Comparison of reversal of neuromuscular blockade with sugammadex versus neostigmine plus glycopyrolate in patients undergoing burn surgery

Sep 25, 2026

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University of Kansas Medical Center Department of Anesthesiology protocol comparing sugammadex versus neostigmine plus glycopyrolate for reversal of neuromuscular blockade in burn patients undergoing surgery with rocuronium. Rationale addresses burn-related hypermetabolism and altered neuromuscular junction physiology, which can change dosing and prolong recovery with neostigmine. The study will assess time to recovery of muscle function and endotracheal extubation, documenting effectiveness and safety, with defined primary and secondary hypotheses and clear inclusion/exclusion criteria.

LanguageEnglish

CategoryGeneral

FormatPDF

Pages12

Reading Time4 min

AccessFree to download

Background

Purpose of Study

Hypotheses

Inclusion and Exclusion Criteria

University of Kansas Medical Center – Department of Anesthesiology PROTOCOL TITLE: Comparison of reversal of neuromuscular blockade with Sugammadex versus neostigmine plus glycopyrolate in patients undergoing burn surgery. PRINCIPAL INVESTIGATOR: Name: Anthony L Kovac MD Department: Anesthesiology Telephone Number: 913-588-6670 Email Address: akovac@kumc.e du Name: Dhaval Bhavsar MD Department: Plastic Surgery Telephone Number: 913-588-2000 Email Address: [dbhavsar@kumc.edu](dbhavsar@kumc.edu) SUB-INVESTIGATORS: Aaron LacKamp MD Gina Hendren MD Jay Nachtigal MD Dhaval Bhavsar, MD Jennifer Hansen MD IND or IDE: (provided by FDA) PILOT STUDY VERSION NUMBER: 5 VERSION DATE: 7-DEC-2020 BACKGROUND: Muscle relaxants are commonly used to facilitate endotracheal intubation. To ensure patients are strong enough to breathe properly at the end of surgery, a reversal medication such as sugammadex or neostigmine plus glycopyrolate is commonly used to reverse a muscle relaxant such as rocuronium. Glycopyrolate is an anticholinergic medication used to counter the bradycardia caused by neostigmine. Sugammadex (Bridion) is a relatively new muscle relaxant reversal medication that received FDA approval in the USA in December 2015. Reversal of neuromuscular blockade with these two medications is standard practice in the USA and both medications are commonly used at the University of Kansas Medical Center (KUMC) . The time to complete reversal with neostigmine can be long and unpredictable ranging from 20 to 40 minutes. The reversal action of sugammadex is much faster (2 to 3 minutes) than neostigmine plus glycopyrolate. Burn patients also undergo ahypermetabolic stage as a result of their burn injury which can affect the metabolism of medications. A descriptive case series provided promising results administering sugammadex for burn patients (Rodriguez Sanchez [et.al. 2015](et.al. 2015) ) . Sugammadex and neostigmine plus glycopyrolate are currently used in burn patient surgery for muscle relaxant reversal at KUMC. However, to our knowledge, there are no published randomized controlled trials evaluating sugammadex for burn patients who require surgery fordebridement and skin grafting. Following the first day of their injury, burn patients requiring surgery for debridement and skin grafting under general anesthesia with neuromuscular block (NMB) paralysis can only receive muscle relaxation with a non-depolarizing muscle relaxant such as rocuronium. This is because depolarizing muscle relaxants such as succinylcholine cause muscle fasciculations resulting in an increased release of potassium from the muscle neuromuscular junction which has been altered by burn injury. Use of succinylcholine is contraindicated one day or more following burn injury and instead a non-depolarizing muscle relaxant such as rocuronium which does not cause muscle fasciculations is used (Han [et.al. 2004](et.al. 2004) ) . Burn injury causes a proliferation of acetylcholine receptors on the muscle membrane under the burn causing increased resistance to the muscle relaxant paralyzing effects of a nondepolarizing agent. This, plus the fact that burn patients also have an increased volume of distribution, clinically requires a larger dose of the non-depolarizing muscle relaxant to be administered to achieve the desired muscle relaxation effect. Thus, burn patients have the appearance of being resistant to neuromuscular blockade (Han [et.al. 2009](et.al. 2009) ) . Following initial burn injury, burn patients undergo a hypermetabolic phase with an increase in heart rate, blood pressure and cardiac output. These patients appear to require a larger dose of nondepolarizing muscle relaxants PURPOSE OF STUDY: Following reversal of a moderate level of neuromuscular block, this study will investigate whether or not there is a difference in the time to recovery of muscle function and endotracheal extubation following muscle relaxant reversal b

FAQs

What is the primary outcome being tested in this study?

The primary hypothesis is that, in burn patients, the time to neuromuscular reversal to a 90% Train of Four (TOF) response with sugammadex is more rapid than with neostigmine plus glycopyrolate.

What secondary outcomes are evaluated?

Secondary outcomes include the time to endotracheal extubation and the time to discharge from the operating room after reversal with sugammadex versus neostigmine plus glycopyrolate.

Who can participate, and who is excluded?

Inclusion requires adult inpatients (18–74) undergoing burn surgery under general anesthesia with an unburned upper or lower extremity. Exclusions include age outside 18–74, renal insufficiency or failure, hypersensitivity to sugammadex, and liver impairment or relevant neuromuscular degenerative disease or dependence on drugs or alcohol.

Sep 25, 2026

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