Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Urinary Bladder Neoplasms

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Urinary Bladder Diseases

Urologic Diseases

Male Urogenital Diseases

All Drugs and Chemicals

Anticonvulsants

Adjuvants, Anesthesia

Central Nervous System Depressants

Rocuronium

Neostigmine

Bromides

Glycopyrrolate

Neuromuscular Nondepolarizing Agents

Neuromuscular Blocking Agents

Cholinesterase Inhibitors

Enzyme Inhibitors

Cholinergic Agents

Neurotransmitter Agents

Anesthetics

Muscarinic Antagonists

Cholinergic Antagonists

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.

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.

Sugammadex

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

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

Farzin Goravanchi, DO

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 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.

Investigation of Sugammadex in Outpatient Urological Procedures

A Phase IV Investigation of Sugammadex in Outpatient Urological Procedures

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.

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.

To determine if Sugammadex can improve overall recovery time, measured by time from end of surgery to the time patient met Discharge Criteria.

Merck Sharp & Dohme LLC

M.D. Anderson Cancer Center

Sugammadex will be administered as a single bolus, intravenous injection. The amount used is based on the patient's weight. A dose of 4 mg/kg will be used if recovery has reached at least 1-2 post-tetanic counts (PTC) following Rocuronium induced blockade.

Suggamadex or Treatment Group

Neostigmine/Glycopyrrolate will be 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 70mcg/kg of neostigmine with 14 mcg/kg glycopyrrolate will be administered simultaneously over a period of one minute up to 5 mg.

Neostigime/Glycopyrrolate or Standard of Care Group

Total

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

United States

Region of Enrollment

Body Mass Index (BMI)

Dr. Farzin Goravanchi / Anesthesiology & Perioperative Medicine

Muscle Recovery Time

PostOperative Complications

Overall Recovery Time

Overall Study

Analgesics

Platelet Aggregation Inhibitors

Bupivacaine

Fentanyl

Propofol

Sevoflurane

Anesthetics, Local

Hypnotics and Sedatives

Anesthetics, Intravenous

Anesthetics, General

Analgesics, Opioid

Narcotics

Anesthetics, Inhalation

Transurethral resection of the bladder performed under spinal anesthesia.

Transurethral resection of the bladder performed under general anesthesia.

Spinal anesthesia

General anesthesia

bupivacaine

fentanyl

propofol

sevoflurane

Nina Sulen, MD

Tatjana Simurina, MD, PhD

Tatjana Simurina, MD,PhD

Tomislav Soric, MD,PhD

Transurethral resection of the bladder (TURB) is often performed as an outpatient procedure so high-quality postoperative recovery is particularly important. The aim of this study is to compare postoperative quality of recovery after spinal anesthesia (SA) and general anesthesia (GA) for transurethral resection of the bladder.

After written informed consent is obtained seventy patients aged 18-80 years, ASA (American Society of Anesthesiologists) physical status class I-III scheduled for TURB will be randomly assigned to either spinal anesthesia or general anesthesia. Spinal anesthesia will be performed with 12.5 mg of bupivacaine mixed with 25 mcg of fentanyl. General anesthesia will be performed with propofol and fentanyl and maintained with sevoflurane, without use of neuromuscular blocking agents. Quality of Recovery 40 questionnaire (QoR-40) administered before and 24 hours after surgery will be used for assessment of postoperative recovery.

Postoperative Quality of Recovery After Transurethral Resection of the Bladder

Postoperative Quality of Recovery After Transurethral Resection of the Bladder: Spinal Versus General Anesthesia

Quality of Recovery 40 questionnaire at 24 hours

Postoperative opioid consumption over 24 hours

Postoperative pain measured with visual analogue scale at 1,6 and 24 hours

Overall patient satisfaction with anesthesia measured with numerical rating scale

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Investigation of Sugammadex in Outpatient Urological Procedures	NCT03138967	Malignant Neopl... Bladder Cancer	Rocuronium Sugammadex Neostigmine Glycopyrrolate	18 Years -	M.D. Anderson Cancer Center
Postoperative Quality of Recovery After Transurethral Resection of the Bladder	NCT02534623	Urinary Bladder... Transurethral R... Postoperative R...	Spinal anesthes... General anesthe... bupivacaine fentanyl propofol sevoflurane	18 Years - 80 Years	General Hospital Zadar
Postoperative Quality of Recovery After Transurethral Resection of the Bladder	NCT02534623	Urinary Bladder... Transurethral R... Postoperative R...	Spinal anesthes... General anesthe... bupivacaine fentanyl propofol sevoflurane	18 Years - 80 Years	General Hospital Zadar
Investigation of Sugammadex in Outpatient Urological Procedures	NCT03138967	Malignant Neopl... Bladder Cancer	Rocuronium Sugammadex Neostigmine Glycopyrrolate	18 Years -	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for transurethral resection of the bladder