Requirement of Propofol for Induction of Unconsciousness in Patients With Parkinson's Disease

Parkinson's Disease Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01998204
• Other study ID #: Parkinson-propofol
• Status: Completed
• Phase: N/A
• First received: November 19, 2013
• Last updated: November 23, 2013
• Start date: January 2012
• Est. completion date: June 2013

Study information

• Verified date: November 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 the second most prevalent neurodegenerative disease. The investigators clinical experience showed a trend of delayed emergence among patients undergoing deep brain stimulator (DBS) implantation and pulse generator placement under general anesthesia. Abnormal pharmacodynamics might be present among these patients, which had never been investigated.

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:

• Patients with Parkinson's disease undergoing deep brain stimulator implantation and pulse generator placement under general anesthesia

• non-Parkinsonian patients without Parkinson's disease undergoing intracranial surgery under general anesthesia

Exclusion Criteria:

• ASA score higher than Class III

• predicted difficult airway

• hearing impairment

• inability to corporate with instruction

• alcohol or drug abuser

• patients refusing to provide informed consent

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	Consciousness status	Consciousness status is evaluated by the observer's assessment of alertness and sedation score (OAA/S).	Participants will be monitored during the period of propofol infusion, an expected average of less than 10 min	No