| CTRI Number |
CTRI/2024/01/061964 [Registered on: 29/01/2024] Trial Registered Prospectively |
| Last Modified On: |
23/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to see the influence of patient factors and anaesthesia on postoperative complications after carotid artery surgery |
|
Scientific Title of Study
|
An observational clinical study to compare the influence of patient characteristics and type of anaesthesia on neurological outcomes after carotid endarterctomy |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rana Ather |
| Designation |
Resident |
| Affiliation |
Nizams Institute of Medical Sciences |
| Address |
Department of Anaesthesiology and Intensive Care
Nizams Institute of Medical Sciences
Hyderabad
TELANGANA
500082
India |
| Phone |
8297710738 |
| Fax |
|
| Email |
ranaather9@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Abinash Patro |
| Designation |
Professor |
| Affiliation |
Nizams Institute of Medical Sciences |
| Address |
Department of Anaesthesiology and Intensive Care
Nizams Institute of Medical Sciences
Hyderabad
TELANGANA
500082
India |
| Phone |
8297710738 |
| Fax |
|
| Email |
abinash.patro@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rana Ather |
| Designation |
Resident |
| Affiliation |
Nizams Institute of Medical Sciences |
| Address |
Department of Anaesthesiology and Intensive Care
Nizams Institute of Medical Sciences
Hyderabad
TELANGANA
500082
India |
| Phone |
8297710738 |
| Fax |
|
| Email |
ranaather9@gmail.com |
|
|
Source of Monetary or Material Support
|
| Nizams Institute of Medical Sciences
Punjagutta
Hyderabad 500082 |
|
|
Primary Sponsor
|
| Name |
Nizams Institute of Medical Sciences |
| Address |
Department of Anesthesiology and Intensive Care
Punjagutta
Hyderabad |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rana Ather |
Nizams Institute of Medical Sciences |
Department of Anaesthesiology and Intensive Care
Nizams Institute of Medical Sciences
Punjagutta
Hyderabad
TELANGANA |
8297710738
ranaather9@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| NIMS Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I778||Other specified disorders of arteries and arterioles, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
All the patients with carotid artery stenosis operated for carotid endarterectomy for carotid revascularization |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To determine the in hospital neurological complications in the form of transient ischemic
attacks, major and minor strokes, cranial nerve injuries after carotid endarterectomy and
its associated risk predictors in patients operated under general and regional anaesthesia |
7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To determine the incidence of cardiovascular complications like myocardial infarction,
hemodynamically significant arrythmias and other complication like neck hematoma,
need for reoperation, prolonged hospital stay
2. To determine the total clamp time, procedure time |
7 days |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/02/2024 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
31/07/2024 |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is an observational study that will be conducted in patients who underwent carotid revascularization through carotid endarterectomy. The primary objective is to determine the in hospital neurological complications in the form of transient ischemic attacks, major and minor strokes, cranial nerve injuries after carotid endarterectomy and its associated risk predictors in patients operated under general and regional anaesthesia. The secondary outcomes are to determine the incidence of cardiovascular complications like myocardial infarction, hemodynamically significant arrythmias and other complication like neck hematoma, need for reoperation, prolonged hospital stay and to determine the total clamp time, procedure time. Patients information will be collected for demographic and clinical presentation, cardiovascular risk factors and comorbidities. Type of anaesthesia will be decided by treating anaesthesiologist. The postoperative events that will be studied are transient ischemic attacks, major and minor strokes, cranial nerve palsies.
|