Investigation of Sugammadex in Outpatient Urological Procedures

NCT ID: NCT03138967

Last Updated: 2020-09-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-18
• Study Completion Date: 2019-11-24

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.

Conditions

Malignant Neoplasms of Urinary Tract; Bladder Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Rocuronium

Intervention Type: DRUG

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

Intervention Type: DRUG

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

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.

Group Type: ACTIVE_COMPARATOR

Rocuronium

Intervention Type: DRUG

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.

Neostigmine

Intervention Type: DRUG

70 mcg/kg by vein to reverse the muscle relaxation.

Glycopyrrolate

Intervention Type: DRUG

14 mcg/kg by vein to reverse the muscle relaxation.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Neostigmine

70 mcg/kg by vein to reverse the muscle relaxation.

Intervention Type: DRUG

Glycopyrrolate

14 mcg/kg by vein to reverse the muscle relaxation.

Intervention Type: DRUG

Other Intervention Names

Rocuronium Bromide; Zemuron

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: collaborator

M.D. Anderson Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Farzin Goravanchi, DO

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

http://www.mdanderson.org

University of Texas MD Anderson Cancer Center Website

Other Identifiers

2015-1007

Identifier Type: -

Identifier Source: org_study_id