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

Parkinson's Disease Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01992692
• Other study ID #: Parkinson-remifentanil
• Status: Completed
• Phase: N/A
• First received: November 19, 2013
• Last updated: November 19, 2013
• Start date: January 2012
• Est. completion date: June 2013

Study information

• Verified date: June 2013
• Source: Changhai Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: National Natural Science Foundation
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Locations

Country	Name	City	State
China	Department of Anesthesiology, Changhai Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Changhai Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Concentrations required to inhibit response to trachea intubation and skin incision		Anesthesia induction to 5min after skin incision	No