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CTRI Number  CTRI/2019/06/019733 [Registered on: 18/06/2019] Trial Registered Prospectively
Last Modified On: 12/06/2019
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   case series 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   Measuremnt of width of major blood vessel through a scan to predict decrease in blood pressure due to a drug 
Scientific Title of Study   Ultrasonographic measurement of Inferior Vena Cava collapsibility index in predicting Propofol Induced Hypotension in general anaesthesia: A case series study.  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr S Y Hulakund 
Designation  Professor of Anaesthesiology and Head of the department 
Affiliation  S N Medical College 
Address  Department of Anaesthesia S N Medical College Navanagar Bagalkot

Bagalkot
KARNATAKA
587102
India 
Phone  9901098533  
Fax    
Email  hulkunds@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr S Y Hulakund 
Designation  Professor of Anaesthesiology and Head of the department 
Affiliation  S N Medical College 
Address  Department of Anaesthesia S N Medical College Navanagar Bagalkot

Bagalkot
KARNATAKA
587102
India 
Phone  9901098533  
Fax    
Email  hulkunds@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr S Y Hulakund 
Designation  Professor of Anaesthesiology and Head of the department 
Affiliation  S N Medical College 
Address  Department of Anaesthesia S N Medical College Navanagar Bagalkot

Bagalkot
KARNATAKA
587102
India 
Phone  9901098533  
Fax    
Email  hulkunds@yahoo.com  
 
Source of Monetary or Material Support  
S N Medical College and HSK Hospital Navanagar Bagalkot 587102 
 
Primary Sponsor  
Name  S N Medical College and HSK hospital 
Address  Navanagar Bagalkot 587102 
Type of Sponsor  Private medical college 
 
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 
Dr Manjunath B  S Nijalingappa Medical College and HSK Hospital  Department of Anaesthesia S N Mediacl College and HSK hospital navanagar Bagalkot
Bagalkot
KARNATAKA 
9480013943

manjunath0993@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SNMC-Institutional Ethics committee on human subjects research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: 4||Measurement and Monitoring,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients aged between 18 to 60 yrs.
ASA (American society of anesthesiologist) grade I and II.
Patients posted for surgery under general anaesthesia.

 
 
ExclusionCriteria 
Details  Patients with major peripheral vascular disease
2. Unstable angina or ejection fraction less than 40%
3. Respiratory distress
4. Increased intraabdominal pressure
5. Autonomic nervous system disorders
6. Anticipated difficult airway
7. Mental incompetence
8. Patients who have currently taken angiotensin-converting enzyme inhibitor or angiotensin receptor blocker will be excluded.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To investigate whether preoperative ultrasound IVC measurements could predict hypotension after induction of anesthesia by ultrasound measurements of IVC collapsibility index  10 minutes after induction 
 
Secondary Outcome  
Outcome  TimePoints 
Hypotension associated complication  10 minutes after induction 
 
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)   01/07/2020 
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   According to study conducted by 11Zhang J,Critchley L A H,104 patients undergoing surgery under general anaesthesia,aged 18-60 years ASA 1-3 ,it was found that collapsibility index was an independent predictor of hypotension with odds ratio of 1.17 and concluded that preoperative ultrasound IVC,CI measurement also reliable predictor of hypotension after induction of general anaesthesia. 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Hypotension is common during surgery in patients under anesthesia and may cause organ underperfusion and ischemia. After induction of general anesthesia, patients are at particular risk of developing hypotension because of the cardiovascular depressant and vasodilatory effects of anesthetic agents, as well as lack of surgical stimulation. Furthermore, patients may have preexisting hypovolemia resulting from dehydration and impaired compensatory responses, which increase the risk. Severe episodes of intraoperative hypotension have been proposed as an independent risk factor in the development of postoperative adverse outcomes such as myocardial infarction, stroke, heart failure, acute kidney injury, prolonged hospital stay, and even increased 1-yr mortality rates both in patients undergoing cardiac surgery and in those undergoing noncardiac surgery. Predictors of hypotension after induction of anesthesia include American Society of Anesthesiologists physical status (ASA) III and IV, baseline mean arterial pressure lower than 70 mmHg, age more than 60yr, use of high fentanyl dose. Heart rate (HR) variability can predict hypotension and bradycardia after induction of anesthesia. However, the role of preoperative volume status in the development of hypotension after induction will not been assessed fully. A surgical patient’s preoperative volume status may vary due to physical status, comorbidities, and preoperative treatments such as bowel preparation and fasting, and these contributory factors have been shown to have an influence on the patient’s susceptibility to intraoperative hypotension. Assessing intravascular volume status is a challenge for clinicians. Traditional static parameters such as central venous pressure have been criticized for invasiveness and lack of accuracy. A number of dynamic parameters that assess volume status have been recommended recently. Ultrasound measurements of inferior vena cava (IVC) diameter with respiration, which include (1) maximum diameter of the IVC (dIVCmax) at the end of expiration during spontaneous respiration and (2) collapsibility index (CI), have been recommended as rapid and noninvasive methods for estimating volume status. These parameters have been proposed as repeatable and easily obtainable parameters by operators with little experience in echocardiography. Ultrasound measurement of the IVC has been studied extensively as a predictor of fluid responsiveness in different clinical settings, and several studies have demonstrated that dIVCmax and CI are reliable indicators of intravascular volume status. Therefore, we hypothesized that preoperative dIVCmax and its respiratory variation, that is, CI, could predict the incidence of hypotension after induction of general anesthesia.

 
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