Rigid Bronchoscopy Clinical Trial
Official title:
Use of Sugammadex for Reversal of Paralysis in Microlaryngoscopy
Use of Muscle relaxant and reversal with Sugammadex at end of airway procedures will reduce the time to extubation after end of procedure
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
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Not yet recruiting |
NCT04099069 -
The Impacts of the Different Anesthesia Methods on Patients of Transbronchial Cryobiopsy
|
N/A |