NCT03111121

Use of Sugammadex for Reversal of Paralysis in Microlaryngoscopy

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 79 (actual)
• Sponsor: West Virginia University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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

Conditions

• Microlaryngoscopy
• Rigid Bronchoscopy

Interventions

Type	Name	Description
DRUG	Sugammadex	receive reversal with sugammadex 4mg/kg
DRUG	neostigmine	receive reversal with neostigmine 0.04 mg/kg
DRUG	glycopyrrolate	receive reversal with glycopyrrolate (0.01 mg/kg)

Timeline

• Start date: 2017-05-04
• Primary completion: 2018-06-22
• Completion: 2019-05-30
• First posted: 2017-04-12
• Last updated: 2025-07-20
• Results posted: 2025-07-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study