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Comparison of Sugammadex and Neostigmine During PACU Stay

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04096144
Recruitment Status : Not yet recruiting
First Posted : September 19, 2019
Last Update Posted : September 19, 2019
Sponsor:
Information provided by (Responsible Party):
Enrico Camporesi, University of South Florida

Brief Summary:

Sugammadex was approved for post-operative use in the operating room (OR) and post-anesthesia recovery unit (PACU) of our quaternary facility, Tampa General Hospital. The approval came with administrative limitations: 2mg/kg dose only and for the first year its utilization was limited as replacement for up to half of Neostigmine/Glycopyrrolate use.

An MUE evaluation was completed for a retrospective chart review from March 2017 to December 2017 (10 months) to assess all cases in which patients received Sugammadex or Neostigmine. During the year of data collection, we also noted a widespread tendency to reduce the usage of narcotics.

A t-test comparison of the length of stay (LOS) in the PACU revealed a highly significant difference between the LOS in PACU for both drugs. On average, patients receiving Sugammadex were discharged from the PACU 43 minutes earlier than patients who received Neostigmine/Glycopyrrolate. The patient mix in both groups was similar, but these data were obtained retrospectively by a pharmacy chart review.


Condition or disease Intervention/treatment Phase
Neuromuscular Blockade Drug: Neuromuscular Blocking Agents Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Evaluation of Sugammadex Vs. Neostigmine in the PACU for Abdominal Surgeries
Estimated Study Start Date : October 15, 2019
Estimated Primary Completion Date : March 1, 2020
Estimated Study Completion Date : June 15, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Neostigmine
This is the standard Neuromuscular reversal drug that has been in standard care for the past thirty years. Dose: -Neostigmine: 0.03-0.07 mg/kg by intravenous route.
Drug: Neuromuscular Blocking Agents
Neuromuscular agents will be used to block muscle function for the safety and efficiency of the procedure. At the procedure's conclusion, neuromusclar agents such as Neostigmine or Sugammadex will be used to reverse the neuromuscular reversal.

Experimental: Sugammadex

Used for Neuromuscular reversal; Sugammadex is devoid of the parasympathetic effects caused by Neostigmine.

Dose: -Sugammadex: 2-4 mg/kg (4 mg/kg if no twitch responses after initial stimulation), intravenous route.

Drug: Neuromuscular Blocking Agents
Neuromuscular agents will be used to block muscle function for the safety and efficiency of the procedure. At the procedure's conclusion, neuromusclar agents such as Neostigmine or Sugammadex will be used to reverse the neuromuscular reversal.




Primary Outcome Measures :
  1. Length of Post Anesthesia Care Unit (PACU) stay [ Time Frame: 6 months ]
    Time spent in the recovery room (PACU).

  2. Pain (Visual Analog Scale) VAS scores [ Time Frame: 6 months ]
    Evaluation of the level of pain

  3. Aldrete Score [ Time Frame: 6 months ]
    Evaluation of level of alertness of the patient at the conclusion of PACU stay for discharge.

  4. Pulse Oximetry [ Time Frame: 6 months ]
    Finger Saturation

  5. Blood Pressure upon PACU discharge [ Time Frame: 6 months ]
    Evaluation of Blood Pressure at the conclusion of PACU stay.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 18-75 years of age
  • Patients with surgeries with duration of 90-120 minutes
  • ASA Patients I-III (Appendix A)
  • Patients admitted to TGH for abdominal hernia repair, cholecystectomy and/or abdominal surgery as performed by Dr. Albrink
  • BMI > 30

Exclusion Criteria:

  • <18 years of age
  • ASA Patients IV and above (Appendix A)
  • Patients with allergic reactions to Neostigmine+Glycopyrrolate and/or Sugammadex

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): NCT04096144


Contacts
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Contact: Enrico M Camporesi, MD 8136009094 ecampore@health.usf.edu
Contact: Maha Balouch, MA 8137315810 maha_balouch@teamhealth.com

Locations
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United States, Florida
Tampa General Hospital
Tampa, Florida, United States, 33606
Contact: Enrico M Camporesi, MD    813-600-9094    ecampore@health.usf.edu   
Sponsors and Collaborators
University of South Florida
Investigators
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Principal Investigator: Enrico M Camporesi, MD TEAMHealth Anesthesia/Tampa General Hospital
Study Chair: Maha Balouch, MA TEAMHealth Anesthesia/Tampa General Hospital
Principal Investigator: Michael Albrink, MD Tampa General Hospital
Publications:
Enten G, Albrink M, Deng J, Melloni G, Camporesi EM, & Mangar D. Sugammadex Administration Shortens Reversal Times but not OR Turnover Times. Case Studies in Surgery. 2019 Jul;5(1): 27.
Presented at 2019 American Society of Anesthesiologists meeting: Mangar D, Pease S, Guzman S, Abowali H, Balouch M, & Camporesi EM. PACU Length of Stay after Neuromuscular Blocker Reversal with Sugammadex. Orlando, FL.

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Responsible Party: Enrico Camporesi, Professor of Surgery, University of South Florida
ClinicalTrials.gov Identifier: NCT04096144    
Other Study ID Numbers: 41493
First Posted: September 19, 2019    Key Record Dates
Last Update Posted: September 19, 2019
Last Verified: September 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.: Yes
Keywords provided by Enrico Camporesi, University of South Florida:
Post anesthesia care unit
sugammadex
neostigmine
neuromuscular reversal
Additional relevant MeSH terms:
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Neuromuscular Blocking Agents
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs