Investigation of Sugammadex in Outpatient Urological Procedures
A Phase IV Investigation of Sugammadex in Outpatient Urological Procedures
1 other identifier
interventional
54
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Sep 2017
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 1, 2017
CompletedFirst Posted
Study publicly available on registry
May 3, 2017
CompletedStudy Start
First participant enrolled
September 18, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2018
CompletedResults Posted
Study results publicly available
July 26, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
November 24, 2019
CompletedSeptember 22, 2020
September 1, 2020
12 months
May 1, 2017
June 27, 2019
September 2, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (2)
PostOperative Complications
Post-operatively, up to 7 days
Overall Recovery Time
Up to 3 hours after end of surgery
Study Arms (2)
Sugammadex
EXPERIMENTALParticipants 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 COMPARATORParticipants 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.
Interventions
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.
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.
70 mcg/kg by vein to reverse the muscle relaxation.
14 mcg/kg by vein to reverse the muscle relaxation.
Eligibility Criteria
You may qualify if:
- 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)
- Male or Females who are \>= 18 years of age
- Classified by the American Society of Anesthesiologists (ASA) as Class I - IV
- Candidate for use of laryngeal mask airway (LMA)
- Able to give consent
You may not qualify if:
- Severe renal impairment as measured eGFR less than 30 per institutional laboratory.
- Females who are pregnant or might be pregnant or are breast-feeding.
- Females who have been diagnosed with breast cancer and currently taking Toremifene
- Is known or suspected to have significant hepatic dysfunction, with AST \& ALT 3 times above UNL per institutional laboratory.
- Is known or suspected to have a (family) history of malignant hyperthermia
- Is known or suspected to have an allergy to opioids, muscle relaxants or other medications used during general anesthesia
- Is known or suspected to have neuromuscular disorders (ex: myasthenia gravis)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- M.D. Anderson Cancer Centerlead
- Merck Sharp & Dohme LLCcollaborator
Study Sites (1)
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Farzin Goravanchi / Anesthesiology & Perioperative Medicine
- Organization
- UT MD Anderson Cancer Center
Study Officials
- PRINCIPAL INVESTIGATOR
Farzin Goravanchi, DO
M.D. Anderson Cancer Center
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 1, 2017
First Posted
May 3, 2017
Study Start
September 18, 2017
Primary Completion
September 1, 2018
Study Completion
November 24, 2019
Last Updated
September 22, 2020
Results First Posted
July 26, 2019
Record last verified: 2020-09