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Trial record 26 of 190 for:    GLYCOPYRROLATE

"Low Dose Sugammadex Combined With Neostigmine and Glycopyrrolate Versus Full Dose Sugammadex for Reversal of Rocuronium-induced Neuromuscular Blockade: a Cost Saving Strategy"

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02375217
Recruitment Status : Completed
First Posted : March 2, 2015
Last Update Posted : June 27, 2018
Sponsor:
Information provided by (Responsible Party):
Dr. Marie Awad, American University of Beirut Medical Center

Tracking Information
First Submitted Date  ICMJE February 11, 2015
First Posted Date  ICMJE March 2, 2015
Last Update Posted Date June 27, 2018
Study Start Date  ICMJE October 2014
Actual Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 24, 2015)
TOF ratio of 0.9 [ Time Frame: within 5 minutes ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02375217 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 24, 2015)
  • the time to return of TOF ratio to 0.9 and the time till extubation [ Time Frame: within 10 minutes ]
  • Residual neuro-muscular blockade [ Time Frame: within 10 to 180 mins ]
    Post Anesthesia recovery unit
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 "Low Dose Sugammadex Combined With Neostigmine and Glycopyrrolate Versus Full Dose Sugammadex for Reversal of Rocuronium-induced Neuromuscular Blockade: a Cost Saving Strategy"
Official Title  ICMJE "Low Dose Sugammadex Combined With Neostigmine and Glycopyrrolate Versus Full Dose Sugammadex for Reversal of Rocuronium-induced Neuromuscular Blockade: a Cost Saving Strategy"
Brief Summary Prospective Randomized non inferiority Trial involving adult patients undergoing elective surgery under general anesthesia.56 Patients will be enrolled in 2 groups : full dose sugammadex vs half dose sugammadex for reversal of NMB.
Detailed Description The investigators' aim is to prove that half dose sugammadex in combination with neostigmine 0.05 mg/kg is non-inferior to the recommended dose of sugammadex for the reversal of deep ( absence of Trian of Four response :TOF) or moderate ( TOF 1 or 2 twiches) muscle paralysis in patients undergoing surgery under general anesthesia.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Anesthesia Recovery
Intervention  ICMJE
  • Drug: Sugammadex
    half dose
  • Drug: Sugammadex
    full dose
  • Drug: Neostigmine
    IV = 50mcg/kg
  • Drug: glycopyrrolate
Study Arms  ICMJE
  • Active Comparator: Group 1 : (NS)

    Group 1 Drug combination:

    patients receive half of the recommended dose of sugammadex plus dose of neostigmine"

    1. Sugammadex IV= -1 mg/kg( moderate NMB) or

      • 2 mg/kg (deep NMB)
    2. neostigmine IV = 50mcg/kg
    3. glycopyrrolate 10 mcg/kg
    Interventions:
    • Drug: Sugammadex
    • Drug: Neostigmine
    • Drug: glycopyrrolate
  • Active Comparator: Group 2 : (S)

    patients receive Full recommended dose of sugammadex

    Sugammadex IV= 2mg/kg (Moderate NMB) 4mg/kg ( Deep NMB)

    Intervention: Drug: Sugammadex
Publications * Aouad MT, Alfahel WS, Kaddoum RN, Siddik-Sayyid SM. Half dose sugammadex combined with neostigmine is non-inferior to full dose sugammadex for reversal of rocuronium-induced deep neuromuscular blockade: a cost-saving strategy. BMC Anesthesiol. 2017 Apr 11;17(1):57. doi: 10.1186/s12871-017-0348-9.

*   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 Completed
Actual Enrollment  ICMJE
 (submitted: February 24, 2015)
56
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2015
Actual Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients aged 18-70
  • ASA class I, II, and III
  • undergoing surgery under balanced general anesthesia requiring the use of muscle relaxants throughout the surgery

Exclusion Criteria:

  • patients undergoing emergency surgeries
  • pregnant patients
  • patients with end stage renal disease or chronic kidney disease(GFR less than 60)
  • patients with allergy to sugammadex or who had previous complications or side effects from previous sugammadex administration
  • patients' refusal
  • patients with allergy to recuronium
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Lebanon
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02375217
Other Study ID Numbers  ICMJE ANES.MA.14
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. Marie Awad, American University of Beirut Medical Center
Study Sponsor  ICMJE American University of Beirut Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Marie Mn Aouad,, MD American University of Beirut Medical Center
PRS Account American University of Beirut Medical Center
Verification Date June 2018

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