Investigation of Sugammadex in Outpatient Urological Procedures



Status:Recruiting
Conditions:Cancer, Cancer, Bladder Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:2/2/2018
Start Date:September 18, 2017
End Date:September 2020
Contact:Farzin Goravanchi, DO
Email:CR_Study_Registration@mdanderson.org
Phone:713-291-1163

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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, participant's 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 participant breathe. Sugammadex and other
standard drugs reverse the effect of the muscle relaxation drugs, allowing participant to
breathe on participant's own after the operation.

Study Groups:

If participant agrees to take part in this study, participant 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 participant is in Group 1, participant will receive sugammadex to reverse the muscle
relaxation.

- If participant is in Group 2, participant will receive the standard of care
(neostigmine/glycopyrrolate) to reverse the muscle relaxation.

Participant and the surgeon will not know which group participant has been assigned to.
However, the anesthesiologist and study staff will know.

Study Procedures:

Before the cystoscopy, researchers will collect participant's basic information and medical
history. Researchers will take participant's vital signs and the anesthesiologist will
perform routine assessments. This will take about 30-60 minutes to complete.

Before the cystoscopy, participant will be given rocuronium to relax participant's muscles.
After the procedure, participant will receive either sugammadex or the standard of care to
reverse the relaxation.

After participant is extubated (the tube is removed from participant's throat), researchers
will assess how fast the relaxation drugs the anesthesiologist gave participant wears off
(stop working), using a small monitoring device that will be attached to participant's wrist.
This is the only research test that will be done right after surgery.

If participant is still in the hospital 1 day after the cystoscopy, a member of the staff
will ask participant the series of questions. If participant has been sent home, participant
will be called and participant will complete them by phone.

Researchers will also collect information about participant's cystoscopy procedure and
recovery from participant's medical record. This collection will continue for up to 1 week
after surgery.

Length of Study:

Participant will be on study for up to 1 week after the cystoscopy. If participant is unable
to have the procedure performed, participant 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.

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)
We found this trial at
1
site
1515 Holcombe Blvd
Houston, Texas 77030
 713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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