Sugammadex Compared With Neostigmin/Atropin for Neuromuscular Block Reversal in Patients With Obstructive Sleep Apnea
Condition: Obstructive Sleep Apnea
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional
Phase: Phase 4

Summary: 
      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
    

Detailed description: 
      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
    

Intervention name(s): Sugammadex; Neostigmine
Intervention type(s): Drug; Drug
Intervention description(s): Group S patients will receive 2 mg kg -1 sugammadex at he end of surgery; Patient in Gropu N will receive 50 µg kg-1 neostigmin and 05 mg atropin at the end of surgery
Intervention MeSH terms: Neostigmine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: sugammadex; neostigmine; obstructive sleep apnea