
If you agree to take part in this study, you will be randomly assigned (as in the flip of a coin) to 1 of 2 study groups. This is done because no one knows if one study group is better, the same, or worse than the other group:
You and the surgeon will not know which group you have been assigned to. However, the anesthesiologist and study staff will know.
Length of Study:
You will be on study for up to 1 week after the cystoscopy. If you are unable to have the procedure performed, you may be taken off study early.
This is an investigational study. Sugammadex and neostigmine/glycopyrrolate are all FDA approved and commercially available to reverse muscle relaxation. The comparison of these drugs is investigational.
Up to 50 participants will take part in this study. All will be enrolled at MD Anderson.
Study Procedures:
Before the cystoscopy, we will collect your basic information and medical history. We will take your vital signs and the anesthesiologist will perform routine assessments. This will take about 30-60 minutes to complete.
Before the cystoscopy, you will be given rocuronium to relax your muscles. After the procedure, you will receive either sugammadex or the standard of care to reverse the relaxation.
After you are extubated (the tube is removed from your throat), we will assess how fast the relaxation drugs the anesthesiologist gave you wear off (stop working), using a small monitoring device that will be attached to your wrist. This is the only research test that will be done right after surgery.
If you are still in the hospital 1 day after the cystoscopy, a member of the staff will ask you the series of questions. If you have been sent home, you will be called and you will complete them by phone.
Researchers will also collect information about your cystoscopy procedure and recovery from your medical record. This collection will continue for up to 1 week after surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sugammadex | Experimental | Participants to have cystoscopy with bladder tumor resection. Rocuronium used to induce the neuromuscular blockade and given in a rapid sequence for endotracheal intubation at a dose of 0.45 mg/kg of Ideal Body Weight. If maintenance is needed for continued relaxation then a dose of 0.15 mg/kg of Ideal Body Weight repeated as necessary. Sugammadex administered as a single bolus, intravenous injection. The amount used is based on the patient's weight. A dose of 4 mg/kg used if recovery has reached at least 1-2 post-tetanic counts (PTC) following Rocuronium induced blockade. |
|
| Standard of Care - Neostigmine/Glycopyrrolate | Active Comparator | Participants to have cystoscopy with bladder tumor resection. Rocuronium used to induce the neuromuscular blockade and given in a rapid sequence for endotracheal intubation at a dose of 0.45 mg/kg of Ideal Body Weight. If maintenance is needed for continued relaxation then a dose of 0.15 mg/kg of Ideal Body Weight repeated as necessary. Neostigmine/Glycopyrrolate administered as a single bolus, intravenous injection. The amount used is based on the patient's weight. Once T1 is at 10% or greater, a dose of 70 mcg/kg of Neostigmine with 14 mcg/kg Glycopyrrolate administered simultaneously over a period of one minute up to 5 mg. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rocuronium | Drug | Experimental: Sugammadex Participants to have cystoscopy with bladder tumor resection. Rocuronium used to induce the neuromuscular blockade and given in a rapid sequence for endotracheal intubation at a dose of 0.45 mg/kg of Ideal Body Weight. If maintenance is needed for continued relaxation then a dose of 0.15 mg/kg of Ideal Body Weight repeated as necessary. |
| Measure | Description | Time Frame |
|---|---|---|
| Muscle Recovery Time | The primary outcome is to determine if Sugammadex can improve muscle recovery time, measured by time from administration of neuromuscular blockade reversal to train-of-four ratio of 0.9 in outpatient bladder procedures. It was assessed in the intraoperative period measuring the time from administration of reversal agent to TOF of 0.9 in minutes. | Intraoperatively, up to 3 hours |
| Measure | Description | Time Frame |
|---|---|---|
| PostOperative Complications | To determine if Sugammadex can improve post-operative complications for outpatient bladder procedures such as bladder perforation, nausea, vomiting, post-operative intubation and hospital admittance secondary to respiratory complications which was assessed uring follow ups on post-operative day 1 (POD1) and post-operative day 7 (POD7) looking for immediate postoperative complications such as bladder perforation, nausea, vomiting, postoperative intubation and hospital admittance secondary to respiratory complications and readmission within a week post-procedure for any other cause. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Farzin Goravanchi, DO | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
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| Label | URL |
|---|---|
| University of Texas MD Anderson Cancer Center Website | View source |
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Participants were screened within days of their scheduled eligible procedure. Enrolled 50 patients, 4 withdrew, we requested IRB approval to enroll 4 more to maintain statistical power. A total of 54 patients were enrolled in the study, but only 50 were assessed for the primary outcome, 1 participant died before POD-7 follow-up.
