Use of Sugammadex for Reversal of Paralysis in Microlaryngoscopy

NCT03111121 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: 1610312153
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 1

Brief Summary

Use of Muscle relaxant and reversal with Sugammadex at end of airway procedures will reduce the time to extubation after end of procedure

Conditions

Microlaryngoscopy; Rigid Bronchoscopy

Keywords

deeply anesthetized; ideal surgical exposure; muscle relaxation; Adults

Outcome Measures

Primary Outcomes (1)

• Time to Extubation After End of Procedure

  West Virginia University Hospitals use an electronic medical record (EMR) to chart the end of the procedure. When the surgeon states "We are done", always at withdrawal of the scope, extubation begins. From the time we chart end of procedure to the time of extubation is the extubation time. The start and end times for extubation will be recorded in the EMR.

  Intraoperative

Study Arms (2)

Group 1

ACTIVE COMPARATOR

Reversal of Paralysis in Microlaryngoscopy procedures: Inhaled anesthetics: sevoflurane at 1 MAC, remifentanil and intubation with rocuronium at 0.6-1.2 mg/kg (vitals maintained within 20% of baseline). Standard anti-nausea prophylaxis - Ondansetran and Decadran intraoperative.After induction; amount of inhaled anesthetic and remifentanil used will be titrated based on hemodynamic parameters (maintained within 20% from baseline) and a BIS monitor.TOF testing done every 5 minutes:Group 1 will receive reversal with neostigmine (0.04 mg/kg and glycopyrrolate (0.01 mg/kg)

Drug: neostigmine; Drug: glycopyrrolate

Group 2

ACTIVE COMPARATOR

Reversal of Paralysis in Microlaryngoscopy procedures: Inhaled anesthetics: sevoflurane at 1 MAC, remifentanil and intubation with rocuronium at 0.6-1.2 mg/kg (vitals maintained within 20% of baseline). Standard anti-nausea prophylaxis - Ondansetran and Decadran intraoperative.After induction; amount of inhaled anesthetic and remifentanil used will be titrated based on hemodynamic parameters (maintained within 20% from baseline) and a BIS monitor.TOF testing done every 5 minutes: Group2 will receive reversal with sugammadex 4mg/kg

Drug: Sugammadex

Interventions

Sugammadex DRUG

receive reversal with sugammadex 4mg/kg

Group 2

neostigmine DRUG

receive reversal with neostigmine 0.04 mg/kg

Group 1

glycopyrrolate DRUG

receive reversal with glycopyrrolate (0.01 mg/kg)

Group 1

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Microlaryngoscopy or rigid bronchoscopy for vocal cord and tracheal procedures
• Age 18 years or older,
• ASA physical status I-III
• Ability to give written informed consent.

You may not qualify if:

• Known or suspected neuromuscular disease/pre-existing weakness,
• Creatinine clearance less than 30 ml/min
• Bradycardia of less than 40 beats/min,
• Pregnancy, breast feeding women
• Known or suspected allergy to BRIDION® (sugammadex), neostigmine or rocuronium.
• Patients with contraindications towards sugammadex, neostigmine or rocuronium
• Patients included in another trial within the last 30 days
• Patients with legal guardians or surrogate decision making
• Patients who refuse to use non-hormonal contraceptive method or back-up method of contraception (such as condoms and spermicides) for the next 7 days if receiving sugammadex.

Sponsors & Collaborators

• West Virginia University: lead

Study Sites (1)

WVU Healthcare Ruby Memorial Hospital

Morgantown, West Virginia, 26506, United States

Location

MeSH Terms

Interventions

Sugammadex; Neostigmine; Glycopyrrolate

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Pavithra Ranganathan Ellison, MD
• Organization: West Virginia University

pavithra.ellison@hsc.wvu.edu

3045984122

Study Officials

• Pavithra Ranganathan, MD

  West Virginia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: SINGLE BLIND: The nurses in PACU will be the only evaluators of the subject who will be blinded to the two groups. The PACU nurses will evaluate ALDRETE discharge criteria and make a note in the electronic medical records for the subject discharge time from PACU.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Group 1: Inhaled anesthetics: sevoflurane at 1 MAC, remifentanil and intubation with rocuronium at 0.6-1.2 mg/kg (vitals maintained within 20% of baseline). Group 1 will receive reversal with neostigmine (0.04 mg/kg and glycopyrrolate (0.01 mg/kg) Group 2: Inhaled anesthetics: sevoflurane at 1 MAC, remifentanil and intubation with rocuronium at 0.6 -1.2 mg/kg (vitals maintained within 20% of baseline). Group 2 will receive reversal with sugammadex 4mg/kg

Study Record Dates

• First Submitted: March 23, 2017
• First Posted: April 12, 2017
• Study Start: May 4, 2017
• Primary Completion: June 22, 2018
• Study Completion: May 30, 2019
• Last Updated: July 20, 2025
• Results First Posted: July 20, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)