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BRIEF TITLE: A Phase IV Investigation of Sugammadex in Outpatient Urological Procedures

A Phase IV Investigation of Sugammadex in Outpatient Urological Procedures


  • Org Study ID: 2015-1007
  • Secondary ID:
  • NCT ID: NCT03138967
  • NCT Alias:
  • Sponsor: M.D. Anderson Cancer Center - Other
  • Source: M.D. Anderson Cancer Center

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.

Overal Status Start Date Phase Study Type
Recruiting September 18, 2017 Phase 4 Interventional

Primary Outcomes:

Primary Outcome 1 - Measure: Muscle Recovery Compared to Standard of Care (SOC)

Primary Outcome 1 - Time Frame: 7 days after surgery

Condition:

  • Malignant Neoplasms of Urinary Tract
  • Bladder Cancer

Eligibility

Criteria:
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)
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Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Official Information

Name: Farzin Goravanchi, DO

Role: Principal Investigator

Affiliation: M.D. Anderson Cancer Center

Overall Contact

Name: Farzin Goravanchi, DO

Phone: 713-291-1163

Email: CR_Study_Registration@mdanderson.org

Link: University of Texas MD Anderson Cancer Center Website

Location

Facility Status Contact
University of Texas MD Anderson Cancer Center
Houston, Texas 77030
United States
Recruiting Clinical Research Operations

CR_Study_Registration@mdanderson.org