NCT01687894

Brief Summary

Patients undergoing surgery in beach chair position (BCP) are at risk for cerebral ischaemia. The impacts of arginine vasopressin (AVP) on haemodynamics and cerebral oxygenation are evaluated during surgery in BCP.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
74

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2012

Typical duration for all trials

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

May 1, 2012

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 8, 2012

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 19, 2012

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

February 27, 2017

Status Verified

September 1, 2012

Enrollment Period

1.9 years

First QC Date

September 8, 2012

Last Update Submit

February 23, 2017

Conditions

Rotator Cuff Tear Arthropathy

Keywords

cerebral oxygen saturationbeach chair positionhemodynamicjugular venous oximetry

Outcome Measures

Primary Outcomes (1)

  • The magnitude of decrease of mean arterial pressure

    Continuously measure mean arterial blood pressure before and after position change. Calculate the magnitude of maximum decrease of mean arterial pressure from baseline

    Baseline (before positioning) and lowest value within 10 min into beach chair position

Secondary Outcomes (1)

  • Jugular venous oxygen desaturation

    Up to 30 min after the positioning

Other Outcomes (1)

  • Cerebral oxygen desaturation

    Up to 30 min after the position change

Study Arms (4)

Vasopressins & propofol

Administer vasopressin 0.05 or 0.07 IU/kg before sitting position during propofol anesthesia.

Drug: VasopressinsDrug: propofol

Placebo & propofol

Administer saline 10 ml (placebo) 2 min before beach chair position during propofol anesthesia

Drug: PlaceboDrug: propofol

Vasopressins & sevoflurane

Administer vasopressin 0.05 or 0.07 IU/kg 2 min before beach chair position during sevoflurane anesthesia

Drug: VasopressinsDrug: sevoflurane

Placebo & sevoflurane

Placebo (saline 10 ml) for vasopressin is administered 2 min before beach chair position during sevoflurane anesthesia

Drug: PlaceboDrug: sevoflurane

Interventions

VasopressinsDRUG

Vasopressins propofol vasopressins sevoflurane

Also known as: Arginine vasopressin
Vasopressins & propofolVasopressins & sevoflurane
PlaceboDRUG

Placebo propofol \& placebo sevoflurane

Also known as: saline 10 ml as placebo
Placebo & propofolPlacebo & sevoflurane
propofolDRUG

vasopressin propofol \& placebo propofol

Also known as: Intravenous anesthetic
Placebo & propofolVasopressins & propofol
sevofluraneDRUG

vasopressins sevoflurane placebo sevoflurane

Also known as: general anesthetic
Placebo & sevofluraneVasopressins & sevoflurane

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing shoulder surgery in the beach chair position under the general anesthesia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesiology and Pain Medicine

Gwangju, 501-757, South Korea

Location

Related Publications (1)

  • Jang EA, Song JA, Shin JY, Yoon JJ, Yoo KY, Jeong S. Background anaesthetic agents do not influence the impact of arginine vasopressin on haemodynamic states and cerebral oxygenation during shoulder surgery in the beach chair position: a prospective, single-blind study. BMC Anesthesiol. 2017 May 30;17(1):73. doi: 10.1186/s12871-017-0364-9.

    PMID: 28558702DERIVED

MeSH Terms

Conditions

Rotator Cuff Tear Arthropathy

Interventions

VasopressinsArginine VasopressinSodium ChloridePropofolAnesthetics, IntravenousSevofluraneAnesthetics, General

Condition Hierarchy (Ancestors)

ChondrocalcinosisArthritisJoint DiseasesMusculoskeletal DiseasesCrystal Arthropathies

Intervention Hierarchy (Ancestors)

Pituitary Hormones, PosteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsOligopeptidesNerve Tissue ProteinsProteinsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium CompoundsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsAnestheticsCentral Nervous System DepressantsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesCentral Nervous System AgentsTherapeutic UsesMethyl EthersEthersHydrocarbons, FluorinatedHydrocarbons, Halogenated

Study Officials

  • Kyung Y Yoo, M.D.,Ph.D

    Department of Anesthesiology and Pain Medicine, Chonnam National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 8, 2012

First Posted

September 19, 2012

Study Start

May 1, 2012

Primary Completion

April 1, 2014

Study Completion

December 1, 2014

Last Updated

February 27, 2017

Record last verified: 2012-09

Locations

KR(1)