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CTRI Number  CTRI/2017/07/009055 [Registered on: 17/07/2017] Trial Registered Retrospectively
Last Modified On: 10/07/2017
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Analytical 
Study Design  Single Arm Study 
Public Title of Study   Difference in heart rate as a predictor of low blood pressure after spinal anesthesia in diabetic patients 
Scientific Title of Study   Heart rate variability as a predictor of hypotension after spinal anaesthesia in patients with diabetes mellitus.- An analytical 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 Sukirti Baba Panta 
Designation  MD Anaesthesiology and Critical care 
Affiliation  Jawaharlal Institute of Postgraduate Medical Education and Research 
Address  blackwell 2, Jipmer Dhanvantri Nagar Puducherry
PUDUCHERRY 605006
Pondicherry
PONDICHERRY
605006
India 
Phone  9629406076  
Fax    
Email  sbp2059@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sukirti Baba Panta 
Designation  MD Anaesthesiology and Critical care 
Affiliation  Jawaharlal Institute of Postgraduate Medical Education and Research 
Address  blackwell 2, Jipmer Dhanvantri Nagar Puducherry
PUDUCHERRY 605006
Pondicherry
PONDICHERRY
605006
India 
Phone  9629406076  
Fax    
Email  sbp2059@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr V Stalin  
Designation  Associate Professor, Department of Anaesthesiology & Critical Care 
Affiliation  Jawaharlal Institute of Postgraduate Medical Education and Research 
Address  Jipmer Dhanvantri Nagar Puducherry
PUDUCHERRY 605006
Pondicherry
PONDICHERRY
605006
India 
Phone  9786397762  
Fax    
Email  drvstalin@gmail.com  
 
Source of Monetary or Material Support  
Jawaharlal Institute of Postgraduate Medical Education and Research Dhanvantri Nagar, Gorimedu, Puducherry-605 006 
 
Primary Sponsor  
Name  Jawaharlal Institute of Postgraduate Medical Education and Research 
Address  Dhanvantri Nagar, Puduherry.605006 
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 
Dr Sukirti Baba Panta  Jawaharlal Institute of Postgraduate Medical Education and Research  Department of Anesthesia and Critical Care and Department of Physiology,Dhanvantri Nagar, Gorimedu, Puducherry-605 006
Pondicherry
PONDICHERRY 
9629406076

sbp2059@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Commitee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Patients with diabetes mellitus scheduled for surgery under spinal anaesthesia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Adults with diabetes mellitus in the age-group of 20-60 years undergoing elective surgical procedures under spinal anaesthesia.
2.Height:140cm-180cm
3.Weight: 45-75kg 
 
ExclusionCriteria 
Details  1.Patient refusal for spinal anaesthesia
2.Coagulopathy
3.Pregnant patients
4.Patients with other comorbidities like hypertension, cardiac disease etc.

Patients in whom more than 1000ml of blood loss is anticipated. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
LF/HF ratio by autonomic function test  heart rate variability after 5 min of resting 5 min of standing and 5 deep breathing test 
 
Secondary Outcome  
Outcome  TimePoints 
Incidence of hypotension  Intraoperatively after spinal anaesthesia 2min, 5min, 10 min , 15min 20 min and every 10 min thereafter upto 60 min  
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
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)   10/10/2016 
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   not yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

After obtaining approval from the Institutional Ethics committee and informed consent, 120 diabetic patients undergoing elective surgeries under spinal anaesthesia will be included in this study. A thorough preoperative assessment will be done by the attending anaesthesiologist and history on duration and current treatment will be obtained. Anthropometric assessment will be done. Routine investigations like RBS, HbA1c, RFT, CXR, funds examination and ECG will be reviewed. Heart rate variability will be measured one day prior to surgery in the department of physiology. Premedication and diabetic medications will be prescribed as per the departmental protocol. 

On the day of surgery, after attaching all monitors and recording baseline parameters, preloading will be done with 15ml/kg of crystalloid solution. Spinal block will be performed in left lateral position at L3-L4 interspace and 0.5% bupivacaine 3ml will given. The level of sensory blockade will be tested with pinpricks at five-minute intervals and highest level attained will be noted. Haemodynamic parameters will be recorded throughout the intraoperative period. Any fall in blood pressure of more than 20% of the baseline will be considered as hypotension and treated with fluid bolus and Inj. Mephenteramine 6mg IV. Total vasopressor requirement will be noted. Fall in heart rate of less than 60 bpm will be considered as bradycardia and will be treated with Inj. atropine 0.6mg IV.

  1. Measuring Heart rate variability:

Cardiac Autonomic Function Test will be measured one day prior to surgery in the physiology department. Anthropometric assessment will be done. After 15 min of supine rest on a couch in the autonomic function test (AFT) lab (room temperature maintained at 25 degree C), following CAF tests will be done in the order as mentioned below: 

1) Resting Heart rate 

2) Resting Blood pressure-Systolic BP and Diastolic BP 

3) Resting short term heart rate variability (HRV): Lead II electrocardiogram (ECG) will be recorded for 5 min for Heart rate variability analysis following the standard procedure using HRV acquisition system.  

4) Lying to standing test:

5) Isometric hand grip test:

6) Deep breathing test: 


HRV analysis software will be used to analyze the frequency spectrum components using fast Fourier transformation and time domain components in the RR trend.  Standard frequency – domain measurements includes total power (T.P.), HF (0.15–0.4 Hz), LF (0.04–0.15 Hz) and LF/HF ratio and time domain parameters include mean and standard deviation of RR intervals (SDNN), mean and standard deviation of HR(SDHR), square root of the mean of the sum of the squares of differences between adjacent RR interval (RMSSD), adjacent RR interval differing more than 50 ms (NN50) and NN50 counts divided by all RR intervals (pNN50). HF, HFnu, SDNN, RMSSD, NN50 and pNN50 reflect cardiovagal tone. Other parameters will be calculated from the data as per European Task force guidelines. (13)


  1. Hemodynamic parameters:
  1. Heart rate, systolic, diastolic and Mean Arterial Pressure (NIBP) at

  • Baseline – Before preloading
  • After preloading and before spinal anaesthesia.
  • Every 2 mins for the first 10 mins.
  • Every 5 mins till the end of the surgery,

 
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