NCT01789385

Brief Summary

Deep brain stimulation for the treatment of Parkinson's disease has unique surgical stages and anesthesia needs. In the first stage the electrodes are inserted in the targeted brain areas and in the second stage the pulse generator is implanted. The technique for establishing sedation and analgesia for functional neurosurgery may differ among institutions. In this study it was aimed to investigate our anesthesia methods, intra-operative adverse events in the first stage of deep brain stimulation and the post operative pain therapy of the patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
26

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Feb 2013

Shorter than P25 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

February 1, 2013

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

February 2, 2013

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 12, 2013

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
Last Updated

May 20, 2014

Status Verified

February 1, 2013

Enrollment Period

2 months

First QC Date

February 2, 2013

Last Update Submit

May 19, 2014

Conditions

Parkinsons Disease

Keywords

Deep brain stimulationParkinson

Outcome Measures

Primary Outcomes (1)

  • Doses of the sedative agents

    Dexmedetomidine, propofol and midazolam will be used for sedation. We will determine the doses needed to tolerate surgery and to allow MER's and macrostimulation

    1 day

Secondary Outcomes (1)

  • Time to emergence

    1 day

Other Outcomes (1)

  • postoperative pain scores

    postopertive 1 day

Study Arms (1)

dexmedetomidine

OTHER

Precedex 200 mcg 2ml

Drug: Dexmedetomidine

Interventions

DexmedetomidineDRUG

Starting with a 1 mg kg-1min-1 loading dose and than continued with a0.2-0.8 mg kg-1h-1 infusion rate.

Also known as: Precedex 200 mcg 2 ml
dexmedetomidine

Eligibility Criteria

Age19 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing DBS for the treatment of PD

You may not qualify if:

  • Patients required general anesthesia,
  • suffered from dementia,
  • obstructive sleep apnea,
  • gastro esophageal reflux and with a mallampati score \> 2,
  • musculoskeletal problems causing difficulty with long term surgical positioning were excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Diskapi Yildirim Beyazit Teaching and Research Hospital

Ankara, Turkey (Türkiye)

Location

Related Publications (3)

  • Genty S, Derrey S, Pouplin S, Lefaucheur R, Chastan N, Gerardin E, Maltete D. Pain due to osteoarthritis may impair the early outcome of deep brain stimulation in Parkinson's disease. Clin Neurol Neurosurg. 2011 Dec;113(10):864-7. doi: 10.1016/j.clineuro.2011.06.006. Epub 2011 Jul 19.

    PMID: 21775052BACKGROUND

  • Yagar S, Yavas S, Karahalil B. The role of the ADRA2A C1291G genetic polymorphism in response to dexmedetomidine on patients undergoing coronary artery surgery. Mol Biol Rep. 2011 Jun;38(5):3383-9. doi: 10.1007/s11033-010-0446-y. Epub 2010 Nov 23.

    PMID: 21104443BACKGROUND

  • Stoneham MD, Cooper R, Quiney NF, Walters FJ. Pain following craniotomy: a preliminary study comparing PCA morphine with intramuscular codeine phosphate. Anaesthesia. 1996 Dec;51(12):1176-8. doi: 10.1111/j.1365-2044.1996.tb15065.x.

    PMID: 9038464RESULT

MeSH Terms

Conditions

Parkinson Disease

Interventions

Dexmedetomidine

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Dilek YAZICIOGLU, MD

    Ankara Diskapi Yildirim Beyazit Teaching and Research Hospital, Turkey.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

February 2, 2013

First Posted

February 12, 2013

Study Start

February 1, 2013

Primary Completion

April 1, 2013

Study Completion

April 1, 2013

Last Updated

May 20, 2014

Record last verified: 2013-02

Locations

TU(1)