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

Diskapi Teaching and Research Hospital

Status and phase: Completed; Phase 4

Conditions: Obstructive Sleep Apnea

Treatments: Drug: Neostigmine; Drug: Sugammadex

Study type: Interventional

Funder types: Other

Identifiers

NCT02160223

Sugammadex-OSA

Details and patient eligibility

About

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

Full 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

Enrollment: 74 patients

Sex: All

Ages: 19 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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74 participants in 2 patient groups

Sugammadex

Experimental group

Description:

Group S patients will receive 2 mg kg -1 sugammadex at the end of surgery

Treatment:

Drug: Sugammadex

Neostigmine

Active Comparator group

Description:

Group N patients will receive 50 µg kg-1 neostigmine and 05 mg atropin at the end of surgery

Treatment:

Drug: Neostigmine