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Phase 4 N=92 Randomized Double-blind Treatment

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

Neuromuscular Blockade

Enrolled (actual)
92
Serious AEs
5.4%
Results posted
Feb 2020
Primary outcome: Primary: Number of Hypoxic Episodes — 1; 0 episode(s)

Study Design & Population

Study type
Interventional
Phase
Phase 4
Interventions
Sugammadex (Drug); Neostigmine w/ Glycopyrrolate (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
University of Texas Southwestern Medical Center
Primary completion
Sep 2019

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Hypoxic Episodes
1; 0
SECONDARY
Time to Complete Reversal of Neuromuscular Blockade
40; 10
SECONDARY
Number of Participants Who Needed Rescue Sugammadex After Initial Reversal of Neuromuscular Blockade
5; 0

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 90 minutes postoperatively for any adverse events.

Eligibility Criteria

Inclusion Criteria

  • 18-80 years old
  • Undergoing non-emergent thoracic surgery
  • ASA physical status classification 2 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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03168308). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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