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CTRI Number  CTRI/2024/03/064855 [Registered on: 27/03/2024] Trial Registered Prospectively
Last Modified On: 25/03/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Measurement of bigger veins in the body to know variations in blood pressure after general anaesthesia  
Scientific Title of Study   Comparison of utility of pre- operative ultrasonographic measurement of internal jugular vein diameter variation versus inferior vena cava diameter variation to passive leg raising in predicting hypotension following induction of general anaesthesia: a cross sectional 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  Sahana M N  
Designation  Post graduate resident  
Affiliation  Bangalore medical college and research institute, bengaluru  
Address  Bangalore medical college and research institute bengaluru k r road fort bangalore

Bangalore
KARNATAKA
560002
India 
Phone  9740323458  
Fax    
Email  sahananatraj28@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Nethra S S  
Designation  Professor and HOD 
Affiliation  Bangalore medical college and research institute, bengaluru  
Address  Bangalore medical college and research institute bengaluru k r road fort bangalore

Bangalore
KARNATAKA
560002
India 
Phone  9448171403  
Fax    
Email  nethra.surhonne@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Swathi N 
Designation  Assistant professor  
Affiliation  Bangalore medical college and research institute, bengaluru  
Address  Bangalore medical college and research institute bengaluru k r road fort bangalore

Bangalore
KARNATAKA
560002
India 
Phone  9972454989  
Fax    
Email  swathisaggi@gmail.com  
 
Source of Monetary or Material Support  
Bangalore medical college and research institute bengaluru 
 
Primary Sponsor  
Name  Sahana M N 
Address  Bangalore medical college and research institute bengaluru k r road fort bangalore 560002 
Type of Sponsor  Other [Self] 
 
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 
Sahana M N  Hospital   Bangalore medical college and research institute bengaluru k r road fort bangalore 560002
Bangalore
KARNATAKA 		 9740323458

sahananatraj28@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Bangalore medical college and research institute  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Inferior vena cava   To compare ultrasonic measurements of internal jugular vein collapsibility index and inferior vena cava collapsibility index to predict hypotension after induction of general anaesthesia  
Intervention  Internal jugular vein  Ultrasonic measurement of internal jugular vein and inferior vena cava diameter variation to passive leg raising to predict hypotension following induction of general anaesthesia  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  Patients willing to give informed written consent
Patients belonging to ASA I,II
Patients ages between 18 to 50 years and posted elective for non- cardiac surgical procedure
 
 
ExclusionCriteria 
Details  Hemodynamically unstable patients
Patients on ACEI or ARB
Patients with unclear ultrasound images.
Patients who have been cannulated in IJV in past 6 months
Patients with mental incompetence.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1.Mean blood pressure will be measured with the patient lying in the supine position in either upper limb beginning from the base line preoperative reading till skin incision at 1-min intervals until 15 minutes after anesthetics administration.
2.Heart rate will be recorded beginning from the baseline pre-operative reading at 1-minute intervals until 15 minutes after anesthetics administration.

 		 Baseline pre- operative reading till skin incision at 1 min intervals to 15 minutes after anaesthetics administration  
 
Secondary Outcome  
Outcome  TimePoints 
1.Amount of intravenous fluid boluses & ephedrine used to manage hypotension.
2.Comparing accurateness of IVC & IJV variations in prediction of post induction hypotension.
 		 Skin incision until 15 minutes at 1 min interval after induction of general anaesthesia. 
 
Target Sample Size   Total Sample Size="330"
Sample Size from India="330" 
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)   04/04/2024 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [swathisaggi@gmail.com].

  6. For how long will this data be available start date provided 30-03-2024 and end date provided 17-03-2030?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary  

A total of 330 patients who will be scheduled for elective surgery under general anesthesia in hospitals attached to Bangalore Medical College and Research Institute, the patients fulfilling the inclusion criteria will be included for this cross sectional study after obtaining informed consent (Annexure 1).

A thorough pre -anaesthetic evaluation will be done. Tab Alprazolam 0.5 mg will be prescribed to all patients on the night prior to surgery. On arrival to the operating theatre, routine monitors in the form of pulse oximetry, electrocardiogram and non -invasive blood pressure monitors will be applied. An intravenous line will be inserted and premedication, ondansetron 4 mg and ranitidine 50mg will be administered.

