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CTRI Number  CTRI/2018/05/013696 [Registered on: 04/05/2018] Trial Registered Retrospectively
Last Modified On: 27/04/2018
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   changes in left heart relaxation after giving anaesthesia 
Scientific Title of Study   Changes in left ventricular Diastolic function under anaesthesia: A cross sectional study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Hemanth Kumar V R 
Designation  Professor 
Affiliation  Mahatma Gandhi Medical College and Research Institute 
Address  Department of anaesthesiology, second floor,B OT complex, Hospital block, Mahatma Gandhi Medical College and Research Institute, Pillayarkuppam, PONDICHERRY 607403 India

Pondicherry
PONDICHERRY
607403
India 
Phone  9003550553  
Fax    
Email  drvrhk@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  RAVISHANKAR M 
Designation  Professor 
Affiliation  Mahatma Gandhi Medical College and Research Institute 
Address  Department of anaesthesiology, second floor,B OT complex, Hospital block, Mahatma Gandhi Medical College and Research Institute, Pillayarkuppam, PONDICHERRY 607403 India
Department of anaesthesiology, second floor,B OT complex, Hospital block, Mahatma Gandhi Medical College and Research Institute, Pillayarkuppam, Pondicherry.
Pondicherry
PONDICHERRY
607403
India 
Phone  9789454016  
Fax    
Email  rshankarm@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Hemanth Kumar V R 
Designation  Professor 
Affiliation  Mahatma Gandhi Medical College and Research Institute 
Address  Department of anaesthesiology, second floor,B OT complex, Hospital block, Mahatma Gandhi Medical College and Research Institute, Pillayarkuppam, PONDICHERRY 607403 India

Pondicherry
PONDICHERRY
607403
India 
Phone  9003550553  
Fax    
Email  drvrhk@gmail.com  
 
Source of Monetary or Material Support  
Mahatma Gandhi Medical College And Research Institute, Pillayarkuppam, Pondicherry 607403 
 
Primary Sponsor  
Name  MAHATMA GANDHI MEDICAL COLLEGE AND RESEARCH INSTITUTE 
Address  Mahatma Gandhi Medical College and Research Institute Pillayarkuppam Pondicherry-607403  
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 
HEMANTH KUMAR V R  Mahatma Gandhi Medical College and Research instute   operation theater complex second floor, Mahatma Gandhi Medical college and Research Institute, Pillayarkuppam, Pondicherry 607403
Pondicherry
PONDICHERRY 
9003550553

drvrhk@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
institutional Human Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  patients posted for surgery,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NONE 
Comparator Agent  nil  none 
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Age >21 or <60yrs.
American Society of Anesthesiologist’s physical status classification 1 and 2.
Patients without left ventricular systolic dysfunction.
Patient undergoing major elective surgery lasting more than two hours. 
 
ExclusionCriteria 
Details  Poor ECHO window
BMI more than30 kg/m2
severe pulmonary disease
Patients with expected blood loss greater than allowable blood loss 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To study the changes in left ventricular diastolic function in patients
undergoing elective major surgeries under various types of anaesthesia.

To quantify changes in left ventricular diastolic function in terms of the, E
(Mitral E velocity), A (Mitral A velocity), E/A ratio, e/ (Septal/lateral e/ Mitral
annular velocity), E/e/ ratio, LA Volume index, TR (Tricuspid) velocity as
assessed by Transthoracic Echocardiography. 
TIVA- ONE MINUTE AFTER INDUCTION
INHALATION ANAESTHESIA- AFTER STEADY STATE
INTRAVENOUS PLUS INHALATIONAL- ONE MINUTE AFTE R IV AND STEADY STATE AFTER INHALATIONAL
REGIONAL WITH GA- AFTER ESTABLISHING BOTH
SPINAL- 10 MINUTES AFTER SPINAL
EPIDURAL- 20 MIN AFTER EPIDURAL
AFTER ESTABLISHING PERIPHERAL NERVE BLOCK 
 
Secondary Outcome  
Outcome  TimePoints 
none  none 
 
Target Sample Size   Total Sample Size="112"
Sample Size from India="112" 
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)   01/12/2017 
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)  Open to Recruitment 
Publication Details   NONE YET 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

After receiving approval from the institutional ethics committee, one patient

will be selected per day by simple random sampling from total number of major

surgeries posted the day. Major surgeries are defined as surgeries whose duration is

likely to exceed two hours. Written informed consent will be obtained from the

patient after sharing the information about the study.

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Pre-operative baseline trans thoracic echo (apical 4 chamber view) will be

performed in left lateral position on the selected patient using Sonosite Xporte

ultrasound machine with P21xp (1-5MHz) cardiac probe in the preoperative holding

area to record the base line Echo parameters quantifying left ventricular systolic

function (ejection fraction) and diastolic function (E, A, E/A, Septal/lateral e/, E/e/,

LA Volume index, TR velocity). If the patient has poor echo-cardiographic window

in left lateral position, ECHO will be repeated in supine position and subsequent

measurements for the patient would be taken in the same position( left lateral/

supine) where good echo cardiographic window is obtained. If the patient has left

ventricular systolic dysfunction or if the echo cardiographic window continuous to be

poor, the patient will be excluded from the study. Another patient from study

population will be selected as per the detailed procedure described above for

inclusion in the study. To maintain accuracy in measurements, all transthoracic-echo

parameters will be recorded by both the investigator and the echo-cardiographer until

the time the investigator recorded values are consistent with echo-cardiographer

values.

After recording the baseline parameters, the patient will be shifted into

operating theatre and standard monitoring will be established with SPO2, ECG,

NIBP/IBP, EtCO2, temperature and urine output measurement. The anaesthetic

technique will be as per the decision of the attending anaesthesiologist.

All the TTE measurements will be done in left lateral position/ supine position

(position in which baseline recordings are done) as per the description below.

1. If the choice is TIVA (Total intravenous anaesthesia) with propofol, the

measurement will be done one minute after induction.

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2. If the choice is inhalational anaesthesia, the measurement will be done after

obtaining steady state 1 MAC anaesthesia with Isoflurane/sevoflurane

/Desflurane.

3. If the choice is intravenous induction followed by inhalational anaesthesia,

one measurement will be done one minute after intravenous induction with

propofol and second measurement after obtaining steady state 1 MAC

anaesthesia with Isoflurane/sevoflurane /Desflurane.

4. If the choice is regional anaesthesia combined with general anaesthesia, the

measurement will be taken after establishing both.

5. If the choice is spinal, the measurement will be taken 10 minutes after spinal.

6. If the choice is epidural, the measurement will be taken 20 minutes after

epidural.

7. If the choice is peripheral nerve block, the measurement is taken after

establishing complete block.

During intermittent positive ventilation, measurement will be taken during

expiratory phase, if necessary by prolonging it, by not initiating the next breath.

During anaesthesia, the SpO2, ECG, NIBP, EtCO2 and temperature will be monitored

continuously. Care will be taken to maintain fluid balance and blood will be replaced

as per requirement. The temperature will be maintained above 36*C all the time, if

needed by active warming methods. Normocarbia will be maintained by adjusting

ventilation under general anaesthesia. Hypoxemia will be prevented by administering

O2 by mask for the patients under regional anaesthesia. Blood pressure will be

maintained within 20% of baseline by using appropriate methods. Hourly urine

output will be monitored

 
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