NCT02160223

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2012

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

June 8, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 10, 2014

Completed
Last Updated

December 9, 2014

Status Verified

January 1, 2012

Enrollment Period

2.4 years

First QC Date

June 8, 2014

Last Update Submit

December 7, 2014

Conditions

Obstructive Sleep Apnea

Keywords

sugammadexneostigmineobstructive sleep apnea

Outcome Measures

Primary Outcomes (1)

  • TOF0.9 time

    TOF 0.9 time will be recorded form the TOF watch after the study drug administration

    postoperative 5 minutes

Secondary Outcomes (3)

  • desaturation

    postoperative 5 minutes

  • bradycardia

    postoperative 5 minutes

  • tachycardia

    postoperative 5 minutes

Other Outcomes (2)

  • operation room time

    postoperative 30 minutes

  • PACU time

    poastoperative 1 hour

Study Arms (2)

Sugammadex

EXPERIMENTAL

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

Drug: Sugammadex

Neostigmine

ACTIVE COMPARATOR

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

Drug: Neostigmine

Interventions

SugammadexDRUG

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

Sugammadex
NeostigmineDRUG

Patient in Gropu N will receive 50 µg kg-1 neostigmin and 05 mg atropin at the end of surgery

Neostigmine

Eligibility Criteria

Age19 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ASA I-III Schedulled for surgery for obstructive sleep apnea -

You may not qualify if:

  • Neurouscular disorders hepatic or renal dysfunction allergy to study drugs using medication that could interfere with NMBAs pregnancy breasth feeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Diskapi Yildirim Beyazit Teaching and Research Hospital

Ankara, Turkey (Türkiye)

Location

Related Publications (3)

  • 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.

    PMID: 18946293BACKGROUND

  • 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.

    PMID: 19713265BACKGROUND

  • 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.

    PMID: 21868464BACKGROUND

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

SugammadexNeostigmine

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Intervention Hierarchy (Ancestors)

gamma-CyclodextrinsCyclodextrinsMacrocyclic CompoundsPolycyclic CompoundsDextrinsStarchGlucansPolysaccharidesCarbohydratesPhenylammonium CompoundsQuaternary Ammonium CompoundsAminesOrganic ChemicalsOnium Compounds

Study Officials

  • Dilek yazicioglu, Dr

    Dişkapı yildirim beyazit Teaching and Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

June 8, 2014

First Posted

June 10, 2014

Study Start

January 1, 2012

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

December 9, 2014

Record last verified: 2012-01

Locations

TU(1)