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Trial record 25 of 186 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"

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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

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.

Condition or disease Intervention/treatment Phase
Anesthesia Recovery Drug: Sugammadex Drug: Neostigmine Drug: glycopyrrolate Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
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"
Study Start Date : October 2014
Actual Primary Completion Date : October 2015
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




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

Secondary Outcome Measures :
  1. the time to return of TOF ratio to 0.9 and the time till extubation [ Time Frame: within 10 minutes ]
  2. Residual neuro-muscular blockade [ Time Frame: within 10 to 180 mins ]
    Post Anesthesia recovery unit



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
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

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


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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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 Posted: March 2, 2015    Key Record Dates
Last Update Posted: June 27, 2018
Last Verified: June 2018
Additional relevant MeSH terms:
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Glycopyrrolate
Rocuronium
Neostigmine
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