CTRI

FULL DETAILS (Read-only) -> Click Here to Create PDF for Current Dataset of Trial

CTRI Number

CTRI/2025/10/096107 [Registered on: 15/10/2025] Trial Registered Prospectively

Last Modified On:

14/10/2025

Post Graduate Thesis

Yes

Type of Trial

Observational

Type of Study

Cross Sectional Study

Study Design

Other

Public Title of Study

Using Neck Vein Ultrasound to Predict Blood Pressure Drops During Brain Surgery

Scientific Title of Study

Ultrasonographic evaluation of Internal Jugular Vein collapsibility index and its association with post induction hypotension in patients undergoing Supratentorial craniotomy A Prospective Observational Study

Trial Acronym

NIL

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Darson Pudhin
Designation	Junior resident
Affiliation	AIIMS RISHIKESH
Address	All India Institute of Medical Sciences, Rishikesh, Virbhadra Marg, Near Pashulok, Rishikesh Dehradun UTTARANCHAL 249203 India
Phone	7598175745
Fax
Email	darsonputhin@gmail.com

Details of Contact Person
Scientific Query

Name	Dr Sanjay Agrawal
Designation	Hod and professor
Affiliation	AIIMS RISHIKESH
Address	Department of anaesthesiology , Aiims Rishikesh , Virbhadra road , Rishikesh Dehradun UTTARANCHAL 249203 India
Phone	9761712630
Fax
Email	sanjay.anaes@aiimsrishikesh.edu.in

Details of Contact Person
Public Query

Name	Dr Sanjay Agrawal
Designation	Hod and professor
Affiliation	AIIMS RISHIKESH
Address	Department of anaesthesiology ,All India Institute of Medical Sciences, Rishikesh, Virbhadra Marg, Near Pashulok, Rishikesh Dehradun UTTARANCHAL 249203 India
Phone	9761712630
Fax
Email	sanjay.anaes@aiimsrishikesh.edu.in

Source of Monetary or Material Support

All India Institute of Medical Sciences, Rishikesh, Virbhadra Marg, Near Pashulok, Rishikesh, Uttarakhand - 249203

Primary Sponsor

Name	All India Institute of Medical Sciences
Address	All India Institute of Medical Sciences, Rishikesh, Virbhadra Marg, Near Pashulok, Rishikesh, Uttarakhand - 249203.
Type of Sponsor	Research institution and hospital

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Darson Pudhin	All India Institute of Medical Sciences	Department of anaesthesiology , Level 6 , A block All India Institute of Medical Sciences, Rishikesh, Virbhadra Marg, Near Pashulok, Rishikesh, Uttarakhand - 249203. Dehradun UTTARANCHAL	07598175745 darsonputhin@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
AIIMS RISHIKESH	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: I952\|\|Hypotension due to drugs,

Intervention / Comparator Agent

Type	Name	Details
Intervention	Nil	Nil
Intervention	Nil	Nil
Intervention	Nil	Nil
Intervention	Nil	Nil

Inclusion Criteria

Age From	18.00 Year(s)
Age To	60.00 Year(s)
Gender	Both
Details	ASA I , II, III Glasgow Coma Score more than 12

ExclusionCriteria

Details

1) Refusal to participate
2) Patients undergoing emergency craniotomies, craniotomy for vascular pathologies (Subarachnoid hemorrhage, intracranial hemorrhage, arteriovenous malformations)
3) Patients with significant hepatic, renal, cardiovascular disease,
4) Patients with morbid obesity and difficult intubation
5) Patients operated in sitting and prone position
6) Glasgow Coma score less than or equal to 12

Method of Generating Random Sequence

Not Applicable

Method of Concealment

Not Applicable

Blinding/Masking

Not Applicable

Primary Outcome

Outcome	TimePoints
To evaluate whether internal jugular vein collapsibility index can predict post induction hypotension in Patients Undergoing Supratentorial Craniotomy	collapsibity index is assessed preoperatively and compared with blood pressure measured at 10 mins

Secondary Outcome

Outcome	TimePoints
To compare the Internal Jugular Vein collapsibility index in 10-degree Trendelenburg position	Measurement taken Prior to Induction of anaesthesia
To correlate preoperative Internal Jugular Vein collapsibility index in supine & 10-degree Trendelenburg position with mean arterial pressure measured five minutes after induction	Mean arterial pressure measured at induction,1,2,3,4,5,10,15,20 minutes post induction

Target Sample Size

Total Sample Size="73"
Sample Size from India="73"
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)

10/11/2025

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 Yet Recruiting

Recruitment Status of Trial (India)

Not Yet Recruiting

Publication Details

N/A

Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?

Response - NO

Brief Summary

All the patients satisfying inclusion criteria will be evaluated at least one day prior to surgery . NPO will be explained and written informed consent will be taken . No sedative premedication will be given . On the day of surgery Iv cannulation will be performed and normal saline will be given at 10 ml/hr body weight duuring study period. Ultrasonographic measurements of IJV diameter will be taken at the level of thyroid cartilage with minimum pressure at supine and 10 degree trendelenberg position respectively . Collapsibility index will be calculated . Standard ASA monitoring and anaesthesia technique will be used in all patients. Intraarterial cannulation will be performed after applying local anaesthesia .Fentanyl 2 mcg/kg , Propofol 1.5 - 2 mg /kg . Intubation will be done with cuffed ETT of appropriate size after administration of Inj .Vecuronium 0.1 mg/kg to facilitate endotracheal intubation . Anaesthesia will be maintained in all cases using 40 percent oxygen in air , Sevoflurane . Ventilation will be controlled to maintain ETCO2 of 35 mmhg . Continuous IABP will be recorded at induction and 1,2,3,4,5,10,15,20 minutes post induction . Systolic blood pressure less than 80 or greater than 30 percent decrease from baseline will be defined as significant hypotension. Mephentermine 6 mg will be given if hypotension of SBP less than 80 mmHg occurs.