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A study comparing Calcium Gluconate and Phenylephrine to prevent occurrence of low blood pressure after spinal anaesthesia in women having planned caesarean section deliveries.

Comparison of Calcium Gluconate and Phenylephrine for prevention of post spinal hypotension in parturients undergoing elective caesarean section. - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/09/094870
Enrollment
70
Registered
2025-09-16
Start date
Unknown
Completion date
Unknown
Last updated
2025-10-13

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

Conditions

Health Condition 1: O82- Encounter for cesarean delivery without indication

Interventions

Intervention1: Calcium Gluconate: 10mL of 10% Inj. Calcium Gluconate with 40 mL Normal Saline infused intravenously over 15 minutes prior to induuction with spinal anaesthesia Control Intervention1: P

Sponsors

VMMC and Safdarjung Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Term parturients between 18-40 years of age belonging to American Society of Anesthesiologists (ASA) Grade II and III scheduled to undergo elective caesarean section under subarachnoid block 2. Height between 150-170 cms 3. BMI less than 30 kg/m2 4. Singleton pregnancy

Exclusion criteria

Exclusion criteria: Patients with- 1. Contraindications for regional anaesthesia like allergy to local anaesthetic drugs, local site infection or with coagulopathies 2. Inability to communicate effectively/ known psychiatric illness 3. Antepartum Haemorrhage and Pre-eclampsia/essential hypertension

Design outcomes

Primary

MeasureTime frame
To compare the incidence and severity of post-spinal hypotension between intravenous Calcium Gluconate and Phenylephrine in parturients undergoing elective caesarean section, using serial systolic blood pressure measurements. Hypotension will be defined as SBP less than 90 mm Hg or more than or equal to 20% decrease from baseline.Timepoint: Every 2 minutes for 10 minutes, then every 5 minutes until end of surgery

Secondary

MeasureTime frame
Hemodynamic Parameters which include Heart Rate (HR) Diastolic Blood Pressure (DBP) Mean Arterial Pressure (MAP) Timepoint: Every 2 minutes for 10 minutes, then every 5 minutes until end of surgery;Estimate intraoperative blood loss using gravimetric and visual method.Timepoint: ;Level of maximum Sensory blockade and Level of Motor blockade using Modified Bromage ScaleTimepoint: ;Neonatal Outcomes APGAR ScoresTimepoint: At 1 minute and 5 minutes post delivery;Umbilical Artery Blood gas analysis to assess fetal well being and effects of maternal drug intervention on the neonateTimepoint: ;Maternal Serum Calcium Levels Timepoint: Preoperative (baseline) Postoperative (at skin closure)

Countries

India

Contacts

Public ContactDr Radhika Thakur

VMMC and Safdarjung hospital

drsainisumannony@gmail.com9891228793

Outcome results

None listed

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