MedTrace Logo

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

NCT03168308 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 92

Last updated 2020-06-04

Study results available
· View outcomes & findings →

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

Interventions

DRUG

Sugammadex

Sugammadex 2 mg/kg

DRUG

Neostigmine w/ Glycopyrrolate

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

Sponsors & Collaborators

Principal Investigators

  • Tiffany Moon, MD · UT Southwestern Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-26
Primary Completion
2019-09-30
Completion
2019-09-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03168308 on ClinicalTrials.gov