NCT02634255

Brief Summary

Rocuronium, a nondepolarizing neuromuscular blocking agent, is used in general anesthesia to provide conditions for endotracheal intubating. Recommended dose is 0,6 mg/kg and 90 seconds after intravenous injection, patients can be intubated. Anxiety levels may vary in patients undergoing emergency and elective surgery. Patients undergoing emergency surgery may display exaggerated laryngoscopic responses. The purpose of this study is to investigate the effect of patient anxiety levels on the onset time of rocuronium in terms of anxiety scores and train of four (TOF) 0.1 times.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Dec 2015

Shorter than P25 for phase_3

Status
unknown

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

December 1, 2015

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

December 12, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 18, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

December 18, 2015

Status Verified

December 1, 2015

Enrollment Period

5 months

First QC Date

December 12, 2015

Last Update Submit

December 15, 2015

Conditions

Inguinal HerniaAcute Appendicitis

Keywords

rocuroniumonset timeanxiety

Outcome Measures

Primary Outcomes (2)

  • Train of Four Ratio (TOF 0.1)

    90 seconds after induction

  • anxiety score

    15 minutes before induction

Study Arms (2)

Rocuronium elective surgery

ACTIVE COMPARATOR

patients undergoing inguinal herniorrhaphy

Drug: Rocuronium elective surgeryDrug: PropofolDrug: FentanylOther: Ringer LactateDevice: Acceleromyography device

Rocuronium emergency surgery

EXPERIMENTAL

patients undergoing appendectomy

Drug: Rocuronium emergency surgeryDrug: PropofolDrug: FentanylOther: Ringer LactateDevice: Acceleromyography device

Interventions

Rocuronium elective surgeryDRUG

Rocuronium onset time in patients undergoing inguinal herniorrhaphy

Also known as: esmeron
Rocuronium elective surgery
Rocuronium emergency surgeryDRUG

Rocuronium onset time in patients undergoing appendectomy

Also known as: esmeron
Rocuronium emergency surgery
PropofolDRUG
Rocuronium elective surgeryRocuronium emergency surgery
FentanylDRUG
Rocuronium elective surgeryRocuronium emergency surgery
Ringer LactateOTHER
Rocuronium elective surgeryRocuronium emergency surgery
Acceleromyography deviceDEVICE
Also known as: TOF Guard Sx
Rocuronium elective surgeryRocuronium emergency surgery

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • BMI 18,5-24,9
  • ASA 1

You may not qualify if:

  • Allergy to used drugs during anesthesia
  • Neuromuscular disease
  • Liver and kidney failure
  • Heart failure
  • Anticipated difficult airway
  • Using aminoglycosides
  • BMI\<18,5 and BMI\>25

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Fuchs-Buder T, Claudius C, Skovgaard LT, Eriksson LI, Mirakhur RK, Viby-Mogensen J; 8th International Neuromuscular Meeting. Good clinical research practice in pharmacodynamic studies of neuromuscular blocking agents II: the Stockholm revision. Acta Anaesthesiol Scand. 2007 Aug;51(7):789-808. doi: 10.1111/j.1399-6576.2007.01352.x.

    PMID: 17635389BACKGROUND

  • Kain ZN, Mayes LC, Cicchetti DV, Bagnall AL, Finley JD, Hofstadter MB. The Yale Preoperative Anxiety Scale: how does it compare with a "gold standard"? Anesth Analg. 1997 Oct;85(4):783-8. doi: 10.1097/00000539-199710000-00012.

    PMID: 9322455BACKGROUND

  • Plaud B, Debaene B, Donati F. The corrugator supercilii, not the orbicularis oculi, reflects rocuronium neuromuscular blockade at the laryngeal adductor muscles. Anesthesiology. 2001 Jul;95(1):96-101. doi: 10.1097/00000542-200107000-00019.

    PMID: 11465590BACKGROUND

MeSH Terms

Conditions

Hernia, InguinalAppendicitisAnxiety Disorders

Interventions

RocuroniumPropofolFentanylRinger's Lactate

Condition Hierarchy (Ancestors)

Hernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsIntraabdominal InfectionsInfectionsGastroenteritisGastrointestinal DiseasesDigestive System DiseasesCecal DiseasesIntestinal DiseasesMental Disorders

Intervention Hierarchy (Ancestors)

AndrostanolsAndrostanesSteroidsFused-Ring CompoundsPolycyclic CompoundsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Murat Sayın, Assoc Prof

    Diskapi Yildirim Beyazit Education and Research Hospital

    STUDY CHAIR

Central Study Contacts

Gamze Gulgun, Md

CONTACT

+905308705073dr.gamzegulgun@yahoo.com

Dilek Yazicioglu, Md

CONTACT

+905336957855dilek.yazicioglu@hotmail.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Md

Study Record Dates

First Submitted

December 12, 2015

First Posted

December 18, 2015

Study Start

December 1, 2015

Primary Completion

May 1, 2016

Study Completion

July 1, 2016

Last Updated

December 18, 2015

Record last verified: 2015-12