Sugammadex vs Neostigmine/Glycopyrrolate on Urinary Retention After Spine Surgery

Study Overview
=================
Brief Summary
-----------------
This is an active-comparator controlled study to evaluate the effect of sugammadex compared to neostigmine/glycopyrrolate for reversal of rocuronium on the incidence of urinary retention after subjects undergo elective ambulatory spine surgery.

Detailed Description
-----------------
Subjects requiring elective ambulatory posterior lumbar laminectomy, will receive either an intravenous infusion bolus of Sugammadex (2 mg/kg dosed by actual body weight) or intravenous infusion bolus of Neostigmine (50 μg/kg, up to 5 mg maximum dose) plus Glycopyrrolate (10 μg/kg, up to 1 mg maximum dose). Additionally, all subjects will receive hospital standard of care therapy for their surgery and hospital stay.

Official Title
-----------------
A Double-blind, Randomized, Parallel Group Study to Compare Rocuronium Reversal With Sugammadex (Bridion®) Versus Neostigmine/Glycopyrrolate and the Incidence of Urinary Retention After Elective Ambulatory Posterior Lumbar Laminectomy

Conditions
-----------------
Spine Surgery, Reversal of Neuromuscular Blockade, Urinary Retention Postoperative

Intervention / Treatment
-----------------
* Drug: Sugammadex
* Drug: Neostigmine
* Drug: Glycopyrrolate
* Drug: Rocuronium


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 18 years ASA Physical Status I-III Exclusion Criteria: Inability to obtain written informed consent Allergy to medications used in the protocol Known or suspected neuromuscular disorders Significant renal disease with a serum creatinine ≥ 2 mg/dL Significant liver disease A family history of malignant hyperthermia History of genitourinary surgery, cancer, or radiation within the last year Currently prescribed urological medications or diuretics BPH or symptoms of BPH (interrupted or weak urine stream or wake up to urinate more than two times per night) History or diagnosis of urinary incontinence or urinary retention History of PONV with use of scopolamine Use of Foley catheter pre- or intra- operatively Perioperative medications that influence micturition (e.g., diuretics or intraoperative anticholinergic medication use other than NMB reversal)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sugammadex 2 mg/kg<br>Sugammadex 2 mg/kg administered as a single intravenous (IV) dose. | Drug: Sugammadex<br>* Sugammadex will be used to reverse rocuronium neuromuscular blockade (NMB). Dose will be according to participant actual body weight.<br>* Other names: MK-8616;Drug: Rocuronium<br>* To achieve NMB, participants will receive the steroidal neuromuscular blocking agent Rocuronium Bromide administered via IV infusion and dosed according to participant actual body weight. It will be used per label to maintain muscle relaxation as an adjunct to general anesthesia.<br>* Other names: Rocuronium Bromide;|
| Active Comparator: Neostigmine + Glycopyrrolate<br>Neostigmine 50 μg/kg (up to 5 mg maximum dose) plus glycopyrrolate 10 μg/kg (up to 1 mg maximum dose) administered as a single IV dose. | Drug: Neostigmine<br>* Neostigmine will be used to reverse rocuronium NMB. Dose will be according to participant actual body weight.<br>* Other names: Bloxiverz;Drug: Glycopyrrolate<br>* Glycopyrrolate will be co-administered with neostigmine during reversal of rocuronium NMB. Dose will be according to participant actual body weight.<br>* Other names: Glycopyrrolate injection, USP;Drug: Rocuronium<br>* To achieve NMB, participants will receive the steroidal neuromuscular blocking agent Rocuronium Bromide administered via IV infusion and dosed according to participant actual body weight. It will be used per label to maintain muscle relaxation as an adjunct to general anesthesia.<br>* Other names: Rocuronium Bromide;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of urinary retention | The difference between sugammadex and neostigmine/glycopyrrolate on the incidence of urinary retention defined as no void more than 6 hours after posterior lumbar spine surgery in ambulatory/short stay patients. | Up to 6 hours after administration of study intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Micturition | Between patients who received sugammadex and neostigmine/glycopyrrolate. To compare actual times of micturition we will analyze the proportion of patients (percentages) voided at 6, 9, 12 and 24 hours. | Up to 1 day after administration of study intervention | 
| Bladder urine volume | Between patients who received sugammadex and neostigmine/glycopyrrolate. To compare bladder urine volumes in milliliters (mL) we will perform bladder ultrasound scan at 6 hours postoperatively if patients did not void. | Up to 6 hours after administration of study intervention | 
| Urinary retention symptoms | Between patients who received sugammadex and neostigmine/glycopyrrolate. To compare urinary retention symptoms, we will administer a questionnaire at 6 hours postoperatively and on postoperative day 1. | Up to 1 day after administration of study intervention | 
| Bladder catheterization | Between patients who received sugammadex and neostigmine/glycopyrrolate. To compare need for bladder catheterization (straight or Foley). | Up to 1 Day after administration of study intervention | 
| Length of hospital stay | Between patients who received sugammadex and neostigmine/glycopyrrolate. To compare length of hospital stay. | Up to 7 Days after administration of study intervention | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cholinesterase Inhibitors, Urinary retention, Spine surgery, Sugammadex, Neostigmine, Neuromuscular blockade, Neuromuscular blockade reversal, Cholinergic Agents, Physiological Effects of Drugs, Parasympathomimetic, Autonomic Agents