The Effect of Sugammadex Versus Neostigmine During Neuromuscular Blockade Reversal

NCT03579589 | Completed Phase 1 FDA Drug

• 1 other identifier: 2018H0102
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Patients who undergo surgery receive drugs called neuromuscular blocking agents (NMBA) that to block the activity of muscles. When the surgery is over, the block needs to be reversed. Suggammadex and neostigmine are examples of drugs that reverse blocks. This study aims to investigate if sugammadex is associated with a significantly reduced time to discharge from the operating room to the postoperative unit when compared to neostigmine.

Conditions

Neuromuscular Blockade

Keywords

Neuromuscular Blockade Reversal; Outpatient Surgery

Outcome Measures

Primary Outcomes (1)

• Sugammadex blockade reversal reduce discharge to PACU.

  Time from peritoneal closure (port sites) to anesthesia readiness for OR discharge to PACU

  1 hour

Secondary Outcomes (3)

• Extubation time

  1 hour

• TOF less than 0.9

  1 hour

• PACU

  1 hour

Study Arms (2)

Sugammadex

ACTIVE COMPARATOR

* If spontaneous recovery has reached second twitch after TOF: 2 mg/kg * If spontaneous recovery has reached between 1-2 post-tetanic counts but no twitch responses to TOF: 4 mg/kg * When there is a clinical need to reverse NMB within 3 min of a single dose of rocuronium (1.2 mg/kg): 16 mg/kg

Drug: Sugammadex vs Neostigmine

Neostigmine

ACTIVE COMPARATOR

50 µg. Kg-1 will be administered after spontaneous recovery has reached fourth twitch after TOF in accordance with our institutional standard procedures and published literature.

Drug: Sugammadex vs Neostigmine

Interventions

Sugammadex vs Neostigmine DRUG

Patients will be randomized into either Sugammadex or Neostigmine neuromuscular blockade reversal.

Neostigmine; Sugammadex

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects undergoing outpatient surgeries (laparoscopic cholecystectomy, laparoscopic hernia repair, laparoscopic appendectomy) under general anesthesia requiring rocuronium-induced neuromuscular blockade
• Male or female patient 18 years and older
• Able to consent
• American Society of Anesthesiologist (ASA) physical status of I, II, or III

You may not qualify if:

• Participating in another interventional study drug within 30 days prior to their recruitment
• Special population (Pregnant, Inmate, Breastfeeding)
• History of allergy to sugammadex or rocuronium
• Any medication known to interfere with NMBA or sugammadex
• Presence of any clinical condition as determined by the investigator that exclude the patient from the trial such as COPD, CKD, and neuromuscular or neurodegenerative diseases

Sponsors & Collaborators

• Ohio State University: lead

Study Sites (1)

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

Location

Related Publications (12)

• Sokol-Kobielska E. Sugammadex - indications and clinical use. Anaesthesiol Intensive Ther. 2013 Apr-Jun;45(2):106-10. doi: 10.5603/AIT.2013.0023.

  PMID: 23877905 BACKGROUND

• Ali HH, Utting JE, Gray C. Stimulus frequency in the detection of neuromuscular block in humans. Br J Anaesth. 1970 Nov;42(11):967-78. doi: 10.1093/bja/42.11.967. No abstract available.

  PMID: 5488360 BACKGROUND

• Sundman E, Witt H, Olsson R, Ekberg O, Kuylenstierna R, Eriksson LI. The incidence and mechanisms of pharyngeal and upper esophageal dysfunction in partially paralyzed humans: pharyngeal videoradiography and simultaneous manometry after atracurium. Anesthesiology. 2000 Apr;92(4):977-84. doi: 10.1097/00000542-200004000-00014.

  PMID: 10754616 BACKGROUND

• Keating GM. Sugammadex: A Review of Neuromuscular Blockade Reversal. Drugs. 2016 Jul;76(10):1041-52. doi: 10.1007/s40265-016-0604-1.

  PMID: 27324403 BACKGROUND

• Nag K, Singh DR, Shetti AN, Kumar H, Sivashanmugam T, Parthasarathy S. Sugammadex: A revolutionary drug in neuromuscular pharmacology. Anesth Essays Res. 2013 Sep-Dec;7(3):302-6. doi: 10.4103/0259-1162.123211.

  PMID: 25885973 BACKGROUND

• Co, M. Bridion® (sugammadex) injection, for intravenous use: US prescribing information. 2015. 2015 [cited 2016 10 OCT ]; http://www.accessdata.fda.gov/. ].

  BACKGROUND

• Grintescu, I., et al., Comparison of the cost-effectiveness of sugammadex and neostigmine during general anaesthesia for laparoscopic cholecystectomy. BJA: The British Journal of Anaesthesia, 2009. 103(6).

  BACKGROUND

• Carron M, Zarantonello F, Tellaroli P, Ori C. Efficacy and safety of sugammadex compared to neostigmine for reversal of neuromuscular blockade: a meta-analysis of randomized controlled trials. J Clin Anesth. 2016 Dec;35:1-12. doi: 10.1016/j.jclinane.2016.06.018. Epub 2016 Aug 4.

  PMID: 27871504 BACKGROUND

• Paton F, Paulden M, Chambers D, Heirs M, Duffy S, Hunter JM, Sculpher M, Woolacott N. Sugammadex compared with neostigmine/glycopyrrolate for routine reversal of neuromuscular block: a systematic review and economic evaluation. Br J Anaesth. 2010 Nov;105(5):558-67. doi: 10.1093/bja/aeq269. Epub 2010 Oct 8.

  PMID: 20935005 BACKGROUND

• Donati F. Residual paralysis: a real problem or did we invent a new disease? Can J Anaesth. 2013 Jul;60(7):714-29. doi: 10.1007/s12630-013-9932-8. Epub 2013 Apr 27.

  PMID: 23625545 BACKGROUND

• Hunter JM. Reversal of residual neuromuscular block: complications associated with perioperative management of muscle relaxation. Br J Anaesth. 2017 Dec 1;119(suppl_1):i53-i62. doi: 10.1093/bja/aex318.

  PMID: 29161387 BACKGROUND

• Fiorda Diaz J, Echeverria-Villalobos M, Esparza Gutierrez A, Dada O, Stoicea N, Ackermann W, Abdel-Rasoul M, Heard J, Uribe A, Bergese SD. Sugammadex versus neostigmine for neuromuscular blockade reversal in outpatient surgeries: A randomized controlled trial to evaluate efficacy and associated healthcare cost in an academic center. Front Med (Lausanne). 2022 Dec 8;9:1072711. doi: 10.3389/fmed.2022.1072711. eCollection 2022.

  PMID: 36569123 DERIVED

Study Officials

• Sergio D Bergese, MD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., Principal INvestigator, Clinical Assitant Professor

Model Details: Sugammadex vs Neostigmine

Study Record Dates

• First Submitted: April 3, 2018
• First Posted: July 6, 2018
• Study Start: August 15, 2018
• Primary Completion: December 15, 2019
• Study Completion: December 15, 2019
• Last Updated: August 11, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)