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Anesthesia for Deep Brain Stimulation

Primary Purpose

Parkinsons Disease

Status
Completed
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Dexmedetomidine
Sponsored by
Diskapi Teaching and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinsons Disease focused on measuring Deep brain stimulation, Parkinson

Eligibility Criteria

19 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients undergoing DBS for the treatment of PD

Exclusion Criteria:

  • 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.

Sites / Locations

  • Ankara Diskapi Yildirim Beyazit Teaching and Research Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

dexmedetomidine

Arm Description

Precedex 200 mcg 2ml

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
February 2, 2013
Last Updated
May 19, 2014
Sponsor
Diskapi Teaching and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01789385
Brief Title
Anesthesia for Deep Brain Stimulation
Official Title
Anesthesia for Deep Brain Stimulation for the Treatment of Parkinsons Disease
Study Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
April 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Diskapi Teaching and Research Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinsons Disease
Keywords
Deep brain stimulation, Parkinson

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
dexmedetomidine
Arm Type
Other
Arm Description
Precedex 200 mcg 2ml
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Other Intervention Name(s)
Precedex 200 mcg 2 ml
Intervention Description
Starting with a 1 mg kg-1min-1 loading dose and than continued with a0.2-0.8 mg kg-1h-1 infusion rate.
Primary Outcome Measure Information:
Title
Doses of the sedative agents
Description
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
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Time to emergence
Description
time from discontinuation of sedative drugs to time that the patients are able to cooperate with macrostimulation
Time Frame
1 day
Other Pre-specified Outcome Measures:
Title
postoperative pain scores
Description
visual analog pain scores of the patients at postoperative 1, 6, 12 and 24th hours
Time Frame
postopertive 1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients undergoing DBS for the treatment of PD Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dilek YAZICIOGLU, MD
Organizational Affiliation
Ankara Diskapi Yildirim Beyazit Teaching and Research Hospital, Turkey.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ankara Diskapi Yildirim Beyazit Teaching and Research Hospital
City
Ankara
Country
Turkey

12. IPD Sharing Statement

Citations:
PubMed Identifier
21775052
Citation
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.
Results Reference
background
PubMed Identifier
21104443
Citation
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.
Results Reference
background
PubMed Identifier
9038464
Citation
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.
Results Reference
result

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Anesthesia for Deep Brain Stimulation

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