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| ID | Title | Description |
|---|---|---|
| FG000 | Suggamadex or Treatment Group | Sugammadex will be administered as a single bolus, intravenous injection. The amount used is based on the patient's weight. A dose of 4 mg/kg will be used if recovery has reached at least 1-2 post-tetanic counts (PTC) following Rocuronium induced blockade. |
| FG001 | Neostigime/Glycopyrrolate or Standard of Care Group | Neostigmine/Glycopyrrolate will be administered as a single bolus, intravenous injection. The amount used is based on the patient's weight. Once T1 is at 10% or greater, a dose of 70mcg/kg of neostigmine with 14 mcg/kg glycopyrrolate will be administered simultaneously over a period of one minute up to 5 mg. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Suggamadex or Treatment Group | Sugammadex will be administered as a single bolus, intravenous injection. The amount used is based on the patient's weight. A dose of 4 mg/kg will be used if recovery has reached at least 1-2 post-tetanic counts (PTC) following Rocuronium induced blockade. |
| BG001 |
| 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 | Muscle Recovery Time | The primary outcome is to determine if Sugammadex can improve muscle recovery time, measured by time from administration of neuromuscular blockade reversal to train-of-four ratio of 0.9 in outpatient bladder procedures. It was assessed in the intraoperative period measuring the time from administration of reversal agent to TOF of 0.9 in minutes. | Posted | Mean | Standard Deviation | minutes | Intraoperatively, up to 3 hours |
|
7 days post 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 | Suggamadex or Treatment Group | Sugammadex will be administered as a single bolus, intravenous injection. The amount used is based on the patient's weight. A dose of 4 mg/kg will be used if recovery has reached at least 1-2 post-tetanic counts (PTC) following Rocuronium induced blockade. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Stroke | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hematuria | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Farzin Goravanchi / Anesthesiology & Perioperative Medicine | UT MD Anderson Cancer Center | 713-291-1163 | fgoravan@mdanderson.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 | Oct 5, 2017 | Jun 24, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D001749 | Urinary Bladder Neoplasms |
| ID | Term |
|---|---|
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D000077123 | Rocuronium |
| D000077122 | Sugammadex |
| D009388 | Neostigmine |
| D006024 | Glycopyrrolate |
| ID | Term |
|---|---|
| D000732 | Androstanols |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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|
|
| Sugammadex | Drug | Sugammadex administered as a single bolus, intravenous injection. The amount used is based on the patient's weight. A dose of 4 mg/kg used if recovery has reached at least 1-2 post-tetanic counts (PTC) following Rocuronium induced blockade. |
|
| Neostigmine | Drug | 70 mcg/kg by vein to reverse the muscle relaxation. |
|
| Glycopyrrolate | Drug | 14 mcg/kg by vein to reverse the muscle relaxation. |
|
| Post-operatively, up to 7 days |
| Overall Recovery Time | To determine if Sugammadex can improve overall recovery time, measured by time from end of surgery to the time patient met Discharge Criteria. | Up to 3 hours after end of surgery |
| Neostigime/Glycopyrrolate or Standard of Care Group |
Neostigmine/Glycopyrrolate will be administered as a single bolus, intravenous injection. The amount used is based on the patient's weight. Once T1 is at 10% or greater, a dose of 70mcg/kg of neostigmine with 14 mcg/kg glycopyrrolate will be administered simultaneously over a period of one minute up to 5 mg. |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Race (NIH/OMB) | Count of Participants | Participants | No |
|
| Region of Enrollment | Number | participants |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
|
Neostigmine/Glycopyrrolate will be administered as a single bolus, intravenous injection. The amount used is based on the patient's weight. Once T1 is at 10% or greater, a dose of 70mcg/kg of neostigmine with 14 mcg/kg glycopyrrolate will be administered simultaneously over a period of one minute up to 5 mg. |
|
|
| Secondary | PostOperative Complications | To determine if Sugammadex can improve post-operative complications for outpatient bladder procedures such as bladder perforation, nausea, vomiting, post-operative intubation and hospital admittance secondary to respiratory complications which was assessed uring follow ups on post-operative day 1 (POD1) and post-operative day 7 (POD7) looking for immediate postoperative complications such as bladder perforation, nausea, vomiting, postoperative intubation and hospital admittance secondary to respiratory complications and readmission within a week post-procedure for any other cause. | Posted | Count of Participants | Participants | Post-operatively, up to 7 days |
|
|
|
| Secondary | Overall Recovery Time | To determine if Sugammadex can improve overall recovery time, measured by time from end of surgery to the time patient met Discharge Criteria. | Posted | Mean | Standard Deviation | hours | Up to 3 hours after end of surgery |
|
|
|
| 0 |
| 25 |
| 0 |
| 25 |
| 5 |
| 25 |
| EG001 | Neostigime/Glycopyrrolate or Standard of Care Group | Neostigmine/Glycopyrrolate will be administered as a single bolus, intravenous injection. The amount used is based on the patient's weight. Once T1 is at 10% or greater, a dose of 70mcg/kg of neostigmine with 14 mcg/kg glycopyrrolate will be administered simultaneously over a period of one minute up to 5 mg. | 1 | 25 | 1 | 25 | 6 | 25 |
| Uncontrolled Hypertension | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
|
| Laceration of penis' skin | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Urinary Tract Infection | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hematuria with Clot retention | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| IV infiltration | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
|
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| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D014570 | Urologic Diseases |
| D001745 | Urinary Bladder Diseases |
| D011083 |
| Polycyclic Compounds |
| D047408 | gamma-Cyclodextrins |
| D003505 | Cyclodextrins |
| D047028 | Macrocyclic Compounds |
| D003912 | Dextrins |
| D013213 | Starch |
| D005936 | Glucans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D050338 | Phenylammonium Compounds |
| D000644 | Quaternary Ammonium Compounds |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D009861 | Onium Compounds |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |