Comparison of Time to Extubation Using Sugammadex or Neostigmine

NCT04606901 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 26881
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

A prospective blinded randomized clinical trial to compare time to extubation using Sugammadex versus Neostigmine/glycopyrrolate as reversal agents after use of neuromuscular blockade agents in an outpatient bronchoscopy suite.

Conditions

Neuromuscular Blockade; Chronic Obstructive Pulmonary Disease

Keywords

Nondepolarizing neuromuscular blockade; sugammadex; bronchoscopy; outpatient; lung disease

Outcome Measures

Primary Outcomes (1)

• Number of Minutes to Return of Baseline Muscle Tone

  number of minutes from reversal dose to Train of Four (TOF) \>0.9 indicating full reversal of neuromuscular blockade agent

  1-20 minutes

Secondary Outcomes (1)

• Number of Minutes to Extubation

  1-30 minutes

Study Arms (2)

Sugammadex

ACTIVE COMPARATOR

Patients in this arm of the study will receive Sugammadex as the drug used to reverse neuromuscular blockade.

Drug: sugammadex

Neostigmine/Glycopyrrolate

ACTIVE COMPARATOR

Patients in this arm of the study will receive Neostigmine/Glycopyrrolate as the drugs used to reverse neuromuscular blockade

Drug: neostigmine/glycopyrrolate

Interventions

neostigmine/glycopyrrolate DRUG

neuromuscular blockade reversal agents

Also known as: prostigmin/robinul

Neostigmine/Glycopyrrolate

sugammadex DRUG

neuromuscular blockade reversal agent

Also known as: Bridion

Sugammadex

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• has diagnosis of COPD or ILD
• ASA 3 or 4
• procedure requires general anesthesia in the outpatient bronchoscopy suite
• glomerular filtration rate \> 30 ml/min

You may not qualify if:

• pregnant women
• prisoners
• those unable to consent for themselves
• procedures not requiring general anesthesia
• ASA 1 or 2

Sponsors & Collaborators

• Temple University: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Temple University Hospital

Philadelphia, Pennsylvania, 19140, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Lung Diseases

Interventions

Neostigmine; Glycopyrrolate; Sugammadex

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Ellen Hauck
• Organization: Temple University Hospital

ellen.hauck@tuhs.temple.edu

2674438719

Study Officials

• Ellen Hauck, DO PhD

  Lewis Katz School of Medicine at Temple University

  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, INVESTIGATOR
• Masking Details: Medications will be provided by Merck, Sharp \& Dohme Corp and will be delivered to the inpatient pharmacy in such a way as to blind the pharmacist. Patients will also not know which medication they are receiving
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Study groups will be treated equally except for delivery of the neuromuscular blockade reversal medication

Study Record Dates

• First Submitted: October 13, 2020
• First Posted: October 28, 2020
• Study Start: April 8, 2021
• Primary Completion: July 30, 2023
• Study Completion: July 30, 2023
• Last Updated: March 13, 2024
• Results First Posted: March 13, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)