 

IVC Ultrasonography

IVC evaluation will be done with patients in supine position after 5 minutes rest. Using curved probe ultrasound transducer adjusted to abdominal mode (SonoSite M-Turbo, Bothell, Washington, USA) will be placed in the subcostal area to visualize the IVC in the paramedian long -axis view. IVC will be  visualized using two-dimensional mode at the site where it enters the right atrium; then pulse wave Doppler will be used to distinguish if the viewed structure is IVC or aorta. All patients will be instructed to breathe, and through three breathing cycles, an average of three measurements will be obtained using curved probe and M-mode. Maximum IVC diameter (DIVCmax) and minimum IVC diameter (DIVCmin) will be obtained and recorded as DIVCmax1 and DIVCmin1 in the supine position. Collapsibility Index of DIVC(DIVC-CI) in the supine position will be calculated by the formula below and recorded as DIVC-CI1:

DIVC-CI1=(DIVCmax1-DIVCmin1)/DIVCmax1*100%

Patients then will be instructed to change their body positions for the PLR test, (trunk in supine position and legs elevated at 450) and the DIVCmax and DIVCmin will be measured again and recorded as DIVCmax2 and DIVCmin2, respectively. Collapsibility index calculation would be recorded as DIVC-CI2.

 

 DIVC-CI2=(DIVCmax2-DIVCmin2)/DIVCmax2*100%

   DIVC expresses the change rate of DIVC by the PLR test, and will be calculated by the following formula:

   DIVC=(DIVCmax2-DIVCmax1)/DIVCmax2*100%

IJV Ultrasonography

IJV measurements will be obtained in the supine position using a linear ultrasound transducer. Probe will be positioned horizontally at the middle level of thyroid cartilage. After obtaining a transverse clear view of the right IJV, antero- posterior diameter of IJV   will be measured using M- mode during three respiratory cycles and average of three measurements will be taken. The maximum value diameter of IJV(DIJVmax) and minimum value of diameter of IJV(DIJVmin) will be obtained as well and recorded as DIJVmax1 and DIJVmin1 in the supine position.

Collapsibility Index of DIJV(DIJV-CI) in the supine position would be calculated by the formula below and recorded as DIJV-CI1:

DIJV-CI1=(DIJVmax1-DIJVmin1)/DJVmax1*100%

Patients then will be instructed to change their body positions for the PLR test, and the DIJVmax and DIJVmin will be measured again and recorded as DIVCmax2 and DIJVmin2, respectively. Collapsibility index calculation would be recorded as DIJV-CI2.

 DIJV-CI2=(DIJVmax2-DIJVmin2)/DIJVmax2*100%

   DIJV expresses the change rate of DIJV by the PLR test , and will be calculated by the following formula:

   DIJV=(DIJVmax2-DIJVmax1)/DIJVmax2*100%

 

Induction of anesthesia  

After all data is collected, GA will be induced by injecting 2mg/kg propofol and 2mcg/kg of fentanyl, then by injecting vecuromium (0.1 mg/kg) to aid endotracheal tube insertion. Mask ventilation is commenced with the cessation of spontaneous breathing. After 3 minutes of mask ventilation, endotracheal intubation will be performed. Then volume-controlled ventilation mode will be adopted, with tidal volume of 8-10 ml/kg of ideal body weight, respiratory rate of 12-16 times/min, the fraction of inspired oxygen (FiO2) at 50% and positive end-expiratory pressure (PEEP) at 5cmH2O.Anesthesia will be maintained with isoflurane, oxygen and air. HR and MAP will be measured every 1 min after anesthesia induction for first 15 mins. Crystalloid fluid infusion will be given. The documentation of study variables will end at this point and patient management will be continued further as per institutional protocol. The one who does ultrasonography will not be involved in the further study.

Any hypotension episode, defined as MAP more than 30% below the baseline reading, will be managed by intravenous bolus of fluids and ephedrine. Any bradycardia episode (defined as heart rate less than 55bpm) will be managed by atropine (0.01mg/kg).

 

 
 
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