NCT01851005

Brief Summary

Emergence of elderly patients from anesthesia may face with cognitive dysfunction or agitation such as delirium. There are reports that using dexmedetomidine as a adjuvant for general anesthesia decreased emergence-agitation in children and dexmedetomidine may be used for treating deliriums. Thus, we thought that dexmedetomidine as a adjuvant agent may be a help to smooth emergence from anesthesia in elderly. The aims of this study were to investigate the recovery characteristics (time to recovery of consciousness (ROC) and recovery, bispectral index (BIS) values at ROC and orientation, and Ricker sedation-agitated scale at the postanesthetic care unit) and safety (vital signs during and after administration of dexmedetomidine) of dexmedetomidine in elderly patients undergoing elective surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2013

Shorter than P25 for not_applicable

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

First Submitted

Initial submission to the registry

April 30, 2013

Completed
1 day until next milestone

Study Start

First participant enrolled

May 1, 2013

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 10, 2013

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
Last Updated

March 19, 2014

Status Verified

March 1, 2014

Enrollment Period

9 months

First QC Date

April 30, 2013

Last Update Submit

March 18, 2014

Conditions

Elderly PatientsAnesthesiaEmergence From AnesthesiaEffects of DexmedetomidineRecovery From Anesthesia

Keywords

DexmedetomidineAnesthesiaRecovery profile

Outcome Measures

Primary Outcomes (1)

  • Recovery time (1)

    Time to eye opening.

    At the end of surgery and anesthesia, an expected average of 15 minutes

Secondary Outcomes (1)

  • Ricker scale

    About 5 minutes after end of surgery and anesthesia

Other Outcomes (2)

  • Side effects

    Participants will be followed for the duration of postanesthetic care unit stay, an expected average of 1 hour

  • Recovery time (2)

    At the end of surgery and anesthesia, an expected average of 15 minutes

Study Arms (4)

Group 1

PLACEBO COMPARATOR

General anesthesia with sevoflurane. Infusion of normal saline during surgery. Administer rocuronium 0.8 mg/kg for induction.

Drug: SevofluraneDrug: Normal salineDrug: Rocuronium

Group 2

PLACEBO COMPARATOR

General anesthesia with propofol and remifentanil. (Total intravenous anesthesia) Infusion of normal saline during surgery. Administer rocuronium 0.8 mg/kg for induction.

Drug: Propofol and RemifentanilDrug: Normal salineDrug: Rocuronium

Group 3

EXPERIMENTAL

General anesthesia with sevoflurane. Infusion of dexmedetomidine (0.4 ug/kg/hr) during anesthesia. Administer rocuronium 0.8 mg/kg for induction.

Drug: DexmedetomidineDrug: SevofluraneDrug: Rocuronium

Group 4

EXPERIMENTAL

General anesthesia with propofol and remifentanil. (Total intravenous anesthesia) Infusion of dexmedetomidine (0.4 ug/kg/hr) during surgery. Administer rocuronium 0.8 mg/kg for induction.

Drug: DexmedetomidineDrug: Propofol and RemifentanilDrug: Rocuronium

Interventions

DexmedetomidineDRUG

Infusion of dexmedetomidine (0.4 ug/kg/hr)

Also known as: Precedex
Group 3Group 4
SevofluraneDRUG

Control Vol% to maintain BIS 40\~45

Also known as: Sevorane
Group 1Group 3
Propofol and RemifentanilDRUG

Control effect site concentration for maintain BIS 40\~45 and changes of vital signs within 20%.

Also known as: Total intravenous anesthesia
Group 2Group 4
Normal salineDRUG

Use as placebo

Also known as: Placebo
Group 1Group 2
RocuroniumDRUG

0.8 mg/kg for induction

Also known as: Muscle relaxation during general anesthesia
Group 1Group 2Group 3Group 4

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • ASA I-II
  • Age \> 65
  • Elective surgery

You may not qualify if:

  • Patients with severe heart disease with New York Heart Association class \> III
  • Patients with severe arrhythmia
  • Patients with uncontrolled hypertension or hypotension
  • Patients with hemodynamic unstably
  • Patients with hypersensitivity with drugs
  • Patients with cognitive deficiency, dementia, or delirium
  • Patients with hepatic or renal compromise
  • Patients with infective disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chosun University Hospital

Gwangju, 501-717, South Korea

Location

Related Publications (5)

  • Juvin P, Servin F, Giraud O, Desmonts JM. Emergence of elderly patients from prolonged desflurane, isoflurane, or propofol anesthesia. Anesth Analg. 1997 Sep;85(3):647-51. doi: 10.1097/00000539-199709000-00029.

    PMID: 9296424BACKGROUND

  • Patel A, Davidson M, Tran MC, Quraishi H, Schoenberg C, Sant M, Lin A, Sun X. Dexmedetomidine infusion for analgesia and prevention of emergence agitation in children with obstructive sleep apnea syndrome undergoing tonsillectomy and adenoidectomy. Anesth Analg. 2010 Oct;111(4):1004-10. doi: 10.1213/ANE.0b013e3181ee82fa. Epub 2010 Aug 12.

    PMID: 20705788BACKGROUND

  • Tei M, Ikeda M, Haraguchi N, Takemasa I, Mizushima T, Ishii H, Yamamoto H, Sekimoto M, Doki Y, Mori M. Risk factors for postoperative delirium in elderly patients with colorectal cancer. Surg Endosc. 2010 Sep;24(9):2135-9. doi: 10.1007/s00464-010-0911-7. Epub 2010 Feb 23.

    PMID: 20177939BACKGROUND

  • Lepouse C, Lautner CA, Liu L, Gomis P, Leon A. Emergence delirium in adults in the post-anaesthesia care unit. Br J Anaesth. 2006 Jun;96(6):747-53. doi: 10.1093/bja/ael094. Epub 2006 May 2.

    PMID: 16670111BACKGROUND

  • Kim DJ, Kim SH, So KY, Jung KT. Effects of dexmedetomidine on smooth emergence from anaesthesia in elderly patients undergoing orthopaedic surgery. BMC Anesthesiol. 2015 Oct 7;15:139. doi: 10.1186/s12871-015-0127-4.

    PMID: 26446479DERIVED

MeSH Terms

Interventions

DexmedetomidineSevofluranePropofolRemifentanilSaline SolutionRocuronium

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsMethyl EthersEthersOrganic ChemicalsHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbonsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicPropionatesAcids, AcyclicCarboxylic AcidsPiperidinesCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical PreparationsAndrostanolsAndrostanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Ki Tae Jung, M.D.

    Department of Anesthesiology and Pain medicine School of Medicine, Chosun University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assist Professor, Principal Investigator, Clinical Professor of Department of Anesthesiology and Pain medicine, School of Medicine, Chosun University

Study Record Dates

First Submitted

April 30, 2013

First Posted

May 10, 2013

Study Start

May 1, 2013

Primary Completion

February 1, 2014

Study Completion

February 1, 2014

Last Updated

March 19, 2014

Record last verified: 2014-03

Locations

KR(1)