Comparative study of Heart Rate Variability and perioperative decrease in blood pressure in pregnancy with diabetes mellitus versus normal pregnancy after spinal anaesthesia.

Not yet recruiting

• Conditions: Gestational diabetes mellitus,

• Registration Number: CTRI/2023/05/052177
• Lead Sponsor: Aishwarrya M

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 .

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2023-04-28
• Study Start: 2023-05-15

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: Female
• Target Recruitment: 50

Inclusion Criteria

• 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.

Exclusion Criteria

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.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.	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
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 Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Pradyumna Bal Memorial Hospital, Kalinga Institute of Medical Sciences; 🇮🇳 Khordha, ORISSA, India

Pradyumna Bal Memorial Hospital, Kalinga Institute of Medical Sciences

🇮🇳Khordha, ORISSA, India

Amrita Panda

Principal investigator

9439862335

amrita.panda@kims.ac.in