Study to Determine if Administration of Sugammadex Impacts Hospital Efficiency

Neuromuscular Blockade Clinical Trial

Official title:

A Randomized, Blinded-assessor, Single Center Study to Determine if Administration of Sugammadex, When Used to Reverse Deep Neuromuscular Blockade (NMB) After Open Abdominal Surgery, Impacts Hospital Efficiency

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02860507
• Other study ID #: TGH015
• Status: Completed
• Phase: Phase 4
• Start date: August 2016
• Est. completion date: February 2018

Study information

• Verified date: April 2019
• Source: University of South Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy of Sugammadex in rapidly reversing deep neuromuscular blockaded (induced by rocuronium)

Description:

Participants in the study group will receive a single bolus of Sugammadex (4.0mg/kg) prior to extubation. In the post-anesthesia care unit (PACU), a blinded safety-assessor will use the visual analog scale to clinically assess post-operative pain. Post-operative nausea and vomiting (PONV) will be assessed using a PONV rating scale every 30 minutes until PACU discharge. All patients will be monitored with continuous pulse-oximetry.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: February 2018
• Est. primary completion date: February 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients scheduled for open ventral hernia repair or open colectomy

• ASA class I-III

• 18 years and older

• Subjects with a body mass index (BMI) of <45kg/m2 and weight less than 150kg

• Subjects who have given written informed consent

Exclusion Criteria:

• Subjects with medical conditions and/or undergoing surgical procedures that are not compatible with the use of the TOF-Watch® SX (e.g., injuries to the thumbs/distal forearms, bilateral ulnar nerve damage or subjects with cardiac pacemaker

• Subjects known or suspected to have neuromuscular disorders impairing neuromuscular blockade (e.g., subjects with myasthenia gravis)

• Subjects known or suspected to have significant renal dysfunction (e.g. creatinine clearance < 30 mL.min-1

• Subjects known or suspected to have a (family)history of malignant hyperthermia; have significant hepatic dysfunction

• Subjects known or suspected to have an allergy to opiates/opioids, muscle relaxants or other medications used during general anesthesia;

• Subjects known or suspected to be hypersensitive to Sugammadex or other cyclodextrins or Rocuronium or any of its excipients

• Subjects who have a contraindication to, Rocuronium or Sugammadex

• Female subjects who are pregnant

• Morbidly obese subjects with a BMI > 45 kg/m2 or weight more than 150 kg

Related Conditions & MeSH terms

• Neuromuscular Blockade

Intervention

Drug:
• sugammadex

• Neostigmine

• Glycopyrrolate

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of South Florida	Merck Sharp & Dohme Corp.

References & Publications (17)

Abad-Gurumeta A, Ripollés-Melchor J, Casans-Francés R, Espinosa A, Martínez-Hurtado E, Fernández-Pérez C, Ramírez JM, López-Timoneda F, Calvo-Vecino JM; Evidence Anaesthesia Review Group. A systematic review of sugammadex vs neostigmine for reversal of neuromuscular blockade. Anaesthesia. 2015 Dec;70(12):1441-52. doi: 10.1111/anae.13277. Review. — View Citation

Butterly A, Bittner EA, George E, Sandberg WS, Eikermann M, Schmidt U. Postoperative residual curarization from intermediate-acting neuromuscular blocking agents delays recovery room discharge. Br J Anaesth. 2010 Sep;105(3):304-9. doi: 10.1093/bja/aeq157. Epub 2010 Jun 24. — View Citation

Cheng CR, Sessler DI, Apfel CC. Does neostigmine administration produce a clinically important increase in postoperative nausea and vomiting? Anesth Analg. 2005 Nov;101(5):1349-55. — View Citation

Chhibber AK, Lustik SJ, Thakur R, Francisco DR, Fickling KB. Effects of anticholinergics on postoperative vomiting, recovery, and hospital stay in children undergoing tonsillectomy with or without adenoidectomy. Anesthesiology. 1999 Mar;90(3):697-700. — View Citation

Della Rocca G, Pompei L, Pagan DE Paganis C, Tesoro S, Mendola C, Boninsegni P, Tempia A, Manstretta S, Zamidei L, Gratarola A, Murabito P, Fuggiano L, DI Marco P. Reversal of rocuronium induced neuromuscular block with sugammadex or neostigmine: a large observational study. Acta Anaesthesiol Scand. 2013 Oct;57(9):1138-45. doi: 10.1111/aas.12155. Epub 2013 Jul 14. — View Citation

