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CTRI Number  CTRI/2023/05/052177 [Registered on: 01/05/2023] Trial Registered Prospectively
Last Modified On: 28/04/2023
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Case Control Study 
Study Design  Other 
Public Title of Study   Comparative study of Heart Rate Variability and perioperative decrease in blood pressure in pregnancy with diabetes mellitus versus normal pregnancy after spinal anaesthesia. 
Scientific Title of Study   Heart rate variability and perioperative hypotension in gestational diabetes versus healthy parturients after subarachnoid block. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Aishwarrya M 
Designation  Post Graduate Trainee 
Affiliation  Kalinga Institute of Medical Sciences  
Address  Department of Anaesthesia Kalinga Institute of Medical Sciences Bhubaneswar
Deparment of Anaesthesia Kalinga Institute of Medical Sciences Bhubaneswar 751024
Khordha
ORISSA
751024
India 
Phone  9000940077  
Fax    
Email  aishwarryamuruganv@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Amrita Panda  
Designation  Professor 
Affiliation  Kalinga Institute of Medical Sciences 
Address  Department of Anaesthesia Kalinga Institute of Medical Sciences Bhubaneswar 751024

Khordha
ORISSA
751024
India 
Phone  9439862335  
Fax    
Email  amrita.panda@kims.ac.in  
 
Details of Contact Person
Public Query  
Name  Amrita Panda  
Designation  Professor 
Affiliation  Kalinga Institute of Medical Sciences 
Address  Department of Anaesthesia Kalinga Institute of Medical Sciences Bhubaneswar 751024

Khordha
ORISSA
751024
India 
Phone  9439862335  
Fax    
Email  amrita.panda@kims.ac.in  
 
Source of Monetary or Material Support  
Kalinga Institute of Medical Sciences, Bhubaneswar 
 
Primary Sponsor  
Name  Aishwarrya M 
Address  3F-56, Queens Castle 10 Campus 5 KIIT University Patia Bhubaneswar 751024 
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 
Amrita Panda  Pradyumna Bal Memorial Hospital, Kalinga Institute of Medical Sciences  Department of Anaesthesia Kalinga Institute of Medical Sciences Bhubaneswar 751024
Khordha
ORISSA 		 9439862335

amrita.panda@kims.ac.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O244||Gestational diabetes mellitus,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  1) All willing participants giving written informed consent will be included.
2) Age 18 to 40 years
3) American society of Anaesthesiologist (ASA) Physical Status II posted for scheduled lower segment caesarean section
4) American society of Anaesthesiologist (ASA) Physical Status II with diagnosis of gestational diabetes mellitus (defined as any degree of glucose intolerance with an onset, or first recognition during pregnancy6 posted for scheduled lower segment caesarean section
5) Pregnant females with BMI less than or equal to 30Kg/m2

 
 
ExclusionCriteria 
Details  1) Patient refusal for spinal anaesthesia
2) Contraindications of subarachnoid block
3) Emergency LSCS
4) Patients posted for LSCS under general anaesthesia
5) Any CVS/Hepatic/Renal impairment (pregnancy induced hypertension, heart disease)
6) Allergies to local anaesthesia
7) Disorders affecting autonomic nervous system
8) Twin pregnancy
 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
1. To measure the changes in hemodynamic parameters [systolic blood pressure, diastolic blood pressure(mmHg), mean arterial pressure(mmHg), heart rate(beats/min)] after subarachnoid block in parturients with gestational diabetes versus healthy parturients.
2. Use of baseline heart rate variability parameters (LF, HF, LF/HF) to predict these changes between the two groups.
 		 1) Heart rate variability parameters of frequency domain (LF, HF, LF/HF) at baseline (24 hours prior to the procedure)
2) Hemodynamic parameters (Systolic blood pressure, Diastolic blood pressure, mean arterial pressure, heart rate) at baseline, at 5 minutes after subarachnoid block, every 10 minutes for first 30 minutes, at ever 30 minutes,at 2hours, 6 hours and 12 hours
 
 
Secondary Outcome  
Outcome  TimePoints 
1)To compare the use of intravenous fluid(ml) and vasopressors(mg) after subarachnoid block in both groups.
2) To compare side effects like postoperative nausea vomiting in both groups using severity scale 		 1) Use of IV fluids crystalloid (ringer lactate, normal saline in millilitres) in first 30mins, till end of surgery and up to 12 hours
Use of vasopressors for first 30 mins, till end of surgery and up to 12 hours.
2) Nausea and vomiting up to 12 hours. 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   15/05/2023 
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="1"
Days="2" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details    
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
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [amrita.panda@kims.ac.in].

  6. For how long will this data be available start date provided 25-05-2025 and end date provided 21-06-2028?
    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   Regional anaesthesia primarily subarachnoid block is the preferred method of anaesthesia for elective caesarean section as it encompasses less risk to mother and fetus as compared to general anaesthesia. Hypotension after spinal anaesthesia is the most common side effect due to sympatholysis. Subarachnoid block causes sympatholysis which leads to vasodilatation. This in turn leads to maternal hypotension, decrease in uterine blood flow and fetal circulation, thus leading to fetal hypoxia, bradycardia and acidosis.  
Systemic hemodynamic regulation is maintained by the autonomic nervous system and the sympathetic activity is known to be increased during pregnancy. Sympatholysis therefore leads to higher degree of peripheral vasodilatation and a predominant parasympathetic activity consequently reducing the venous return and cardiac preload, resulting in bradycardia, nausea, and vomiting. Studies have shown that heart rate variability parameters can predict hypotension of subarachnoid block in parturients.
Heart rate variability is standard variation in time sequence (R-R intervals). The time domain analysis reports activity of circulatory system. The frequency domain analysis reflects the sympathovagal balance of autonomic nervous system.The frequency domain measures have spectral components. Very low frequency (0.0033-0.04Hz), low frequency(0.04-0.15Hz) and high frequency (0.15-0.4Hz), very low frequency components is less defined, low frequency reflects a combination of sympathetic, parasympathetic and autonomic nervous system outflow variations, high frequency reflects vagal mediation of cardiac activity.  Low frequency /high frequency ratio is used as an index for assessing sympathovagal balance.  
Heart rate variability exists among women with gestational diabetes. Gestational diabetes is defined as any degree of glucose intolerance with an onset, or first recognition during pregnancy. Inadequate evidence exists on the use of preoperative heart rate variability parameters to compare hemodynamic changes after subarachnoid block in parturients with gestational diabetes mellitus versus healthy parturients, so we designed this prospective observational study .
 
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