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

Heart rate variability and perioperative hypotension in gestational diabetes versus healthy parturients after subarachnoid block.

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2023/05/052177
Enrollment
50
Registered
2023-05-01
Start date
Unknown
Completion date
Unknown
Last updated
2023-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O244- Gestational diabetes mellitus

Interventions

Control Intervention1: NIL: NIL

Sponsors

Aishwarrya M
Lead Sponsor

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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. Timepoint: 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

MeasureTime frame
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 scaleTimepoint: 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.

Countries

India

Contacts

Public ContactAmrita Panda

Kalinga Institute of Medical Sciences

amrita.panda@kims.ac.in9439862335

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026