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The Effect of Sugammadex Versus Neostigmine During Neuromuscular Blockade Reversal

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03579589
Recruitment Status : Active, not recruiting
First Posted : July 6, 2018
Last Update Posted : August 29, 2019
Sponsor:
Information provided by (Responsible Party):
Sergio Bergese, Ohio State University

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.

Condition or disease Intervention/treatment Phase
Neuromuscular Blockade Drug: Sugammadex vs Neostigmine Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Sugammadex vs Neostigmine
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of Sugammadex Versus Neostigmine During Neuromuscular Blockade Reversal in Outpatient Surgeries - An Evaluation of Clinical and Associated Health Care Cost
Actual Study Start Date : August 15, 2018
Estimated Primary Completion Date : December 15, 2019
Estimated Study Completion Date : December 15, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Sugammadex
  • 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
Patients will be randomized into either Sugammadex or Neostigmine neuromuscular blockade reversal.

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




Primary Outcome Measures :
  1. Sugammadex blockade reversal reduce discharge to PACU. [ Time Frame: 1 hour ]
    Time from peritoneal closure (port sites) to anesthesia readiness for OR discharge to PACU


Secondary Outcome Measures :
  1. Extubation time [ Time Frame: 1 hour ]
    Time from IP administration to extubation

  2. TOF less than 0.9 [ Time Frame: 1 hour ]
    Time from IP administration to TOF ≥ 0.9

  3. PACU [ Time Frame: 1 hour ]
    Time from IP administration to anesthesia readiness for OR discharge to PACU



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Participating in another interventional study drug within 30 days prior to their recruitment
  2. Special population (Pregnant, Inmate, Breastfeeding)
  3. History of allergy to sugammadex or rocuronium
  4. Any medication known to interfere with NMBA or sugammadex
  5. 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03579589


Locations
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United States, Ohio
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Ohio State University
Investigators
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Principal Investigator: Sergio D Bergese, MD The Ohio State University Wexner Medical Center
Publications:
Co, M. Bridion® (sugammadex) injection, for intravenous use: US prescribing information. 2015. 2015 [cited 2016 10 OCT ]; http://www.accessdata.fda.gov/. ].
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).

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Responsible Party: Sergio Bergese, Professor Clinical, Ohio State University
ClinicalTrials.gov Identifier: NCT03579589    
Other Study ID Numbers: 2018H0102
First Posted: July 6, 2018    Key Record Dates
Last Update Posted: August 29, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Sergio Bergese, Ohio State University:
Neuromuscular Blockade Reversal
Outpatient Surgery
Additional relevant MeSH terms:
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Neostigmine
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Parasympathomimetics
Autonomic Agents
Peripheral Nervous System Agents