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Trial record 34 of 186 for:    GLYCOPYRROLATE

Sugammadex Versus Neostigmine for Reversal of Rocuronium Neuromuscular

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ClinicalTrials.gov Identifier: NCT03322657
Recruitment Status : Recruiting
First Posted : October 26, 2017
Last Update Posted : February 4, 2019
Sponsor:
Information provided by (Responsible Party):
Ehab Farag, The Cleveland Clinic

Tracking Information
First Submitted Date  ICMJE October 13, 2017
First Posted Date  ICMJE October 26, 2017
Last Update Posted Date February 4, 2019
Actual Study Start Date  ICMJE November 14, 2017
Estimated Primary Completion Date October 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 25, 2017)
Time in minutes to reach train of four (TOF) ratio ≥ 0.9 after the administration of reversal agent [ Time Frame: 90 minutes after endotracheal extubation ]
The TOF ratio twitches ≥ 0.9 will be measured in continuous manner every 12 seconds from the administration of the reversal drug. The TOF ratio will be measured by acceleromyography of the force developed in the adductor pollicis muscle using the TOF scan.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03322657 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 25, 2017)
The time for extubation after administration of reversal agents [ Time Frame: Up to 4 hours after administration of reversal agents ]
Time from administration of reversal agent to tracheal extubation
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Sugammadex Versus Neostigmine for Reversal of Rocuronium Neuromuscular
Official Title  ICMJE Sugammadex Versus Neostigmine for Reversal of Rocuronium Neuromuscular Block in Patients Having Catheter-based Neurointerventional Procedures
Brief Summary The aim of this study is to evaluate whether the use of Sugammadex for reversing the neuromuscular blocking effects of rocuronium during neurointerventional procedures can speed recovery of neuromuscular function. Half of participates will receive Neostigmine with glycopyrrolate, while the other half will receive Sugammadex.
Detailed Description

Incomplete recovery from neuromuscular blocking agents (NMBAs) residual block after anesthesia and surgery continues to be a common problem in the postanesthesia care (PACU).

Neostigmine remains the most common acetylcholinesterase inhibitor in the United States. However, administration of the drug significantly impairs genioglossus muscle activity when administered after full recovery from neuromuscular block. Moreover, doses of neostigmine exceeding 0.06 mg/kg increase the risk of respiratory complications independent of NMBAs effects.

Sugammadex is a modified γ-cyclodextrin that rapidly reverses that effect of the steroidal nondepolarizing NMBAs rocuronium and vecuronium. Sugammadex forms a stable, inactive 1:1 complex with rocuronium or vecuronium, reducing the amount of free NMBA available to bind to nicotinic acetylcholine receptors at the neuromuscular junction. Unlike neostigmine, sugammadex completely reverses even dense neuromuscular blocks.

Patients having catheter-based neurointerventional procedures are kept deeply anesthetized. It is common to find patients nearly completely paralyzed at the end of neurointerventional procedures and have a markedly delayed emergence while waiting for muscle function to recover sufficiently to safely antagonize with neostigmine.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Condition  ICMJE
  • Neuromuscular Blockade
  • Anesthesia
Intervention  ICMJE
  • Drug: Neostigmine
    Neostigmine injection
  • Drug: Glycopyrrolate
    Glycopyrrolate injection
  • Drug: Sugammadex
    Sugammadex injection
Study Arms  ICMJE
  • Active Comparator: Neostigmine with glycopyrrolate
    Neostigmine 0. 07 mg/kg with glycopyrrolate 0.01 mg/kg with ceiling dose of 5 mg neostigmine with 1 mg of glycopyrrolate at the end surgery
    Interventions:
    • Drug: Neostigmine
    • Drug: Glycopyrrolate
  • Experimental: Sugammadex
    Sugammadex 4 mg/kg at the end surgery
    Intervention: Drug: Sugammadex
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 25, 2017)
46
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 30, 2019
Estimated Primary Completion Date October 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age ≥ 18 years;
  • American Society of Anesthesiologists (ASA) physical status 1-3;
  • Scheduled for catheter-based neurointerventional procedures including coiling and stent insertion;
  • General anesthesia.

Exclusion Criteria:

  • Suspected difficult intubation;
  • Neuromuscular disorder;
  • Renal impairment creatinine ≥ 2 mg /dl;
  • Hepatic dysfunction;
  • History of malignant hyperthermia;
  • Allergy to neuromuscular blocking drugs, Sugammadex, neostigmine or glycopyrrolate;
  • Perioperative respiratory infections and/or pneumonia;
  • Intubated or unresponsive;
  • Pregnancy or breastfeeding.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03322657
Other Study ID Numbers  ICMJE 17-764
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ehab Farag, The Cleveland Clinic
Study Sponsor  ICMJE The Cleveland Clinic
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account The Cleveland Clinic
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP