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Remifentanil Requirement in Patients Receiving Surgical Treatment of Parkinson's Disease

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: NCT01992692
Recruitment Status : Completed
First Posted : November 25, 2013
Last Update Posted : November 25, 2013
Sponsor:
Information provided by (Responsible Party):
Jia-feng Wang, Changhai Hospital

Tracking Information
First Submitted Date November 19, 2013
First Posted Date November 25, 2013
Last Update Posted Date November 25, 2013
Study Start Date January 2012
Actual Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 19, 2013)
Concentrations required to inhibit response to trachea intubation and skin incision [ Time Frame: Anesthesia induction to 5min after skin incision ]
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Remifentanil Requirement in Patients Receiving Surgical Treatment of Parkinson's Disease
Official Title Not Provided
Brief Summary Parkinson's disease (PD) is one the main neurodegenerative disease with an incidence of about 3% in patients older than 65 years. Anesthesia in PD patients has been focused by several studies for concerning the interactive reaction between anesthetics and anti-Parkinsonian medication or Parkinsonian symptoms. However, our previous experience showed that the patients undergoing pulse generator placement were more prone to be involved in delayed emergence in the recovery room, which had been not reported yet. We speculated that PD patients might be a special population with abnormal pharmacodynamic characters of anesthetics, though no related evidence could be found to support this hypothesis. Therefore, in this project we investigated whether remifentanl requirement to inhibit patients' response to trachea intubation and skin insertion in PD patients undergoing DBS and pulse generator placement was different from non-PD patients undergoing intracranial surgery for reasons other than PD.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Parkinsonian patients undergoing deep brain stimulator insertion and pulse generator placement, as well as non-Parkinsonian patients undergoing intracranial surgery
Condition Parkinson's Disease
Intervention Not Provided
Study Groups/Cohorts
  • PD group
    Parkinsonian patients undergoing deep brain stimulator insertion and pulse generator placement
  • non-PD group
    Non-Parkinsonian patients undergoing intracranial surgery
Publications * Wang JF, Xu XP, Yu XY, Li JB, Wu X, Chen JC, Hu XW, Deng XM. Remifentanil Requirement for Inhibiting Responses to Tracheal Intubation and Skin Incision Is Reduced in Patients With Parkinson's Disease Undergoing Deep Brain Stimulator Implantation. J Neurosurg Anesthesiol. 2016 Oct;28(4):303-8. doi: 10.1097/ANA.0000000000000229.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: November 19, 2013)
62
Original Actual Enrollment Same as current
Actual Study Completion Date June 2013
Actual Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Adult Parkinsonian patients undergoing deep brain stimulator insertion and pulse generator placement
  • Adult non-Parkinsonian patients undergoing intracranial surgery

Exclusion Criteria:

  • ASA score higher than Class II
  • predicted difficult airway
  • alcohol or drug abuser
  • informed consent was not provided
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT01992692
Other Study ID Numbers Parkinson-remifentanil
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Jia-feng Wang, Changhai Hospital
Study Sponsor Changhai Hospital
Collaborators Not Provided
Investigators Not Provided
PRS Account Changhai Hospital
Verification Date June 2013