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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
Sponsor:
Information provided by (Responsible Party):
DILEK YAZICIOGLU, Diskapi Teaching and Research Hospital

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


Condition or disease Intervention/treatment Phase
Obstructive Sleep Apnea Drug: Sugammadex Drug: Neostigmine Phase 4

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 74 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Arm Intervention/treatment
Experimental: Sugammadex
Group S patients will receive 2 mg kg -1 sugammadex at the end of surgery
Drug: Sugammadex
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
Drug: Neostigmine
Patient in Gropu N will receive 50 µg kg-1 neostigmin and 05 mg atropin at the end of surgery




Primary Outcome Measures :
  1. TOF0.9 time [ Time Frame: postoperative 5 minutes ]
    TOF 0.9 time will be recorded form the TOF watch after the study drug administration


Secondary Outcome Measures :
  1. desaturation [ Time Frame: postoperative 5 minutes ]
    patients will be monitored for desaturation after extubation

  2. bradycardia [ Time Frame: postoperative 5 minutes ]
    heart rate will bw monitored after extubation

  3. tachycardia [ Time Frame: postoperative 5 minutes ]
    heart rate will be monitored after extubation


Other Outcome Measures:
  1. 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

  2. PACU time [ Time Frame: poastoperative 1 hour ]
    time elapsed from the the patient entering the PACU to the time the patient left the PACU



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Ages Eligible for Study:   19 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

-


Information from the National Library of Medicine

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


Locations
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Turkey
Diskapi Yildirim Beyazit Teaching and Research Hospital
Ankara, Turkey
Sponsors and Collaborators
Diskapi Teaching and Research Hospital
Investigators
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Principal Investigator: Dilek yazicioglu, Dr Dişkapı yildirim beyazit Teaching and Research Hospital
Publications:
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Responsible Party: DILEK YAZICIOGLU, Dr, Diskapi Teaching and Research Hospital
ClinicalTrials.gov Identifier: NCT02160223    
Other Study ID Numbers: Sugammadex-OSA
First Posted: June 10, 2014    Key Record Dates
Last Update Posted: December 9, 2014
Last Verified: January 2012
Keywords provided by DILEK YAZICIOGLU, Diskapi Teaching and Research Hospital:
sugammadex
neostigmine
obstructive sleep apnea
Additional relevant MeSH terms:
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Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Neostigmine
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Parasympathomimetics
Autonomic Agents
Peripheral Nervous System Agents