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
|
|
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
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: 4||Measurement and Monitoring, |
|
Intervention / Comparator Agent
|
|
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. |