Trial record 1 of 1 for:
"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
Information provided by (Responsible Party):
Dr. Marie Awad, American University of Beirut Medical Center
First received: February 11, 2015
Last updated: February 24, 2015
Last verified: February 2015
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.
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
||"Low Dose Sugammadex Combined With Neostigmine and Glycopyrrolate Versus Full Dose Sugammadex for Reversal of Rocuronium-induced Neuromuscular Blockade: a Cost Saving Strategy"
Primary Outcome Measures:
- TOF ratio of 0.9 [ Time Frame: within 5 minutes ]
Secondary Outcome Measures:
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||October 2015 (Final data collection date for primary outcome measure)
Active Comparator: Group 1 : (NS)
Group 1 Drug combination:
patients receive half of the recommended dose of sugammadex plus dose of neostigmine"
Sugammadex IV= -1 mg/kg( moderate NMB) or
- neostigmine IV = 50mcg/kg
- glycopyrrolate 10 mcg/kg
IV = 50mcg/kg
Active Comparator: Group 2 : (S)
patients receive Full recommended dose of sugammadex
Sugammadex IV= 2mg/kg (Moderate NMB) 4mg/kg ( Deep NMB)
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.
|Ages Eligible for Study:
||18 Years to 70 Years (Adult, Senior)
|Sexes Eligible for Study:
|Accepts Healthy Volunteers:
- 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
- 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT02375217
|Beirut, Lebanon |
|Contact: Marie Aouad, MD |
American University of Beirut Medical Center
||Marie Mn Aouad,, MD
||American University of Beirut Medical Center
||Dr. Marie Awad, Professor of clinical Specialty, American University of Beirut Medical Center
History of Changes
|Other Study ID Numbers:
|Study First Received:
||February 11, 2015
||February 24, 2015
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on July 25, 2017
Neuromuscular Nondepolarizing Agents
Neuromuscular Blocking Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Molecular Mechanisms of Pharmacological Action