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Sugammadex vs. Neostigmine for Neuromuscular Blockade Reversal in Thoracic Surgical Patients

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ClinicalTrials.gov Identifier: NCT03168308
Recruitment Status : Completed
First Posted : May 30, 2017
Last Update Posted : October 22, 2019
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Tiffany B Moon, University of Texas Southwestern Medical Center

Brief Summary:
This prospective, randomized, double blinded study is intended to enroll a total of 92 patients undergoing thoracic surgery with general endotracheal anesthesia at Parkland Hospital. Patients will be randomized to receive either neostigmine or sugammadex for reversal of neuromuscular blockade. Merck, Inc. will supply the sugammadex through an agreement with Parkland Investigational Drug Services. Neostigmine is readily available for anesthesiologists to use and is the current standard of care for reversal of neuromuscular blockade. A standardized anesthetic protocol that is usual and customary for the type of operation the patient is having will be provided to the anesthesia teams of enrolled subjects. The remainder of the anesthetic care of the subject will not deviate from the standard of care. The surgeon, anesthesia team, postoperative recovery nurse, and research assistant will be blinded as to which reversal drug the patient receives. The only individual that will know to which drug the patient has been randomized will be the pharmacist who draws up the medication(s). A blinded research assistant will record postoperative outcomes and the patient will be followed until postoperative day (POD) 3 for any adverse events.

Condition or disease Intervention/treatment Phase
Neuromuscular Blockade Drug: Sugammadex Drug: Neostigmine w/ Glycopyrrolate Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 92 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Sugammadex Versus Neostigmine for Reversal of Rocuronium-induced Neuromuscular Blockade: A Study of Thoracic Surgical Patients
Actual Study Start Date : September 26, 2017
Actual Primary Completion Date : September 30, 2019
Actual Study Completion Date : September 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Neostigmine & Glycopyrrolate
Patients randomized to receive Neostigmine w/ Glycopyrrolate
Drug: Neostigmine w/ Glycopyrrolate
Neostigmine 50 mcg/kg, maximum 5 mg Glycopyrrolate, 8 mcg/kg, maximum 1 mg

Active Comparator: Sugammadex
Patients randomized to receive Sugammadex
Drug: Sugammadex
Sugammadex 2 mg/kg




Primary Outcome Measures :
  1. Incidence of Hypoxia [ Time Frame: Through patient's stay in the early postoperative period, approximately 1-2 hours. ]
    To determine whether reversal of rocuronium-induced neuromuscular blockade with sugammadex versus neostigmine in thoracic surgical patients results in a decreased incidence of hypoxia in the early postoperative period.


Secondary Outcome Measures :
  1. Postoperative Recovery measured by the postoperative quality recovery scale (PQRS) [ Time Frame: At 15, 40, and 80 minutes after arrival in the early postoperative period ]
    To determine if reversal with sugammadex versus neostigmine results in improved postoperative recovery, as measured by the postoperative quality recovery scale (PQRS).



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18-80 years old
  • Undergoing non-emergent thoracic surgery
  • ASA physical status classification 1 to 4
  • Willing and able to consent in English or Spanish
  • No personal history of neuromuscular disease

Exclusion Criteria:

  • Age less than 18 or older than 80
  • Patient does not speak English or Spanish
  • Planned postoperative intubation or ICU admission
  • Allergy to sugammadex, neostigmine, glycopyrrolate, or rocuronium
  • Family or personal history of malignant hyperthermia
  • Patient refusal
  • Monitored anesthesia care (MAC) or regional anesthesia planned
  • Pregnant or nursing women
  • "Stat" (emergent) cases
  • Estimated creatinine clearance <30 mL/min
  • Pre-existing muscle weakness of any etiology
  • Patients on toremifene (a selective estrogen receptor modulator)
  • Women on oral contraceptives who do not wish to use a non-hormonal method of contraception for 7 days following surgery

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): NCT03168308


Locations
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United States, Texas
Parkland Health & Hospital System
Dallas, Texas, United States, 75211
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Merck Sharp & Dohme Corp.
Investigators
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Principal Investigator: Tiffany Moon, MD UT Southwestern Medical Center

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Responsible Party: Tiffany B Moon, Assistant Professor, Director of Resident Research, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT03168308     History of Changes
Other Study ID Numbers: STU 032017-030
First Posted: May 30, 2017    Key Record Dates
Last Update Posted: October 22, 2019
Last Verified: October 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
Additional relevant MeSH terms:
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Glycopyrrolate
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
Adjuvants, Anesthesia
Muscarinic Antagonists
Cholinergic Antagonists