Bladder Cancer, Malignant Neoplasms of Urinary Tract
Conditions
Keywords
Malignant neoplasms of urinary tract, Bladder cancer, Outpatient bladder procedures, Outpatient cystoscopy procedure, Transurethral resection of the bladder, TURB, Rocuronium, Rocuronium Bromide, Zemuron, Sugammadex, Neostigmine, Glycopyrrolate
Brief summary
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: * If you are in Group 1, you will receive sugammadex to reverse the muscle relaxation. * If you are in Group 2, you will receive the standard of care (neostigmine/glycopyrrolate) to reverse the muscle relaxation. 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.
Detailed description
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.
Interventions
DRUGRocuronium
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.
DRUGSugammadex
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.
DRUGNeostigmine
70 mcg/kg by vein to reverse the muscle relaxation.
DRUGGlycopyrrolate
14 mcg/kg by vein to reverse the muscle relaxation.
Sponsors
Merck Sharp & Dohme LLC
M.D. Anderson Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Is scheduled to undergo cystoscopy with bladder resection procedure under general anesthesia requiring neuromuscular relaxation using rocuronium bromide to secure airway and requiring neuromuscular reversal at The University of Texas MD Anderson Cancer Center - Mays Clinic (ACB-outpatient) 2. Male or Females who are \>= 18 years of age 3. Classified by the American Society of Anesthesiologists (ASA) as Class I - IV 4. Candidate for use of laryngeal mask airway (LMA) 5. Able to give consent
Exclusion criteria
1. Severe renal impairment as measured eGFR less than 30 per institutional laboratory. 2. Females who are pregnant or might be pregnant or are breast-feeding. 3. Females who have been diagnosed with breast cancer and currently taking Toremifene 4. Is known or suspected to have significant hepatic dysfunction, with AST & ALT 3 times above UNL per institutional laboratory. 5. Is known or suspected to have a (family) history of malignant hyperthermia 6. Is known or suspected to have an allergy to opioids, muscle relaxants or other medications used during general anesthesia 7. Is known or suspected to have neuromuscular disorders (ex: myasthenia gravis)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Muscle Recovery Time | Intraoperatively, up to 3 hours | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PostOperative Complications | Post-operatively, up to 7 days | 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. |
| Overall Recovery Time | Up to 3 hours after end of surgery | To determine if Sugammadex can improve overall recovery time, measured by time from end of surgery to the time patient met Discharge Criteria. |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 26 |
| 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. | 28 |
| Total | 54 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 0 | 1 |
| Overall Study | Physician Decision | 1 | 3 |
Baseline characteristics
| Characteristic | Suggamadex or Treatment Group | Neostigime/Glycopyrrolate or Standard of Care Group | Total |
|---|---|---|---|
| Age, Continuous | 67.1923 Years STANDARD_DEVIATION 8.04 | 71.6071 Years STANDARD_DEVIATION 8.7235 | 69.48 Years STANDARD_DEVIATION 8.61 |
| Body Mass Index (BMI) | 27.9385 kg/m^2 STANDARD_DEVIATION 5.7725 | 28.7214 kg/m^2 STANDARD_DEVIATION 4.766 | 28.34 kg/m^2 STANDARD_DEVIATION 5.24 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 5 Participants | 8 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 22 Participants | 21 Participants | 43 Participants |
| Region of Enrollment United States | 26 participants | 28 participants | 54 participants |
| Sex: Female, Male Female | 8 Participants | 3 Participants | 11 Participants |
| Sex: Female, Male Male | 18 Participants | 25 Participants | 43 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 1 / 25 |
| other Total, other adverse events | 5 / 25 | 6 / 25 |
| serious Total, serious adverse events | 0 / 25 | 1 / 25 |
Outcome results
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.
Time frame: Intraoperatively, up to 3 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Suggamadex or Treatment Group | Muscle Recovery Time | 2 minutes | Standard Deviation 0.6455 |
| Neostigime/Glycopyrrolate or Standard of Care Group | Muscle Recovery Time | 9.24 minutes | Standard Deviation 7.8755 |
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.
Time frame: Up to 3 hours after end of surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Suggamadex or Treatment Group | Overall Recovery Time | 2.0847 hours | Standard Deviation 0.8742 |
| Neostigime/Glycopyrrolate or Standard of Care Group | Overall Recovery Time | 2.4727 hours | Standard Deviation 2.0447 |
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.
Time frame: Post-operatively, up to 7 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Suggamadex or Treatment Group | PostOperative Complications | 5 Participants |
| Neostigime/Glycopyrrolate or Standard of Care Group | PostOperative Complications | 7 Participants |