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

December 7, 2014 updated by: DILEK YAZICIOGLU, Diskapi Teaching and Research Hospital

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

74

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey
        • Diskapi Yildirim Beyazit Teaching and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
TOF0.9 time
Time Frame: postoperative 5 minutes
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
Time Frame: postoperative 5 minutes
patients will be monitored for desaturation after extubation
postoperative 5 minutes
bradycardia
Time Frame: postoperative 5 minutes
heart rate will bw monitored after extubation
postoperative 5 minutes
tachycardia
Time Frame: postoperative 5 minutes
heart rate will be monitored after extubation
postoperative 5 minutes

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
postoperative 30 minutes
PACU time
Time Frame: poastoperative 1 hour
time elapsed from the the patient entering the PACU to the time the patient left the PACU
poastoperative 1 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Diskapi Teaching and Research Hospital

Investigators

  • Principal Investigator: Dilek yazicioglu, Dr, Dişkapı yildirim beyazit Teaching and Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

June 8, 2014

First Submitted That Met QC Criteria

June 8, 2014

First Posted (Estimate)

June 10, 2014

Study Record Updates

Last Update Posted (Estimate)

December 9, 2014

Last Update Submitted That Met QC Criteria

December 7, 2014

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Sugammadex-OSA

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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