Determination of cognitive disorders after surgery between anesthesia with isoflurane and anesthesia with complete intravenous drugs in patients undergoing spinal surgery
Design
Clinical trial, parallel group, 65 patients will be randomly selected
Settings and conduct
This trial will be conducted on patients who undergo elective spinal surgery, Shariati Hospital,Tehran,Iran.Patients are intervened in the spine surgery room of Shariati Hospital. Patients as well as the person who examines and records postoperative cognitive disorders are unaware of the type of intervention
Participants/Inclusion and exclusion criteria
Inclusion criteria include patients aged 18-65 years(ASA I-III)who undergo non-emergency spinal surgery at Shariati Hospital Exclusion criteria: use of psychiatric drugs, mental retardation, history of dementia, history Brain surgery, and dissatisfaction with participation in the study and the patient's death after surgery.
Intervention groups
The intervention group includes patients undergoing elective spinal surgery who receive complete intravenous anesthesia.
The comparison group includes patients undergoing elective spinal surgery who receive isoflurane anesthesia.
Main outcome variables
Cognitive disorders
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211023052849N3
Registration date:2022-06-08, 1401/03/18
Registration timing:retrospective
Last update:2022-06-08, 1401/03/18
Update count:0
Registration date
2022-06-08, 1401/03/18
Registrant information
Name
Arash Heroabadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8490 2373
Email address
aheroabadi@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-02-24, 1400/12/05
Expected recruitment end date
2022-06-05, 1401/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of postoperative cognitive disorders in non-emergent spinal surgery patients undergoing intravenous and isoflurane anesthesia
Public title
The effect of anesthesia types on cognitive disorders after spinal surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
≥ 18 years of age and maximum 65
Class 1 to 3 ASA anesthesia
Absence of heart failure (EF <20%)
No uncontrolled blood pressure or diabetes
No pregnancy
Willingness and satisfaction to participate in the project
Exclusion criteria:
Emergent surgery
Patient dissatisfaction with continued participation in the study
Pregnant women
History of using psychiatric medications
History of dementia
History of brain surgery
History of schizophrenia
Recent alcohol or opioid use
Severe anxiety
Mental retardation
Recent stroke
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Investigator
Sample size
Target sample size:
65
Randomization (investigator's opinion)
Randomized
Randomization description
This research uses individual randomization method. The random number sequence is generated using the "Randomization.com" website with a simple randomization method. The rest of the patients are in the group of total intravenous anesthesia (TIVA). Anesthesia is performed by an anesthesiologist and a second anesthesiologist who is not aware of the patients' randomization examines the patients for cognitive impairment.
Blinding (investigator's opinion)
Single blinded
Blinding description
The patient's physician, who is the lead researcher, induces anesthesia, and the second anesthesiologist, who has no knowledge of patient's randomization, examines patients for cognitive impairment.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tehran University of Medical Sciences
Street address
Keshavarz Blvd, Qarib street
City
Tehran
Province
Tehran
Postal code
1419733141
Approval date
2020-09-29, 1399/07/08
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1399.563
Health conditions studied
1
Description of health condition studied
Spine surgery
ICD-10 code
S24.2XXD
ICD-10 code description
Injury of nerve root of thoracic spine, subsequent encounter
Primary outcomes
1
Description
Cognitive disorders
Timepoint
Before induction of anesthesia, 6 ,12 , and 24 hours after Recovery
Method of measurement
Mini Mental State Examination questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Group 1 will be patients who are candidates for elective spinal surgery and will receive anesthesia with complete intravenous drugs by propofol induction dose(2-2.5 mg/kg IV) .After induction of anesthesia, patients received propofol as a continuous injection (using an infusion pump) at a dose of 50 to 100 μg / kg / min to maintain anesthesia. Proposol brand was BBRAUN (Germany).
Category
Treatment - Drugs
2
Description
Group 2 will be patients who are candidates for elective spinal surgery and will receive 1.5 - 3 % isoflurane anesthesia.After induction of anesthesia, isoflurane inhaled anesthetic gas with MAC 1.2 to 2% (by Drager anesthesia machine) was used to maintain anesthesia.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shariati Hospital
Full name of responsible person
Arsh Heroabadi
Street address
Tehran, North Kargar St., Jalal Al-Ahmad Intersection, Shariati Hospital
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8670 5503
Email
aheroabadi@sina.tims.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Vice Chancellor for Research and Technology, Tehran University of Medical Sciences
Street address
Poursina alley, Keshavarz Blvd, Tehran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1411713138
Phone
+98 21 8802 9256
Email
aheroabadi@sina.tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Arash Heroabadi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Shariati Hospital, Jalal-al ahmad street
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8490 1000
Email
arash.heroabadi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Arash Heroabadi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Shariati Hospital, Jalal-al ahmad street, North Kargar street
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8490 1000
Email
arash.heroabadi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Arash Heroabadi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Ali shariati Hospital, Jalal-al ahmad street
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8490 1000
Email
arash.heroabadi@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Data collected for the primary outcomes will be shared.
When the data will become available and for how long
Access starting after publication
To whom data/document is available
Clinical researchers and physicians
Under which criteria data/document could be used
Decision upon request
From where data/document is obtainable
Via email of Dr Arash Heroabadi
aheroabadi@sina.tums.ac.ir
What processes are involved for a request to access data/document