The effect of sevoflurane versus propofol on the quality of neurologic recording, recovery time and hemodynamic profile in deep brain stimulation for Parkinson surgery
To compare the effects of Propofol and Sevoflurane on the quality of the neurological examination, hemodynamic profile and duration of recovery from anesthetics in DBS surgery for Parkinson's disease
Design
Randomized double-blind clinical trial
Settings and conduct
Patients were randomly allocated into two groups of propofol and sevoflurane. The patients, assessor and the analyzer were blinded to the assignments.
The setting was Rasoul Akram University hospital
Participants/Inclusion and exclusion criteria
Patients with severe Parkinson undergoing DBS Surgery
Intervention groups
Propofol
Sevoflurane
Main outcome variables
Time to wake up the patient after discontinuing anesthetics
Firing Rate
Peak To Peak
General information
Reason for update
Acronym
Deep Brain Stimulation-DBS
IRCT registration information
IRCT registration number:IRCT20101026005026N8
Registration date:2018-05-07, 1397/02/17
Registration timing:registered_while_recruiting
Last update:2018-05-07, 1397/02/17
Update count:0
Registration date
2018-05-07, 1397/02/17
Registrant information
Name
Masood Mohseni
Name of organization / entity
Rasul Akram hospital, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6435 2326
Email address
mohseni@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research - Iran University of Medical Sciences
Expected recruitment start date
2017-05-01, 1396/02/11
Expected recruitment end date
2018-05-20, 1397/02/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of sevoflurane versus propofol on the quality of neurologic recording, recovery time and hemodynamic profile in deep brain stimulation for Parkinson surgery
Public title
The effect of anesthetics in DBS surgery in Parkinson patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with Advanced Parkinson's
Patients with severe dyskinesia due to levodopa administration
Exclusion criteria:
Severe cardiovascular or ischemic diseases
Uncontrolled hypertension
CVA
Cancer or any life-threatening agent
Taking anti-coagulants
Severe psychiatric disorders
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Patients were randomly allocated to the propofol/sevoflurane groups. Simple Randomization was performed using a table of random numbers.
Blinding (investigator's opinion)
Double blinded
Blinding description
The patients, outcome assessor and data analyser were blinded to the assignments
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Hemmat Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
۱۴۴۵۶۱۳۱۳۱
Approval date
2017-04-12, 1396/01/23
Ethics committee reference number
IR.IUMS.RES.1395.9211174005
Health conditions studied
1
Description of health condition studied
Parkinson disease
ICD-10 code
G20
ICD-10 code description
Hemiparkinsonism Paralysis agitans Parkinsonism or Parkinson disease: NOS idiopathic primary
Primary outcomes
1
Description
Duration of recovery from anesthetics
Timepoint
During the targeting of subthalamic nucleus
Method of measurement
Minutes using a chronometer
2
Description
Blood pressure
Timepoint
Every 5 minutes during the maintenance of anesthesia
Method of measurement
Automatic noninvasive sphyngometer
Secondary outcomes
1
Description
Heart rate
Timepoint
Before induction, half an hour after induction, before discontinuation of anesthetics, during neurological examination every 15 minutes, at the end of surgery
Method of measurement
Continuous ECG monitoring
Intervention groups
1
Description
Propofol 30 microgram/kg for maintenace of anesthesia
Category
Treatment - Drugs
2
Description
Sevoflourane 1% for maintenance of anesthesia
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Rasoul Akram hospital
Full name of responsible person
Masood Mohseni
Street address
Rasool Akram hospital, Niayesh Ave, Sattarkhan St
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6435 2326
Email
masood.mohseni@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Ali Javad Mousavi
Street address
Iran University Of Medical Science, Hemat Highway
City
Tehran
Province
Tehran
Postal code
۱۴۴۵۶۱۳۱۳۱
Phone
+98 21 8670 5503
Email
mohseni@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Masood mohseni
Position
Associate professor
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Rasoul Akram hospital, Niayesh Ave, Sattarkhan St.
City
Tehran
Province
Tehran
Postal code
۱۴۴۵۶۱۳۱۳۱
Phone
+98 21 6435 2326
Fax
Email
Mohseni@med.mui.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Masood Mohseni
Position
Associate Professor
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Rasoul Akram Hospital, Niayesh Ave, SattarKhan St.
City
Tehran
Province
Tehran
Postal code
۱۴۴۵۶۱۳۱۳۱
Phone
+98 21 6435 2326
Fax
Email
masood.mohseni@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Maryam Khodaverdi
Position
Resident of Anesthesiology
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Rasoul Akram hospital, Niayesh Ave, Sattarkhan St.
City
Tehran
Province
Tehran
Postal code
۱۴۴۵۶۱۳۱۳۱
Phone
+98 21 6435 2326
Fax
Email
maryamkhodaverdi@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Data regarding primary and secondary outcomes will be available
When the data will become available and for how long
immediately after publication
To whom data/document is available
only faculty members and academic institutions
Under which criteria data/document could be used
The result of further analysis may not be presented to public without permission
From where data/document is obtainable
masood.mohseni@gmail.com
What processes are involved for a request to access data/document
A reasonable request from an academic source will be responded within 10 working days