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

NCT03168308 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: STU 032017-030
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

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 90 minutes postoperatively for any adverse events.

Conditions

Neuromuscular Blockade

Outcome Measures

Primary Outcomes (1)

• Number of Hypoxic Episodes

  Hypoxia was defined as an episode of peripheral oxygen saturation (SpO2) \<94% on ≤2 L/min of oxygen by nasal cannula, or a SpO2 \<98% on ≥2 L/min of oxygen, or postoperative SpO2 of ≥5% reduction compared to preoperative values.

  Through patient's stay in the early postoperative period, approximately 1-2 hours.

Secondary Outcomes (2)

• Time to Complete Reversal of Neuromuscular Blockade

  From time of reversal to complete reversal of neuromuscular blockade (train of four ratio ≥0.9), approximately 1 hour

• Number of Participants Who Needed Rescue Sugammadex After Initial Reversal of Neuromuscular Blockade

  From time of reversal to 80 minutes after arrival in the post-anesthesia care unit, approximately 1-2 hours.

Study Arms (2)

Neostigmine & Glycopyrrolate

ACTIVE COMPARATOR

Patients randomized to receive Neostigmine w/ Glycopyrrolate

Drug: Neostigmine w/ Glycopyrrolate

Sugammadex

ACTIVE COMPARATOR

Patients randomized to receive Sugammadex

Drug: Sugammadex

Interventions

Sugammadex DRUG

Sugammadex 2 mg/kg

Sugammadex

Neostigmine w/ Glycopyrrolate DRUG

Neostigmine 50 mcg/kg, maximum 5 mg Glycopyrrolate, 8 mcg/kg, maximum 1 mg

Neostigmine & Glycopyrrolate

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Parkland Health & Hospital System

Dallas, Texas, 75211, United States

Location

MeSH Terms

Interventions

Sugammadex; Glycopyrrolate

Intervention Hierarchy (Ancestors)

gamma-Cyclodextrins; Cyclodextrins; Macrocyclic Compounds; Polycyclic Compounds; Dextrins; Starch; Glucans; Polysaccharides; Carbohydrates; Quaternary Ammonium Compounds; Amines; Organic Chemicals; Onium Compounds; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Tiffany Moon, MD
• Organization: University of Texas Southwestern

Tiffany.Moon@UTSouthwestern.edu

4694195790

Study Officials

• Tiffany Moon, MD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Director of Resident Research

Study Record Dates

• First Submitted: May 23, 2017
• First Posted: May 30, 2017
• Study Start: September 26, 2017
• Primary Completion: September 30, 2019
• Study Completion: September 30, 2019
• Last Updated: June 4, 2020
• Results First Posted: February 19, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)