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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02375217 |
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Date of registration:
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11/02/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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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"
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Scientific title:
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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" |
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Date of first enrolment:
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October 2014 |
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Target sample size:
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56 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02375217 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
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Phase:
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Phase 4
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Countries of recruitment
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Lebanon
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Contacts
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Name:
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Marie Mn Aouad,, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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American University of Beirut Medical Center |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
70 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Anesthesia Recovery
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Intervention(s)
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Drug: Neostigmine
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Drug: glycopyrrolate
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Drug: Sugammadex
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Primary Outcome(s)
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TOF ratio of 0.9
[Time Frame: within 5 minutes]
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Secondary Outcome(s)
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Residual neuro-muscular blockade
[Time Frame: within 10 to 180 mins]
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the time to return of TOF ratio to 0.9 and the time till extubation
[Time Frame: within 10 minutes]
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Secondary ID(s)
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ANES.MA.14
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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