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Use of Sugammadex for Reversal of Paralysis in Microlaryngoscopy

Use of Sugammadex for Reversal of Paralysis in Microlaryngoscopy

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03111121
Enrollment
79
Registered
2017-04-12
Start date
2017-05-04
Completion date
2019-05-30
Last updated
2025-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Microlaryngoscopy, Rigid Bronchoscopy

Keywords

deeply anesthetized, ideal surgical exposure, muscle relaxation, Adults

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

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

Interventions

DRUGSugammadex

receive reversal with sugammadex 4mg/kg

DRUGneostigmine

receive reversal with neostigmine 0.04 mg/kg

DRUGglycopyrrolate

receive reversal with glycopyrrolate (0.01 mg/kg)

Sponsors

West Virginia University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Caregiver)

Masking description

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.

Intervention 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

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

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.

Exclusion criteria

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. \-

Design outcomes

Primary

MeasureTime frameDescription
Time to Extubation After End of ProcedureIntraoperativeWest 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.

Countries

United States

Participant flow

Participants by arm

ArmCount
Neostigmine
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) neostigmine: receive reversal with neostigmine 0.04 mg/kg glycopyrrolate: receive reversal with glycopyrrolate (0.01 mg/kg)
40
Sugammadex
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 Sugammadex: receive reversal with sugammadex 4mg/kg
39
Total79

Baseline characteristics

CharacteristicNeostigmineSugammadexTotal
Age, Continuous59.62 years
STANDARD_DEVIATION 10.99
60.04 years
STANDARD_DEVIATION 11.41
59.83 years
STANDARD_DEVIATION 0.296
Race and Ethnicity Not Collected0 Participants
Sex: Female, Male
Female
14 Participants16 Participants30 Participants
Sex: Female, Male
Male
26 Participants23 Participants49 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 400 / 39
other
Total, other adverse events
0 / 400 / 39
serious
Total, serious adverse events
0 / 400 / 39

Outcome results

Primary

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.

Time frame: Intraoperative

ArmMeasureValue (MEAN)Dispersion
NeostigmineTime to Extubation After End of Procedure11.06 MinutesStandard Deviation 6.51
SugammadexTime to Extubation After End of Procedure10.36 MinutesStandard Deviation 5.37

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026