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Sugammadex on Remifentanil Ce for Preventing Emergence Cough

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ClinicalTrials.gov Identifier: NCT03583021
Recruitment Status : Recruiting
First Posted : July 11, 2018
Last Update Posted : July 12, 2018
Sponsor:
Information provided by (Responsible Party):
Ji Eun Kim, Ajou University School of Medicine

Tracking Information
First Submitted Date  ICMJE June 28, 2018
First Posted Date  ICMJE July 11, 2018
Last Update Posted Date July 12, 2018
Actual Study Start Date  ICMJE June 25, 2018
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 10, 2018)
optimal Ce of remifentanil [ Time Frame: from the ene of surgery until endotracheal extubation ]
Using Dixon methods, evaluating of optimal Ce of remifentanil for preventing emergence cough following extubation during general anesthesia
Original Primary Outcome Measures  ICMJE
 (submitted: June 28, 2018)
optimal Ce of remifentanil for preventing emergence cough following extubation during general anesthesia [ Time Frame: from the ene of surgery until endotracheal extubation ]
Change History Complete list of historical versions of study NCT03583021 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Sugammadex on Remifentanil Ce for Preventing Emergence Cough
Official Title  ICMJE Department of Anesthesiology and Pain Medicine, Ajou University School of Medicine
Brief Summary The primary purpose of this study is to investigate the optimal Ce of remifentanil for preventing emergence cough following extubation during general anesthesia in patients who are reversed with sugammadex or neostigmine.
Detailed Description Remifentanil is a potent ultrashort-acting opioid, with rapid onset and offset of drug effect. It allows rapid anesthetic emergence even after a prolonged infusion, and decreases the at-risk time during extubation. In addition, cough suppression of remifentanil enables smooth extubation with reduced complications. However, the infusion of remifentanil suppresses the emergence cough effectively in clinical practice, whereas it still delays the awakening from anesthesia, resulting in prolonged emergence time. Reduced Ce of remifentanil during emergence would decrease the adverse events that are associated with remifentanil infusion.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Prevention
Condition  ICMJE Gallbladder Diseases
Intervention  ICMJE
  • Drug: Sugammadex Injectable Product
    Sugammadex of 3 mg/kg is injected.
  • Drug: Neostigmine Injectable Product
    Neostigmine of 50 ug/kg and Glycopyrrolate of 10 ug/kg are injected.
Study Arms  ICMJE
  • Experimental: sugammadex group
    Sugammadex group receives the intravenous sugammadex of 3 mg/kg.
    Intervention: Drug: Sugammadex Injectable Product
  • Placebo Comparator: neostigmine group
    Neostigmine group receives the intravenous neostigmine 50 ug/kg and glycopyrrolate 10 ug/kg.
    Intervention: Drug: Neostigmine Injectable Product
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: June 28, 2018)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2019
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Laparoscopic cholecystectomy under general anesthesia

Exclusion Criteria:

  • BMI > 30 kg/m2, respiratory infection, uncontrolled hypertension
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 65 Years to 80 Years   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Ji Eun Kim 82-31-219-5575 beye98@aumc.a.ckr
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03583021
Other Study ID Numbers  ICMJE AJIRB-MED-OBS-18-105
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ji Eun Kim, Ajou University School of Medicine
Study Sponsor  ICMJE Ajou University School of Medicine
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ji Eun Kim Ajou University School of Medicine
PRS Account Ajou University School of Medicine
Verification Date July 2018

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