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Parkinsons DiseasePhase 4NCT01789385

Anesthesia for Deep Brain Stimulation

A Phase 4 study testing Dexmedetomidine in people with Parkinsons Disease, run by Diskapi Teaching and Research Hospital at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 19 to 85 years
Conditions the study is for
Parkinsons Disease
What is being tested?
Dexmedetomidine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
26 participants
Where
1 siteTurkey (Türkiye)
Study dates
Feb 2013to Apr 2013
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients undergoing DBS for the treatment of PD

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Ankara Diskapi Yildirim Beyazit Teaching and Research Hospital

    Ankara

Other trials in Turkey (Türkiye)

About this study

Official title: Anesthesia for Deep Brain Stimulation for the Treatment of Parkinsons Disease

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.

Read the detailed description

This study included patients underwent deep brain stimulation (DBS) in the treatment of patients with Parkinson disease (PD). After obtaining ethical approval and patient consent, consecutive patients underwent deep brain stimulation with a predetermined anesthesia protocol were studied.

The anesthetic procedure was explained to the patients in detail by the responsible anesthetist. Patients requiring general anesthesia, suffering from dementia, obstructive sleep apnea, gastroesophageal reflux and with a mallampati score>2, musculoskeletal problems causing difficulty with long term surgical positioning were excluded. The following parameters were recorded:Gender, age, body mass index (BMI), ASA classification, co existing diseases, anti Parkinson medications, sedative drugs and doses, level of conscious sedation, local anesthetic agents and doses, total duration of procedure, adverse events and complications, post operative pain therapy.

Preoperative sedation was not administered. At arrival in the operating room patients were monitored for heart rate (HR) non invasive blood pressures (systolic arterial pressure; SAP, diastolic arterial pressure; DAP, mean arterial pressure; MAP) peripheral oxygen saturation (SPO2), respiratory rate (RR), BIS, baseline values were recorded and recordings were continued with 5 min intervals. Urinary catheterization was not applied. Adequate attention was payed to assure all patients to be in a comfortable position. A peripheral intravenous catheter was inserted and Ringers lactate solution was infused 50-100 ml h-1. All patients received oxygen 2 L min-1 via a nasal cannula. Nasal airway, LMA and ET was prepared as rescue airway devices. Periods of SPO2 < 92 and a RR ≤ 8 min were documented. Maneuvers needed to manipulate airway patency was recorded. A 20% difference in the initial hemodynamic parameters and the use of hypotensive or inotrope, vasopressor medications were recorded.

Initial sedation was employed with a 1 mg kg-1min-1 loading dose of dexmedetomidine (Precedex®,Hospira Inc, Rocky Mountain, USA) for 10 minutes. Sedation was maintained with dexmedetomidine at a 0.2-0.8 mg kg-1h-1 infusion rate. Invasive blood pressure monitoring will be applied after sedation is commenced. After achieving an adequate sedation level which is defined as a BIS value of 65-85 and the Ramsay sedation score 3, the scalp block was performed as previously described by Girvin. A superficial cervical plexus block was also performed. Bupivacaine was used for the nerve blocks. Lidocaine was used for local anesthetic scalp infiltration in case of insufficient analgesia was observed during the insertion of the head pins or at any time the patient complained having pain. Ephedrine 1/200000 was added to the local anesthetics. Local anesthetic agents were diluted with equivalent volumes of saline (1/1 volume). The total doses of local anesthetics was recorded at the end of the procedure. Propofol was used with incremental intravenous boluses for rescue sedation when needed and the total dose will be documented. Sedation was discontinued before the micro electrode recordings (MER's) and macro stimulation. Time to emergence was defined as the time between the discontinuation of the sedatives and the time between the patients are able to cooperate with the neurologic examination. All intra-operative events and complications and complaints regarding pain and restlessness were documented. The total duration of the procedure includes initial sedation, performance of regional anesthesia, stereotactic frame insertion, magnetic resonance (MRI) or computerized tomography (CT) imaging, MER's, macro stimulation and closure.

After completion of procedure patients were transferred to the post anesthesia care unit (PACU). Postoperative pain was evaluated in the PACU at arrival and then at 1, 6, 12, 24 h using a 0-10 cm verbal analog scale (VAS)(zero: no pain, 10: maximal pain). Patients received 50 mg tramadol 8 hourly and PCA with morphine(5 mg loading dose, 2 mg bolus, 15 min lockout time) was initiated when the VAS ≥ 3. Morphine consumption was measured at 24 h.

Being tested
Dexmedetomidine
Keywords
Deep brain stimulation, Parkinson
Medical subject headings
Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DexmedetomidineDrug

    Also called Precedex 200 mcg 2 ml

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

Study groups in NCT01789385
Study groupRoleWhat they receive
dexmedetomidineOtherPrecedex 200 mcg 2ml
Receives: Drug: Dexmedetomidine

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 1 day

Secondary outcomes (1)
  1. Time to emergence

    time from discontinuation of sedative drugs to time that the patients are able to cooperate with macrostimulation

    Measured: 1 day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Feb 2013 (estimated)
  2. Study startFeb 2013
  3. Primary completionApr 2013
  4. Study completionApr 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
26 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01789385
Sponsor's protocol ID
DİLEKPARKİNSON
Status last verified
Feb 2013
First submitted
2 Feb 2013
Last updated
20 May 2014
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 21775052
  • 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.

    PubMed 21104443
  • 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.

    PubMed 9038464

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Dexmedetomidine in people with Parkinsons Disease, run by Diskapi Teaching and Research Hospital at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 May 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Doses of the sedative agents (time frame: 1 day). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01789385, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2014.

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