Hemmerling TM, Zaouter C, Geldner G, Nauheimer D. Sugammadex--a short review and clinical recommendations for the cardiac anesthesiologist. Ann Card Anaesth. 2010 Sep-Dec;13(3):206-16. doi: 10.4103/0971-9784.69052. Review. — View Citation

Herbstreit F, Peters J, Eikermann M. Impaired upper airway integrity by residual neuromuscular blockade: increased airway collapsibility and blunted genioglossus muscle activity in response to negative pharyngeal pressure. Anesthesiology. 2009 Jun;110(6):1253-60. doi: 10.1097/ALN.0b013e31819faa71. — View Citation

Koyuncu O, Turhanoglu S, Ozbakis Akkurt C, Karcioglu M, Ozkan M, Ozer C, Sessler DI, Turan A. Comparison of sugammadex and conventional reversal on postoperative nausea and vomiting: a randomized, blinded trial. J Clin Anesth. 2015 Feb;27(1):51-6. doi: 10.1016/j.jclinane.2014.08.010. Epub 2014 Dec 24. — View Citation

Murphy GS, Szokol JW, Marymont JH, Greenberg SB, Avram MJ, Vender JS, Nisman M. Intraoperative acceleromyographic monitoring reduces the risk of residual neuromuscular blockade and adverse respiratory events in the postanesthesia care unit. Anesthesiology. 2008 Sep;109(3):389-98. doi: 10.1097/ALN.0b013e318182af3b. — View Citation

Murphy GS, Szokol JW, Marymont JH, Greenberg SB, Avram MJ, Vender JS. Residual neuromuscular blockade and critical respiratory events in the postanesthesia care unit. Anesth Analg. 2008 Jul;107(1):130-7. doi: 10.1213/ane.0b013e31816d1268. — View Citation

Naguib M, Brull SJ. Update on neuromuscular pharmacology. Curr Opin Anaesthesiol. 2009 Aug;22(4):483-90. doi: 10.1097/ACO.0b013e32832b8cff. Review. — View Citation

Plaud B, Meretoja O, Hofmockel R, Raft J, Stoddart PA, van Kuijk JH, Hermens Y, Mirakhur RK. Reversal of rocuronium-induced neuromuscular blockade with sugammadex in pediatric and adult surgical patients. Anesthesiology. 2009 Feb;110(2):284-94. doi: 10.1097/ALN.0b013e318194caaa. — View Citation

Proakis AG, Harris GB. Comparative penetration of glycopyrrolate and atropine across the blood--brain and placental barriers in anesthetized dogs. Anesthesiology. 1978 May;48(5):339-44. — View Citation

Pühringer FK, Rex C, Sielenkämper AW, Claudius C, Larsen PB, Prins ME, Eikermann M, Khuenl-Brady KS. Reversal of profound, high-dose rocuronium-induced neuromuscular blockade by sugammadex at two different time points: an international, multicenter, randomized, dose-finding, safety assessor-blinded, phase II trial. Anesthesiology. 2008 Aug;109(2):188-97. doi: 10.1097/ALN.0b013e31817f5bc7. — View Citation

Sasaki N, Meyer MJ, Malviya SA, Stanislaus AB, MacDonald T, Doran ME, Igumenshcheva A, Hoang AH, Eikermann M. Effects of neostigmine reversal of nondepolarizing neuromuscular blocking agents on postoperative respiratory outcomes: a prospective study. Anesthesiology. 2014 Nov;121(5):959-68. doi: 10.1097/ALN.0000000000000440. — View Citation

Tramèr MR, Fuchs-Buder T. Omitting antagonism of neuromuscular block: effect on postoperative nausea and vomiting and risk of residual paralysis. A systematic review. Br J Anaesth. 1999 Mar;82(3):379-86. — View Citation

Turner DA, Smith G. Evaluation of the combined effects of atropine and neostigmine on the lower oesophageal sphincter. Br J Anaesth. 1985 Oct;57(10):956-9. — View Citation

* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Operating Room (OR) Turnover Time When Using Sugammadex Instead of Combination of Neostigmine and Glycopyrrolate.		through start of next surgery, average of 2 hours
Secondary	Number of Patients Who Experience Postoperative Nausea and Vomiting, Post-operative Pain, and Post-operative Complications		through discharge from hospital, average of 72 hours