Obstructive Sleep Apnea Clinical Trial
Official title:
Sugammadex Compared With Neostigmin/Atropin for Neuromuscular Block Reversal in Patients With Obstructive Sleep Apnea
Incomplete recovery of neuromuscular function after surgery can lead to respiratory
complications. Patients with obstructive sleep apnea (OSA) are prone to respiratory
complications after surgery. Neostigmin and sugammadex are used for neuromuscular reversal.
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
This prospective double blind controlled study will be conducted after obtaining informed
written patient consent.
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
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
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