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Use of Sugammadex for Reversal of Paralysis in Microlaryngoscopy

Primary Purpose

Microlaryngoscopy, Rigid Bronchoscopy

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Sugammadex
neostigmine
glycopyrrolate
Sponsored by
West Virginia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Microlaryngoscopy focused on measuring deeply anesthetized, ideal surgical exposure, muscle relaxation, Adults

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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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Sites / Locations

  • WVU Healthcare Ruby Memorial HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Group 1

Group 2

Arm Description

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)

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
March 23, 2017
Last Updated
April 26, 2019
Sponsor
West Virginia University
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1. Study Identification

Unique Protocol Identification Number
NCT03111121
Brief Title
Use of Sugammadex for Reversal of Paralysis in Microlaryngoscopy
Official Title
Use of Sugammadex for Reversal of Paralysis in Microlaryngoscopy
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Recruiting
Study Start Date
May 4, 2017 (Actual)
Primary Completion Date
December 15, 2020 (Anticipated)
Study Completion Date
December 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
West Virginia University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Microlaryngoscopy, Rigid Bronchoscopy
Keywords
deeply anesthetized, ideal surgical exposure, muscle relaxation, Adults

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
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
Care Provider
Masking Description
SINGLE BLIND: The nurses in PACU will be the only evaluators of the subject who will be blinded to the two groups. The PACU nurses will evaluate ALDRETE discharge criteria and make a note in the electronic medical records for the subject discharge time from PACU.
Allocation
Randomized
Enrollment
84 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Active Comparator
Arm Description
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)
Arm Title
Group 2
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Sugammadex
Intervention Description
receive reversal with sugammadex 4mg/kg
Intervention Type
Drug
Intervention Name(s)
neostigmine
Intervention Description
receive reversal with neostigmine 0.04 mg/kg
Intervention Type
Drug
Intervention Name(s)
glycopyrrolate
Intervention Description
receive reversal with glycopyrrolate (0.01 mg/kg)
Primary Outcome Measure Information:
Title
Time to extubation after end of procedure
Description
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.
Time Frame
intraoperative

10. Eligibility

Sex
All
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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. -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pavithra Ranganathan, MD
Phone
304-598-4929
Email
ranganathanp@wvumedicine.org
First Name & Middle Initial & Last Name or Official Title & Degree
Connie Tennant, RN, CCRP
Phone
304-598-4737
Email
cstennant@hsc.wvu.edu
Facility Information:
Facility Name
WVU Healthcare Ruby Memorial Hospital
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pavithra Ranganathan, MD
Phone
304-598-4929
Email
ranganathanp@wvuhealthcare.com
First Name & Middle Initial & Last Name & Degree
Matthew Ellison, MD
Phone
304-598-4929
Email
EllisonMa@wvuhealthcare.com
First Name & Middle Initial & Last Name & Degree
Pavithra Ranganathan, MD
First Name & Middle Initial & Last Name & Degree
Matthew Ellison, MD

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
no plan to share IPD

Learn more about this trial

Use of Sugammadex for Reversal of Paralysis in Microlaryngoscopy

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