Sugammadex Compared With Neostigmin/Atropin for Neuromuscular Block Reversal in Patients With Obstructive Sleep Apnea
NCT ID: NCT02160223
Last Updated: 2014-12-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
74 participants
INTERVENTIONAL
2012-01-31
2014-06-30
Brief Summary
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The aim of this study was to compare sugammadex and neostigmin regarding efficacy, incidence of respiratory complications and cost in patients undergoing surgery for OSA
Detailed Description
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Simple randomization will be accomplished with a computer-generated sequence of numbers and sealed envelopes will be used to allocate patients into 2 groups.
Group N will receive 50 µg kg-1 neostigmin,+05 mg atropin Group S will receive sugammadex 2mg kg-1 sugammadex at the and of surgery. Patients will enter the operation room without receiving premedication Heart rate, noninvasive blood pressures, body temperature, BIS, end-tidal respiratory gases and neuromuscular function (acceleromyography) will be monitored Propofol will be used for anesthesia induction Rocuronium 0.6 mg kg-1 will be used to facilitate intubation Anesthesia will be maintained with sevoflurane in oxygen and nitrous oxide, BIS will be maintainen between 40-60 Additional rocuronium doses will be administered when the TOF T2 is observed At the end of surgery, volatile anesthesia will be discontinued, the study drug will be administered according to group allocation and the TOF response at this time will be recorded Time to obtain TOF0.9 will be recorded Time to extubation, time to recovery, time spent in the operation room will be recorded Respiratory and cardiovascular complications (bradycardia, tachycardia, hypertention, ritmia, bronchospasm, laringospasm, breath holding, cough, desaturation, hypoxia, NIMV, reintubation) and treatments during anesthesia emergence will be recorded Patients will be transfered to the PACU, time spent in PACU and respiratory and cardiovascular complications (bradycardia, tachycardia, hypertention, ritmia, bronchospasm, laringospasm, breath holding, cough, desaturation, hypoxia, NIMV, reintubation) and treatments during PACU stay will be recorded After achieving an Aldrete score \>9 patients will be transfered to the ward. Patients who can not achieve Aldrete score \>9 after 1 hour will be transfered to the ICU.
Respiratory and cardiovascular complications and treatments in the ICU will be recored
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Sugammadex
Group S patients will receive 2 mg kg -1 sugammadex at the end of surgery
Sugammadex
Group S patients will receive 2 mg kg -1 sugammadex at he end of surgery
Neostigmine
Group N patients will receive 50 µg kg-1 neostigmine and 05 mg atropin at the end of surgery
Neostigmine
Patient in Gropu N will receive 50 µg kg-1 neostigmin and 05 mg atropin at the end of surgery
Interventions
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Sugammadex
Group S patients will receive 2 mg kg -1 sugammadex at he end of surgery
Neostigmine
Patient in Gropu N will receive 50 µg kg-1 neostigmin and 05 mg atropin at the end of surgery
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
\-
19 Years
70 Years
ALL
No
Sponsors
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Diskapi Teaching and Research Hospital
OTHER
Responsible Party
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DILEK YAZICIOGLU
Dr
Principal Investigators
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Dilek yazicioglu, Dr
Role: PRINCIPAL_INVESTIGATOR
Dişkapı yildirim beyazit Teaching and Research Hospital
Locations
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Diskapi Yildirim Beyazit Teaching and Research Hospital
Ankara, , Turkey (Türkiye)
Countries
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References
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Jones RK, Caldwell JE, Brull SJ, Soto RG. Reversal of profound rocuronium-induced blockade with sugammadex: a randomized comparison with neostigmine. Anesthesiology. 2008 Nov;109(5):816-24. doi: 10.1097/ALN.0b013e31818a3fee.
Khuenl-Brady KS, Wattwil M, Vanacker BF, Lora-Tamayo JI, Rietbergen H, Alvarez-Gomez JA. Sugammadex provides faster reversal of vecuronium-induced neuromuscular blockade compared with neostigmine: a multicenter, randomized, controlled trial. Anesth Analg. 2010 Jan 1;110(1):64-73. doi: 10.1213/ane.0b013e3181ac53c3. Epub 2009 Aug 27.
Kaw R, Pasupuleti V, Walker E, Ramaswamy A, Foldvary-Schafer N. Postoperative complications in patients with obstructive sleep apnea. Chest. 2012 Feb;141(2):436-441. doi: 10.1378/chest.11-0283. Epub 2011 Aug 25.
Other Identifiers
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Sugammadex-OSA
Identifier Type: -
Identifier Source: org_study_id