Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 58 of 185 for:    GLYCOPYRROLATE

Use of Sugammadex for Reversal of Paralysis in Microlaryngoscopy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03111121
Recruitment Status : Recruiting
First Posted : April 12, 2017
Last Update Posted : April 29, 2019
Sponsor:
Information provided by (Responsible Party):
Pavithra Ranganathan, West Virginia University

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

Condition or disease Intervention/treatment Phase
Microlaryngoscopy Rigid Bronchoscopy Drug: Sugammadex Drug: neostigmine Drug: glycopyrrolate Phase 4

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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: Single (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.
Primary Purpose: Treatment
Official Title: Use of Sugammadex for Reversal of Paralysis in Microlaryngoscopy
Actual Study Start Date : May 4, 2017
Estimated Primary Completion Date : December 15, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Paralysis

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




Primary Outcome Measures :
  1. Time to extubation after end of procedure [ Time Frame: 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
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.

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03111121


Contacts
Layout table for location contacts
Contact: Pavithra Ranganathan, MD 304-598-4929 ranganathanp@wvumedicine.org
Contact: Connie Tennant, RN, CCRP 304-598-4737 cstennant@hsc.wvu.edu

Locations
Layout table for location information
United States, West Virginia
WVU Healthcare Ruby Memorial Hospital Recruiting
Morgantown, West Virginia, United States, 26506
Contact: Pavithra Ranganathan, MD    304-598-4929    ranganathanp@wvuhealthcare.com   
Contact: Matthew Ellison, MD    304-598-4929    EllisonMa@wvuhealthcare.com   
Principal Investigator: Pavithra Ranganathan, MD         
Sub-Investigator: Matthew Ellison, MD         
Sponsors and Collaborators
West Virginia University

Layout table for additonal information
Responsible Party: Pavithra Ranganathan, Associate Professor, West Virginia University
ClinicalTrials.gov Identifier: NCT03111121     History of Changes
Other Study ID Numbers: 1610312153
First Posted: April 12, 2017    Key Record Dates
Last Update Posted: April 29, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: no plan to share IPD

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pavithra Ranganathan, West Virginia University:
deeply anesthetized
ideal surgical exposure
muscle relaxation
Adults
Additional relevant MeSH terms:
Layout table for MeSH terms
Glycopyrrolate
Paralysis
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neostigmine
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Parasympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Muscarinic Antagonists
Cholinergic Antagonists