| CTRI Number |
CTRI/2025/11/097870 [Registered on: 21/11/2025] Trial Registered Prospectively |
| Last Modified On: |
19/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
can Common Carotid Artery corrected flow time (FTc) be used to tell in advance weather neurosurgery patients will have hypotension after induction of anaesthesia . |
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Scientific Title of Study
|
Evaluation of role of Common Carotid Artery corrected flow time (FTc) in predicting post-induction hypotension in patients undergoing elective craniotomy under general anaesthesia. |
| Trial Acronym |
NIL |
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Jagan Kua |
| Designation |
Junior Resident |
| Affiliation |
AIIMS RAIPUR |
| Address |
B block OT Complex, 4th floor, Department of Anaesthesiology, AIIMS, G.E Road, Tatibandh, Raipur, Chhattisgarh, 492099
Raipur CHHATTISGARH 492099 India |
| Phone |
9692265503 |
| Fax |
|
| Email |
jagankuambbs99@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Nupur Karan |
| Designation |
Associate Professor |
| Affiliation |
AIIMS, Raipur |
| Address |
B block OT Complex, 4th floor, Department of Anaesthesiology, AIIMS, G.E Road, Tatibandh, Raipur, Chhattisgarh, 492099
Raipur CHHATTISGARH 492099 India |
| Phone |
9867897031 |
| Fax |
|
| Email |
nupurkaran2989@yahoo.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Nupur Karan |
| Designation |
Associate Professor |
| Affiliation |
AIIMS, Raipur |
| Address |
B block OT Complex, 4th floor, Department of Anaesthesiology, AIIMS, G.E Road, Tatibandh, Raipur, Chhattisgarh, 492099
Raipur CHHATTISGARH 492099 India |
| Phone |
9867897031 |
| Fax |
|
| Email |
nupurkaran2989@yahoo.com |
|
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Source of Monetary or Material Support
|
| All india institute of medical sciences, Raipur |
|
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Primary Sponsor
|
| Name |
All india institute of medical sciences Raipur |
| Address |
All india institute of medical sciences, Great Eastern road, tatibandh, Raipur, 492099 |
| Type of Sponsor |
Research institution and hospital |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
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Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Jagan Kua |
AIIMS RAIPUR |
B block OT Complex, 4th floor, AIIMS Raipur, Tatibandh, Chhattisgarh, 492099, Raipur Raipur CHHATTISGARH |
9692265503
jagankuambbs99@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee |
Approved |
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C700||Malignant neoplasm of cerebral meninges, (2) ICD-10 Condition: C710||Malignant neoplasm of cerebrum, except lobes and ventricles, (3) ICD-10 Condition: C711||Malignant neoplasm of frontal lobe, (4) ICD-10 Condition: C712||Malignant neoplasm of temporal lobe, (5) ICD-10 Condition: C713||Malignant neoplasm of parietal lobe, (6) ICD-10 Condition: C714||Malignant neoplasm of occipital lobe, (7) ICD-10 Condition: C715||Malignant neoplasm of cerebral ventricle, (8) ICD-10 Condition: C716||Malignant neoplasm of cerebellum, (9) ICD-10 Condition: C717||Malignant neoplasm of brain stem, (10) ICD-10 Condition: C718||Malignant neoplasm of overlappingsites of brain, (11) ICD-10 Condition: C719||Malignant neoplasm of brain, unspecified, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Common Carotid Artery Corrected Flow Time (FTc) |
Side: Right side common carotid artery
Position: Supine position with neck slightly tilted to left |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
American Society of Anaesthesiologists (ASA) physical status 1 or 2
Scheduled for elective neuro-surgery under general anaesthesia.
