We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
ClinicalTrials.gov Menu

Anesthesia for Deep Brain Stimulation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01789385
Recruitment Status : Completed
First Posted : February 12, 2013
Last Update Posted : May 20, 2014
Information provided by (Responsible Party):
DILEK YAZICIOGLU, Diskapi Teaching and Research Hospital

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.

Condition or disease Intervention/treatment Phase
Parkinsons Disease Drug: Dexmedetomidine Phase 4

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Anesthesia for Deep Brain Stimulation for the Treatment of Parkinsons Disease
Study Start Date : February 2013
Actual Primary Completion Date : April 2013
Actual Study Completion Date : April 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Precedex 200 mcg 2ml
Drug: Dexmedetomidine
Starting with a 1 mg kg-1min-1 loading dose and than continued with a0.2-0.8 mg kg-1h-1 infusion rate.
Other Name: Precedex 200 mcg 2 ml

Primary Outcome Measures :
  1. Doses of the sedative agents [ Time Frame: 1 day ]
    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 :
  1. Time to emergence [ Time Frame: 1 day ]
    time from discontinuation of sedative drugs to time that the patients are able to cooperate with macrostimulation

Other Outcome Measures:
  1. postoperative pain scores [ Time Frame: postopertive 1 day ]
    visual analog pain scores of the patients at postoperative 1, 6, 12 and 24th hours

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   19 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01789385

Layout table for location information
Ankara Diskapi Yildirim Beyazit Teaching and Research Hospital
Ankara, Turkey
Sponsors and Collaborators
Diskapi Teaching and Research Hospital
Layout table for investigator information
Principal Investigator: Dilek YAZICIOGLU, MD Ankara Diskapi Yildirim Beyazit Teaching and Research Hospital, Turkey.
Publications of Results:
Other Publications:
Layout table for additonal information
Responsible Party: DILEK YAZICIOGLU, MD, Diskapi Teaching and Research Hospital
ClinicalTrials.gov Identifier: NCT01789385    
Other Study ID Numbers: DİLEKPARKİNSON
First Posted: February 12, 2013    Key Record Dates
Last Update Posted: May 20, 2014
Last Verified: February 2013
Keywords provided by DILEK YAZICIOGLU, Diskapi Teaching and Research Hospital:
Deep brain stimulation
Additional relevant MeSH terms:
Layout table for MeSH terms
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action