Trial Outcomes & Findings for Use of Sugammadex for Reversal of Paralysis in Microlaryngoscopy (NCT NCT03111121)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

79 participants

Primary outcome timeframe

Intraoperative

Results posted on

2025-07-20

Participant Flow

Participant milestones

Participant milestones
Measure	Group 1 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)	Group 2 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
Overall Study STARTED	40	39
Overall Study COMPLETED	40	39
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Neostigmine n=40 Participants 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)	Sugammadex n=39 Participants 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	Total n=79 Participants Total of all reporting groups
Age, Continuous	59.62 years STANDARD_DEVIATION 10.99 • n=40 Participants	60.04 years STANDARD_DEVIATION 11.41 • n=39 Participants	59.83 years STANDARD_DEVIATION .296 • n=79 Participants
Sex: Female, Male Female	14 Participants n=40 Participants	16 Participants n=39 Participants	30 Participants n=79 Participants
Sex: Female, Male Male	26 Participants n=40 Participants	23 Participants n=39 Participants	49 Participants n=79 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Neostigmine n=40 Participants 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)	Sugammadex n=39 Participants 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
Time to Extubation After End of Procedure	11.06 Minutes Standard Deviation 6.51	10.36 Minutes Standard Deviation 5.37

Adverse Events

Neostigmine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Sugammadex

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Pavithra Ranganathan Ellison, MD

West Virginia University

Phone: 3045984122

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place