Sugammadex Compared With Neostigmin/Atropin for Neuromuscular Block Reversal in Patients With Obstructive Sleep Apnea
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|ClinicalTrials.gov Identifier: NCT02160223|
Recruitment Status : Completed
First Posted : June 10, 2014
Last Update Posted : December 9, 2014
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
|Condition or disease||Intervention/treatment||Phase|
|Obstructive Sleep Apnea||Drug: Sugammadex Drug: Neostigmine||Phase 4|
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
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||74 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Sugammadex Compared With Neostigmin/Atropin for Neuromuscular Block Reversal in Patients With Obstructive Sleep Apnea|
|Study Start Date :||January 2012|
|Actual Primary Completion Date :||June 2014|
|Actual Study Completion Date :||June 2014|
Group S patients will receive 2 mg kg -1 sugammadex at the end of surgery
Group S patients will receive 2 mg kg -1 sugammadex at he end of surgery
Active Comparator: Neostigmine
Group N patients will receive 50 µg kg-1 neostigmine and 05 mg atropin at the end of surgery
Patient in Gropu N will receive 50 µg kg-1 neostigmin and 05 mg atropin at the end of surgery
- TOF0.9 time [ Time Frame: postoperative 5 minutes ]TOF 0.9 time will be recorded form the TOF watch after the study drug administration
- desaturation [ Time Frame: postoperative 5 minutes ]patients will be monitored for desaturation after extubation
- bradycardia [ Time Frame: postoperative 5 minutes ]heart rate will bw monitored after extubation
- tachycardia [ Time Frame: postoperative 5 minutes ]heart rate will be monitored after extubation
- operation room time [ Time Frame: postoperative 30 minutes ]the time elapsed from the study drug administration to the the time the patient was transfered to the PACU
- PACU time [ Time Frame: poastoperative 1 hour ]time elapsed from the the patient entering the PACU to the time the patient left the PACU
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02160223
|Diskapi Yildirim Beyazit Teaching and Research Hospital|
|Principal Investigator:||Dilek yazicioglu, Dr||Dişkapı yildirim beyazit Teaching and Research Hospital|