Use of Sugammadex for Reversal of Paralysis in Microlaryngoscopy

Study Overview
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Brief Summary
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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
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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

Official Title
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Use of Sugammadex for Reversal of Paralysis in Microlaryngoscopy

Conditions
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Microlaryngoscopy, Rigid Bronchoscopy

Intervention / Treatment
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* Drug: Sugammadex
* Drug: neostigmine
* Drug: glycopyrrolate


Participation Criteria
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Eligibility Criteria
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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. -

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1<br>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<br>* receive reversal with neostigmine 0.04 mg/kg<br>Drug: glycopyrrolate<br>* receive reversal with glycopyrrolate (0.01 mg/kg)<br>|
| Active Comparator: Group 2<br>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<br>* receive reversal with sugammadex 4mg/kg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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deeply anesthetized, ideal surgical exposure, muscle relaxation, Adults