Investigation of Sugammadex in Outpatient Urological Procedures

A Phase IV Investigation of Sugammadex in Outpatient Urological Procedures

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.

Study Overview

• Status: Completed
• Conditions: Bladder Cancer; Malignant Neoplasms of Urinary Tract
• Intervention / Treatment: Drug: Rocuronium; Drug: Sugammadex; Drug: Neostigmine; Drug: Glycopyrrolate

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.

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • University of Texas MD Anderson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Drug: Rocuronium; 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.; Other Names: Zemuron; Rocuronium Bromide; Drug: Sugammadex; 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.
Active Comparator: Standard of Care - Neostigmine/Glycopyrrolate; 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.	Drug: Rocuronium; 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.; Other Names: Zemuron; Rocuronium Bromide; Drug: Neostigmine; 70 mcg/kg by vein to reverse the muscle relaxation.; Drug: Glycopyrrolate; 14 mcg/kg by vein to reverse the muscle relaxation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Collaborators: Merck Sharp & Dohme LLC
• Investigators: Principal Investigator: Farzin Goravanchi, DO, M.D. Anderson Cancer Center

Publications and helpful links

Helpful Links

• University of Texas MD Anderson Cancer Center Website

Study record dates

Study Major Dates

• Study Start (Actual): September 18, 2017
• Primary Completion (Actual): September 1, 2018
• Study Completion (Actual): November 24, 2019

Study Registration Dates

• First Submitted: May 1, 2017
• First Submitted That Met QC Criteria: May 1, 2017
• First Posted (Actual): May 3, 2017

Study Record Updates

• Last Update Posted (Actual): September 22, 2020
• Last Update Submitted That Met QC Criteria: September 2, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: Bladder cancer; TURB; Rocuronium; Sugammadex; Neostigmine; Glycopyrrolate; Malignant neoplasms of urinary tract; Outpatient bladder procedures; Outpatient cystoscopy procedure; Transurethral resection of the bladder; Rocuronium Bromide; Zemuron
• Additional Relevant MeSH Terms: Urogenital Neoplasms; Neoplasms by Site; Urologic Diseases; Urinary Bladder Diseases; Neoplasms; Urinary Bladder Neoplasms; Urologic Neoplasms; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Enzyme Inhibitors; Adjuvants, Anesthesia; Anticonvulsants; Neuromuscular Agents; Cholinesterase Inhibitors; Neuromuscular Nondepolarizing Agents; Neuromuscular Blocking Agents; Parasympathomimetics; Glycopyrrolate; Bromides; Rocuronium; Neostigmine
• Other Study ID Numbers: 2015-1007

Drug and device information, study documents

• 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