Sugammadex Compared With Neostigmin/Atropin for Neuromuscular Block Reversal in Patients With Obstructive Sleep Apnea

Study Overview
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Brief Summary
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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
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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

Official Title
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Sugammadex Compared With Neostigmin/Atropin for Neuromuscular Block Reversal in Patients With Obstructive Sleep Apnea

Conditions
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Obstructive Sleep Apnea

Intervention / Treatment
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* Drug: Sugammadex
* Drug: Neostigmine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ASA I-III Schedulled for surgery for obstructive sleep apnea - Exclusion Criteria: Neurouscular disorders hepatic or renal dysfunction allergy to study drugs using medication that could interfere with NMBAs pregnancy breasth feeding -

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sugammadex<br>Group S patients will receive 2 mg kg -1 sugammadex at the end of surgery | Drug: Sugammadex<br>* Group S patients will receive 2 mg kg -1 sugammadex at he end of surgery<br>|
| Active Comparator: Neostigmine<br>Group N patients will receive 50 µg kg-1 neostigmine and 05 mg atropin at the end of surgery | Drug: Neostigmine<br>* Patient in Gropu N will receive 50 µg kg-1 neostigmin and 05 mg atropin at the end of surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TOF0.9 time | TOF 0.9 time will be recorded form the TOF watch after the study drug administration | postoperative 5 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| desaturation | patients will be monitored for desaturation after extubation | postoperative 5 minutes | 
| bradycardia | heart rate will bw monitored after extubation | postoperative 5 minutes | 
| tachycardia | heart rate will be monitored after extubation | postoperative 5 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sugammadex, neostigmine, obstructive sleep apnea