Sugammadex Compared With Neostigmin/Atropin for Neuromuscular Block Reversal in Patients With Obstructive Sleep Apnea
Primary Purpose
Obstructive Sleep Apnea
Status
Completed
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Sugammadex
Neostigmine
Sponsored by
About this trial
This is an interventional treatment trial for Obstructive Sleep Apnea focused on measuring sugammadex, neostigmine, obstructive sleep apnea
Eligibility Criteria
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
-
Sites / Locations
- Diskapi Yildirim Beyazit Teaching and Research Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Sugammadex
Neostigmine
Arm Description
Group S patients will receive 2 mg kg -1 sugammadex at the end of surgery
Group N patients will receive 50 µg kg-1 neostigmine and 05 mg atropin at the end of surgery
Outcomes
Primary Outcome Measures
TOF0.9 time
TOF 0.9 time will be recorded form the TOF watch after the study drug administration
Secondary Outcome Measures
desaturation
patients will be monitored for desaturation after extubation
bradycardia
heart rate will bw monitored after extubation
tachycardia
heart rate will be monitored after extubation
Full Information
NCT ID
NCT02160223
First Posted
June 8, 2014
Last Updated
December 7, 2014
Sponsor
Diskapi Teaching and Research Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02160223
Brief Title
Sugammadex Compared With Neostigmin/Atropin for Neuromuscular Block Reversal in Patients With Obstructive Sleep Apnea
Official Title
Sugammadex Compared With Neostigmin/Atropin for Neuromuscular Block Reversal in Patients With Obstructive Sleep Apnea
Study Type
Interventional
2. Study Status
Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Diskapi Teaching and Research Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea
Keywords
sugammadex, neostigmine, obstructive sleep apnea
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
74 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sugammadex
Arm Type
Experimental
Arm Description
Group S patients will receive 2 mg kg -1 sugammadex at the end of surgery
Arm Title
Neostigmine
Arm Type
Active Comparator
Arm Description
Group N patients will receive 50 µg kg-1 neostigmine and 05 mg atropin at the end of surgery
Intervention Type
Drug
Intervention Name(s)
Sugammadex
Intervention Description
Group S patients will receive 2 mg kg -1 sugammadex at he end of surgery
Intervention Type
Drug
Intervention Name(s)
Neostigmine
Intervention Description
Patient in Gropu N will receive 50 µg kg-1 neostigmin and 05 mg atropin at the end of surgery
Primary Outcome Measure Information:
Title
TOF0.9 time
Description
TOF 0.9 time will be recorded form the TOF watch after the study drug administration
Time Frame
postoperative 5 minutes
Secondary Outcome Measure Information:
Title
desaturation
Description
patients will be monitored for desaturation after extubation
Time Frame
postoperative 5 minutes
Title
bradycardia
Description
heart rate will bw monitored after extubation
Time Frame
postoperative 5 minutes
Title
tachycardia
Description
heart rate will be monitored after extubation
Time Frame
postoperative 5 minutes
Other Pre-specified Outcome Measures:
Title
operation room time
Description
the time elapsed from the study drug administration to the the time the patient was transfered to the PACU
Time Frame
postoperative 30 minutes
Title
PACU time
Description
time elapsed from the the patient entering the PACU to the time the patient left the PACU
Time Frame
poastoperative 1 hour
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dilek yazicioglu, Dr
Organizational Affiliation
Dişkapı yildirim beyazit Teaching and Research Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Diskapi Yildirim Beyazit Teaching and Research Hospital
City
Ankara
Country
Turkey
12. IPD Sharing Statement
Citations:
PubMed Identifier
18946293
Citation
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.
Results Reference
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PubMed Identifier
19713265
Citation
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.
Results Reference
background
PubMed Identifier
21868464
Citation
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.
Results Reference
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Sugammadex Compared With Neostigmin/Atropin for Neuromuscular Block Reversal in Patients With Obstructive Sleep Apnea
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