MicrolaryngoscopyPhase 4NCT03111121
Use of Sugammadex for Reversal of Paralysis in Microlaryngoscopy
A Phase 4 study testing Sugammadex, neostigmine and glycopyrrolate in people with Microlaryngoscopy and Rigid Bronchoscopy, run by West Virginia University at 1 site in United States.
Trial summary
Use of Muscle relaxant and reversal with Sugammadex at end of airway procedures will reduce the time to extubation after end of procedure Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Microlaryngoscopy, Rigid Bronchoscopy
- What is being tested?
- Sugammadex, neostigmine and glycopyrrolate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- 1 siteUnited States
- Study dates
- 4 May 2017to 30 May 2019
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 10Show fewer
- 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.
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
WVU Healthcare Ruby Memorial Hospital
Morgantown, West Virginia, 26506
About this study
Use of Muscle relaxant and reversal with Sugammadex at end of airway procedures will reduce the time to extubation after end of procedure
Read the detailed description
This is a prospective, clinical interventional, randomized single blinded single center study.
Hypotheses:
Primary Hypothesis: Use of Muscle relaxant and reversal with Sugammadex at end of airway procedures will reduce the time to extubation after end of procedure
Secondary Hypotheses:
Surgeon will report optimal surgical conditions for ease of exposure
Have less hemodynamic changes in the OR and PACU. ∆ in BP, HR and CO2 from base-line and incidence /frequency of 20% change in BP from baseline vitals (baseline= pre-induction vitals)
Decrease the amount of inhaled anesthetics
Decreased narcotics needed intra-operatively and post operatively
Decrease the total OR time
Subjects will meet ALDRETE PACU discharge criteria quicker in the PACU
Subject will have less adverse events and severe adverse events such as - hypotension, arrhythmia, hypoxia, stridor and re-intubation.
We note that the nurses in PACU will be blinded to whether the subjects were in Group 1 or 2.
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
Both groups will receive standard anti-nausea prophylaxis - Ondansetran and Decadran intraoperative.
After induction, the amount of inhaled anesthetic and remifentanil used will be titrated based on hemodynamic parameters (maintained within 20% from baseline) and a BIS monitor.
All subjects will have TOF testing done every 5 minutes throughout the procedure and tabulated in the Electronic Medical Record (EMR).
At the end of the procedure patient will be extubated when the subject meets the following criteria:
Tidal volume : > 5 cc /Kg Respiratory rate: >8 /min O2sat > 95% ON 100% inspired oxygen
With vitals at 20% of baseline. Extubation will begin when the surgeon states, "We are done". This usually coincides with the withdrawal of the scope. The start and end times for extubation will be recorded in the Electronic Medical Record.
The PACU nurses will evaluate ALDRETE discharge criteria and make a note in the electronic medical records for the subject discharge time from PACU. The nurses in PACU will be the only evaluators of the subject who will be blinded to the two groups
- Conditions
- Microlaryngoscopy, Rigid Bronchoscopy
- Being tested
- Sugammadex, neostigmine, glycopyrrolate
- Keywords
- deeply anesthetized, ideal surgical exposure, muscle relaxation, Adults
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SugammadexDrug
receive reversal with sugammadex 4mg/kg
neostigmineDrug
receive reversal with neostigmine 0.04 mg/kg
glycopyrrolateDrug
receive reversal with glycopyrrolate (0.01 mg/kg)
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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 Receives: Drug: Sugammadex |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2017
- Study start4 May 2017
- Primary completion22 Jun 2018
- Study completion30 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for MicrolaryngoscopyStudies of the same condition, open and under way.
- More trials run by West Virginia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- West Virginia University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pavithra Ranganathan, MD, Principal investigator, West Virginia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03111121
- Sponsor's protocol ID
- 1610312153
- Status last verified
- Jul 2025
- First submitted
- 23 Mar 2017
- Last updated
- 20 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: no plan to share IPD
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Sugammadex for Reversal of Paralysis in Microlaryngoscopy
- ClinicalTrials.gov ID
- NCT03111121
- Acronym / sponsor ID
- 1610312153
- Conditions
- Microlaryngoscopy, Rigid Bronchoscopy
- Keywords
- deeply anesthetized, ideal surgical exposure, muscle relaxation, Adults
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- West Virginia UniversityUniversity, hospital or other
- Study start
- 4 May 2017 (actual)
- Primary completion
- 22 Jun 2018 (actual)
- Study completion
- 30 May 2019 (actual)
- First posted
- 12 Apr 2017 (actual)
- Results
- Posted 20 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Use of Muscle relaxant and reversal with Sugammadex at end of airway procedures will reduce the time to extubation after end of procedure
Detailed description
This is a prospective, clinical interventional, randomized single blinded single center study.
Hypotheses:
Primary Hypothesis: Use of Muscle relaxant and reversal with Sugammadex at end of airway procedures will reduce the time to extubation after end of procedure
Secondary Hypotheses:
Surgeon will report optimal surgical conditions for ease of exposure
Have less hemodynamic changes in the OR and PACU. ∆ in BP, HR and CO2 from base-line and incidence /frequency of 20% change in BP from baseline vitals (baseline= pre-induction vitals)
Decrease the amount of inhaled anesthetics
Decreased narcotics needed intra-operatively and post operatively
Decrease the total OR time
Subjects will meet ALDRETE PACU discharge criteria quicker in the PACU
Subject will have less adverse events and severe adverse events such as - hypotension, arrhythmia, hypoxia, stridor and re-intubation.
We note that the nurses in PACU will be blinded to whether the subjects were in Group 1 or 2.
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
Both groups will receive standard anti-nausea prophylaxis - Ondansetran and Decadran intraoperative.
After induction, the amount of inhaled anesthetic and remifentanil used will be titrated based on hemodynamic parameters (maintained within 20% from baseline) and a BIS monitor.
All subjects will have TOF testing done every 5 minutes throughout the procedure and tabulated in the Electronic Medical Record (EMR).
At the end of the procedure patient will be extubated when the subject meets the following criteria:
Tidal volume : > 5 cc /Kg Respiratory rate: >8 /min O2sat > 95% ON 100% inspired oxygen
With vitals at 20% of baseline. Extubation will begin when the surgeon states, "We are done". This usually coincides with the withdrawal of the scope. The start and end times for extubation will be recorded in the Electronic Medical Record.
The PACU nurses will evaluate ALDRETE discharge criteria and make a note in the electronic medical records for the subject discharge time from PACU. The nurses in PACU will be the only evaluators of the subject who will be blinded to the two groups
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Drug: neostigmine, Drug: glycopyrrolateReversal 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) |
| Group 2 | Active comparator | Drug: SugammadexReversal 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sugammadexreceive reversal with sugammadex 4mg/kg | Drug | Group 2 |
| neostigminereceive reversal with neostigmine 0.04 mg/kg | Drug | Group 1 |
| glycopyrrolatereceive reversal with glycopyrrolate (0.01 mg/kg) | Drug | Group 1 |
Primary outcome
Time to Extubation After End of Procedure
Time frame: Intraoperative
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. no plan to share IPD
Related trials for Microlaryngoscopy
Recruiting
Force Sensor Study
Laryngeal Disease, Post-operative Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pavithra Ranganathan, MD principal investigator
West Virginia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sugammadex, neostigmine and glycopyrrolate in people with Microlaryngoscopy and Rigid Bronchoscopy, run by West Virginia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Extubation After End of Procedure (time frame: Intraoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2025.