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Trial record 1 of 1 for:    NCT 02375217
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"Low Dose Sugammadex Combined With Neostigmine and Glycopyrrolate Versus Full Dose Sugammadex for Reversal of Rocuronium-induced Neuromuscular Blockade: a Cost Saving Strategy"

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2015 by Dr. Marie Awad, American University of Beirut Medical Center.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT02375217
First Posted: March 2, 2015
Last Update Posted: March 2, 2015
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.
Information provided by (Responsible Party):
Dr. Marie Awad, American University of Beirut Medical Center
  Purpose
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.

Condition Intervention Phase
Anesthesia Recovery Drug: Sugammadex Drug: Neostigmine Drug: glycopyrrolate Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: "Low Dose Sugammadex Combined With Neostigmine and Glycopyrrolate Versus Full Dose Sugammadex for Reversal of Rocuronium-induced Neuromuscular Blockade: a Cost Saving Strategy"

Resource links provided by NLM:


Further study details as provided by Dr. Marie Awad, American University of Beirut Medical Center:

Primary Outcome Measures:
  • TOF ratio of 0.9 [ Time Frame: within 5 minutes ]

Secondary Outcome Measures:
  • 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


Estimated Enrollment: 56
Study Start Date: October 2014
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Drug: Sugammadex
half dose
Drug: Neostigmine
IV = 50mcg/kg
Drug: glycopyrrolate
Active Comparator: Group 2 : (S)

patients receive Full recommended dose of sugammadex

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

Drug: Sugammadex
full dose

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
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): NCT02375217


Contacts
Contact: Marie Mn Aouad,, MD 961 1350000 ext 6380/1 mm01@aub.edu.lb

Locations
Lebanon
AUBMC Recruiting
Beirut, Lebanon
Contact: Marie Aouad, MD         
Sponsors and Collaborators
American University of Beirut Medical Center
Investigators
Principal Investigator: Marie Mn Aouad,, MD American University of Beirut Medical Center
  More Information

Responsible Party: Dr. Marie Awad, Professor of clinical Specialty, American University of Beirut Medical Center
ClinicalTrials.gov Identifier: NCT02375217     History of Changes
Other Study ID Numbers: ANES.MA.14
First Submitted: February 11, 2015
First Posted: March 2, 2015
Last Update Posted: March 2, 2015
Last Verified: February 2015

Additional relevant MeSH terms:
Rocuronium
Neostigmine
Glycopyrrolate
Neuromuscular Nondepolarizing Agents
Neuromuscular Blocking Agents
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Parasympathomimetics
Autonomic Agents
Adjuvants, Anesthesia
Muscarinic Antagonists
Cholinergic Antagonists