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

Study Overview

• Status: Recruiting
• Conditions: Microlaryngoscopy; Rigid Bronchoscopy
• Intervention / Treatment: Drug: neostigmine; Drug: glycopyrrolate; Drug: Sugammadex

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

• Study Type: Interventional
• Enrollment (Anticipated): 84
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Pavithra Ranganathan, MD; Phone Number: 304-598-4929; Email: ranganathanp@wvumedicine.org
• Study Contact Backup: Name: Connie Tennant, RN, CCRP; Phone Number: 304-598-4737; Email: cstennant@hsc.wvu.edu

Study Locations

• United States
  • West Virginia
    • Morgantown, West Virginia, United States, 26506
      • Recruiting
      • WVU Healthcare Ruby Memorial Hospital
      • Contact: Pavithra Ranganathan, MD; Phone Number: 304-598-4929; Email: ranganathanp@wvuhealthcare.com
      • Contact: Matthew Ellison, MD; Phone Number: 304-598-4929; Email: EllisonMa@wvuhealthcare.com
      • Principal Investigator: Pavithra Ranganathan, MD
      • Sub-Investigator: Matthew Ellison, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group 1; 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; receive reversal with neostigmine 0.04 mg/kg; Drug: glycopyrrolate; receive reversal with glycopyrrolate (0.01 mg/kg)
Active Comparator: Group 2; 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; receive reversal with sugammadex 4mg/kg

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: West Virginia University

Study record dates

Study Major Dates

• Study Start (Actual): May 4, 2017
• Primary Completion (Anticipated): December 15, 2020
• Study Completion (Anticipated): December 31, 2020

Study Registration Dates

• First Submitted: March 23, 2017
• First Submitted That Met QC Criteria: April 11, 2017
• First Posted (Actual): April 12, 2017

Study Record Updates

• Last Update Posted (Actual): April 29, 2019
• Last Update Submitted That Met QC Criteria: April 26, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: Adults; muscle relaxation; deeply anesthetized; ideal surgical exposure
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Paralysis; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Enzyme Inhibitors; Adjuvants, Anesthesia; Cholinesterase Inhibitors; Parasympathomimetics; Glycopyrrolate; Neostigmine
• Other Study ID Numbers: 1610312153

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: no plan to share IPD

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No