To compare the functional outcomes and adverse effects when using general anesthesia versus consious sedation in patients undergoing endovascular treatment for posterior circulation stroke.
Design
The randomized controlled trial was carried out at Anesthesia Department of Combined Military Hospital Rawalpindi, PAK Emirates Military Hospital Rawalpindi
Settings and conduct
The study was conducted in Anesthesia Department of Combined Military Hospital Rawalpindi, PAK Emirates Military Hospital Rawalpindi
Participants/Inclusion and exclusion criteria
Included patients over the age of 18 years with a confirmed diagnosis of posterior circulation stroke ( PCS) by CTscan or MRA with a modified Rankin score of 2 or less than 2 at the time of stroke and considered a suitable candidate for re-canalization within 24 hours of stroke onset.
Included patients with massive intracranial hemorrhage, anterior circulation stroke, unclear radiological findings not consistent with acute posterior circulation stroke, a modified Rankin scale of more than 2 stroke onset, at pons midbrain index 3 or greater, patients with aspiration, fits, and intubation before EVT commencement and patient unwilling to be in the study or refusing follow up for the study protocol.
Intervention groups
The patients were divided into two groups, one to receive general anesthesia (GA) and other to receive conscious sedation (CS).
Main outcome variables
Functional outcome and disability in quality of life was assessed using the mRS(modified Rankin score), NIHSS(National Institute of Health Stroke Scale), GCS(Glasgow Coma Scale).
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231211060337N2
Registration date:2024-02-16, 1402/11/27
Registration timing:retrospective
Last update:2024-02-16, 1402/11/27
Update count:0
Registration date
2024-02-16, 1402/11/27
Registrant information
Name
Afzal Shabbir
Name of organization / entity
Armed Force Postgraduate Medical Institute (AFPGMI)
Country
Pakistan
Phone
+92 313 5158969
Email address
afzalshabbir68@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-08-16, 1402/05/25
Expected recruitment end date
2024-02-15, 1402/11/26
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
GENERAL ANESTHESIA VERSUS CONSIOUS SEDATION IN RECOVERY OUTCOMES OF PATIENTS UNDERGOING ENDOVASCULAR TREATMENT FOR POSTERIOR CIRCULATION STROKE
Public title
GENERAL ANESTHESIA VERSUS CONSIOUS SEDATION IN RECOVERY OUTCOMES OF PATIENTS UNDERGOING ENDOVASCULAR TREATMENT FOR POSTERIOR CIRCULATION STROKE
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Included patients over the age of 18 years with a confirmed diagnosis of posterior circulation stroke ( PCS) by CTscan or MRA with a modified Rankin score of 2 or less than 2 at the time of stroke and considered a suitable candidate for re-canalization within 24 hours of stroke onset.
Exclusion criteria:
Included patients with massive intracranial hemorrhage, anterior circulation stroke, unclear radiological findings not consistent with acute posterior circulation stroke, a modified Rankin scale of more than 2 stroke onset, at pons midbrain index 3 or greater, patients with aspiration, fits, and intubation before EVT commencement and patient unwilling to be in the study or refusing follow up for the study protocol.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
The patients were randomized into two groups of patients each, one to receive general anesthesia (GA group) and one to receive conscious sedation ( CS group). Opaque sealed envelopes were used for randomization into the designated groups by a resident anesthetist unaware of the study protocol.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical committee of combined Military Hospital
Street address
Tamizudin road lalkurti rawalpindi
City
Rawalpindi
Postal code
46000
Approval date
2023-08-01, 1402/05/10
Ethics committee reference number
CMH/RWP
Health conditions studied
1
Description of health condition studied
Posterior circulation stroke
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
To compare the functional outcomes and adverse effects when using general anesthesia versus consious sedation in patients undergoing endovascular treatment for posterior circulation stroke.
Timepoint
90 days
Method of measurement
mRS(modified Rankin score), NIHSS(National Institute of Health Stroke Scale), GCS(Glasgow Coma Scale).
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: patient in Group GA (n=60) received IV propofol 2mg/kg, IV Dexmedetomidine loading dose 1 mcg/kg over 10 minutes 15 minutes before starting the procedure with a maintenance dose of 0.5 mcg/kg/hr and IV Paracetamol 1 g state dose. IV Rocuronium was used to achieve muscle relaxation at a dose of 0.7 mg/kg
Category
Treatment - Other
2
Description
Intervention group: Patients in Group GS (n=60) received IV propofol 0.5mg/kg, IV Dexmedetomidine loading dose of 1 mcg/kg with the same maintenance dose as the GA group as well as IV Paracetamol.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Combined Military Hospital Rawalpindi
Full name of responsible person
Dr Afzal shabbir
Street address
Tamizudin road lalkurti rawalpindi
City
Rawalpindi
Postal code
46000
Phone
+92 51 9273426
Email
afzalshabbir68@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Combined Military Hospital Rawalpindi
Full name of responsible person
Dr Khalid buland
Street address
Tamizudin road lalkurti rawalpindi
City
Rawalpindi
Postal code
46000
Phone
+92 51 9273423
Email
afzalshabbir68@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Combined Military Hospital Rawalpindi
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
Combined Military Hospital Rawalpindi
Full name of responsible person
Afzal Shabbir
Position
Resident Anesthesia
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Itefaq town nai abadi kirpa road Islamabad
City
Rawalpindi
Province
Punjab
Postal code
46000
Phone
+92 313 5158969
Email
afzalshabbir68@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Combined Military Hospital Rawalpindi
Full name of responsible person
Afzal Shabbir
Position
Resident Anesthesia
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Itefaq town nai abadi kirpa road Islamabad
City
Rawalpindi
Province
Punjab
Postal code
46000
Phone
+92 313 5158969
Email
afzalshabbir68@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Combined Military Hospital Rawalpindi
Full name of responsible person
Afzal Shabbir
Position
Resident Anesthesia
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Itefaq town nai abadi kirpa road Islamabad
City
Rawalpindi
Province
Punjab
Postal code
46000
Phone
+92 313 5158969
Email
afzalshabbir68@gmail.com
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
All data could be provided
When the data will become available and for how long
Data will be available for 2 years starting from Dec 2023 till December 2025
To whom data/document is available
Academic institutions
Under which criteria data/document could be used
Interventional studies being done on the same topic
From where data/document is obtainable
afzalshabbir68@gmail.com
What processes are involved for a request to access data/document
Please contact the email provided above to ask for the data details