Study to Determine if Administration of Sugammadex Impacts Hospital Efficiency

NCT02860507 | Completed Phase 4 Results

• 1 other identifier: TGH015
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Neuromuscular Blockade

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Number of Patients Who Experience Postoperative Nausea and Vomiting, Post-operative Pain, and Post-operative Complications

  through discharge from hospital, average of 72 hours

Study Arms (2)

Neostigmine + Glycopyrrolate

ACTIVE COMPARATOR

Neostigmine 0.06 mg/kg and Glycopyrrolate 0.04mg/kg iv

Drug: Neostigmine; Drug: Glycopyrrolate

sugammadex

EXPERIMENTAL

Sugammadex 4mg/kg

Drug: sugammadex

Interventions

sugammadex DRUG

Also known as: Bridion

sugammadex

Neostigmine DRUG

Neostigmine + Glycopyrrolate

Glycopyrrolate DRUG

Neostigmine + Glycopyrrolate

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients scheduled for open ventral hernia repair or open colectomy
• ASA class I-III
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of South Florida: lead
• Merck Sharp & Dohme LLC: collaborator

Related Publications (17)

• 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. doi: 10.1093/bja/57.10.956.

  PMID: 4041322 BACKGROUND

• 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. doi: 10.1097/00000542-197805000-00007. No abstract available.

  PMID: 646152 BACKGROUND

• 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. doi: 10.1097/00000542-199903000-00010.

  PMID: 10078669 BACKGROUND

• Tramer 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. doi: 10.1093/bja/82.3.379.

  PMID: 10434820 BACKGROUND

• 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):1349-1355. doi: 10.1213/01.ANE.0000180992.76743.C9.

  PMID: 16243993 BACKGROUND

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

  PMID: 19384229 BACKGROUND

• Puhringer FK, Rex C, Sielenkamper 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.

  PMID: 18648227 BACKGROUND

• 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.

  PMID: 19194156 BACKGROUND

• 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.

  PMID: 20826961 BACKGROUND

• Abad-Gurumeta A, Ripolles-Melchor J, Casans-Frances R, Espinosa A, Martinez-Hurtado E, Fernandez-Perez C, Ramirez JM, Lopez-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.

  PMID: 26558858 BACKGROUND

• 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.

  PMID: 25544263 BACKGROUND

• 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.

  PMID: 25225821 BACKGROUND

• 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.

  PMID: 18635478 BACKGROUND

• 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.

  PMID: 19417617 BACKGROUND

• 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.

  PMID: 18719436 BACKGROUND

• 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.

  PMID: 20576632 BACKGROUND

• 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.

  PMID: 23849107 BACKGROUND

MeSH Terms

Interventions

Sugammadex; Neostigmine; Glycopyrrolate

Intervention Hierarchy (Ancestors)

gamma-Cyclodextrins; Cyclodextrins; Macrocyclic Compounds; Polycyclic Compounds; Dextrins; Starch; Glucans; Polysaccharides; Carbohydrates; Phenylammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals; Onium Compounds; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Chadwick Neal / Medical Affairs Director
• Organization: Merck Pharmaceuticals

chadwick.neal@merck.com

2056010605

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants, Care Providers, Investigators, and Outcome Assessors are blinded from the type of NMBA reversal agent used prior to completion of data collection
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Anesthesiologist & Director of Research, SE

Model Details: Prospective Randomized Double Blinded

Study Record Dates

• First Submitted: August 2, 2016
• First Posted: August 9, 2016
• Study Start: August 1, 2016
• Primary Completion: February 1, 2018
• Study Completion: February 1, 2018
• Last Updated: April 12, 2019
• Results First Posted: April 12, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will share