|
|
| ExclusionCriteria |
| Details |
1. Emergency Surgery
2. Poor ultrasonographic window for measurements
3. Cardiac arrhythmias at the time of measurements
4. Carotid artery stenosis greater than 50 percent or occluded carotid arteries
5. Baseline systolic blood pressure less than 90mmHg or mean arterial pressure less than 65mm Hg
6. Patient is on mechanical ventilation prior to induction
7. Prior use of angiotensin-converting enzyme Inhibitors or angiotensin receptor blockers
8. History of any previous neck surgery or trauma
9. Pregnancy
10.History of peripheral arterial diseases or atherosclerosis
|
|
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Method of Generating Random Sequence
|
Not Applicable |
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Method of Concealment
|
Not Applicable |
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Blinding/Masking
|
Not Applicable |
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Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the role of Common Carotid artery FTc for detecting post-induction hypotension in patients undergoing neurosurgery under general anaesthesia. |
Within 15 minutes post induction |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
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Target Sample Size
|
Total Sample Size="100" Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/01/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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Brief Summary
|
Hypotension is a common complication when general anaesthesia (GA) is initiated. This drop in blood pressure can be triggered by various factors, notably low blood volume, advanced age, significant systemic disease (ASA III or higher), anaesthetic agents, compromised physiological responses, and impaired cardiac function. While intraoperative hypotension is known to worsen outcomes in both cardiac and non-cardiac surgeries, it carries particular significance in neurosurgical procedures. Even brief periods of post-induction hypotension, which may be tolerated in general surgery, can be harmful in neurosurgery and significantly affect patient recovery. Whether a patient’s brain can properly regulate blood flow or not, hypotension can have detrimental neurological consequences. In patients with intact autoregulation, it can paradoxically increase intracranial pressure (ICP) due to reflex vasodilation and increased cerebral blood volume. In contrast, for those with impaired autoregulation, hypotension can lead to cerebral ischemia. Neurosurgical patients are particularly vulnerable to developing low blood volume due to factors such as poor oral intake related to reduced consciousness or cranial nerve deficits, vomiting caused by elevated ICP, the effects of medications like mannitol used to reduce brain swelling, and complications from conditions like diabetes insipidus (DI). Low blood volume can lead to hypotension during administration of anaesthesia. Anaesthesiologists play a vital role in managing intraoperative hypotension by early detection and management of hypotension. The relationship between a neurosurgical patient’s preoperative fluid status and the degree of hypotension following anaesthesia induction is still unclear. Historically, the diagnosis of low blood volume depended on clinical assessments (e.g., tachycardia, weak pulse) and laboratory tests (e.g., haematocrit levels), which have limitations and invasive approaches like central venous pressure and pulse pressure variation. More recently ultrasonography (USG) has been used for visualisation of major vessels and obtaining various parameters or indices for determination of fluid status of the patients. Many parameters have emerged by analysing the flow, diameter of great vessels like IVC collapsibility index (IVCCI), caval/aorta diameter index, and corrected flow time (FTc, derived from carotid artery). Goyal et al evaluated the relationship between IVCCI and post-induction reduction in mean arterial blood pressure, and reported a good association with each other with an area under receiver operator curve (AUC) of 0.65 and an optimal cutoff for IVCCI of 37.5%. Fathy et al explored the role of caval /aorta diameter index and IVCCI with post general anaesthesia induction hypotension and found an AUC of 0.95 and 0.93 respectively. Doppler-derived hemodynamic parameters, like Common Carotid Artery corrected flow time (FTc) have emerged as indicators of volume responsiveness in diverse clinical settings. The Common Carotid Artery corrected flow time (FTc), defined as the heart rate-normalized interval from systolic flow onset to aortic valve closure, reflects intravascular volume status. Carotid Artery Doppler ultrasonography offers the advantages of being non-invasive and technically facile due to the superficial location of the vessel. Critically, FTc is not influenced by respiratory mechanics, extending its applicability to spontaneously breathing patients. Kim et al. demonstrated the predictive power of both FTc for fluid responsiveness, however their study did not explore their ability to anticipate post-induction hypotension. As prediction of postinduction of hypotension is important, we designed a prospective observational study to determine the utility of the common carotid artery corrected flow time (FTc) for prediction of hypotension after induction of general anaesthesia in patients undergoing elective craniotomy surgeries. Any hypotension that occurred in up to 15 minutes of induction of general anaesthesia will be evaluated in this study. We are going to do this study because there are very limited studies in evaluating role of FTc in patients undergoing neurosurgeries. After taking written informed consent from the participants, the FTc will be measured in right common carotid artery in supine position by a 6 to 13 MHz linear probe in the preop area 3 times and the mean will be used are main data. after that patient will be taken into operation room and after induction of general anaesthesia, in every 3 minute desired parameters will be recorded till 15 minutes post induction. If systolic blood pressure fall is less than 90 mmHg or less than 30 percent from baseline or mean arterial pressure less than 65mmHg or fall in mean arterial pressure is more than 20 percent from baseline than we will call it as post induction hypotension. |