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Investigation of Sugammadex in Outpatient Urological Procedures

Primary Purpose

Malignant Neoplasms of Urinary Tract, Bladder Cancer

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Rocuronium
Sugammadex
Neostigmine
Glycopyrrolate
Sponsored by
M.D. Anderson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Malignant Neoplasms of Urinary Tract focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • University of Texas MD Anderson Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Sugammadex

Standard of Care - Neostigmine/Glycopyrrolate

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
May 1, 2017
Last Updated
September 2, 2020
Sponsor
M.D. Anderson Cancer Center
Collaborators
Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT03138967
Brief Title
Investigation of Sugammadex in Outpatient Urological Procedures
Official Title
A Phase IV Investigation of Sugammadex in Outpatient Urological Procedures
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
September 18, 2017 (Actual)
Primary Completion Date
September 1, 2018 (Actual)
Study Completion Date
November 24, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center
Collaborators
Merck Sharp & Dohme LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malignant Neoplasms of Urinary Tract, Bladder Cancer
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

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sugammadex
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard of Care - Neostigmine/Glycopyrrolate
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Rocuronium
Other Intervention Name(s)
Rocuronium Bromide, Zemuron
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Sugammadex
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Neostigmine
Intervention Description
70 mcg/kg by vein to reverse the muscle relaxation.
Intervention Type
Drug
Intervention Name(s)
Glycopyrrolate
Intervention Description
14 mcg/kg by vein to reverse the muscle relaxation.
Primary Outcome Measure Information:
Title
Muscle Recovery Time
Description
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
Secondary Outcome Measure Information:
Title
PostOperative Complications
Description
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
Title
Overall Recovery Time
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Farzin Goravanchi, DO
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Texas MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.mdanderson.org
Description
University of Texas MD Anderson Cancer Center Website

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Investigation of Sugammadex in Outpatient Urological Procedures

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