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A study on the effect of crystalloid versus colloid infusion after spinal anaesthesia for elective cesarean section on maternal blood pressure and fetal well being.

A Prospective Randomised Double-Blinded Comparison of Crystalloid versus Colloid Coload with Phenylephrine Infusion During Spinal Anaesthesia for Elective Caesarean Delivery: The Effects on Maternal Haemodynamics and Foetal Acid-Base Status

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2012/06/002754
Enrollment
60
Registered
2012-06-28
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: null- Elective Caesarean Section under spinal anaesthesia

Interventions

Intervention1: Spinal anaesthesia, Phenylephrine infusion: An intrathecal dose of hyperbaric bupivacaine 0.5%, 2ml (10 mg) with fentanyl 15 µg will be injected over 30 seconds The phenylephrine infu

Sponsors

Department of Anaesthesiology All India Institute of Medical Sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 60 ASA physical status I and II parturients with singleton pregnancies scheduled for elective caesarean delivery under spinal anaesthesia will be recruited in this study.

Exclusion criteria

Exclusion criteria: 1. Women with pre-existing or pregnancy induced hypertension (SBP >140 mmHg or diastolic BP >90 mmHg). 2. Known cardiovascular or cerebro-vascular disease. 3. Foetal abnormality. 4. Contraindication to spinal anaesthesia. 5. Height 180 cm. 6. Pre-pregnancy BMI >32kg/m2. 7. Patients with signs of onset of labour. 8. Multiple pregnancy

Design outcomes

Primary

MeasureTime frame
Incidence of maternal hypotensionTimepoint: Every one minute from institution of spinal anaesthesia to the uterine incision—

Secondary

MeasureTime frame
a.Incidence of reactive hypertension b.Incidence of bradycardia c.Incidence of nausea and vomiting d.Umbilical artery and umbilical vein gas analysis (pH, pCO2, pO2, base excess) e.Neonatal Apgar score at 1 and 5 minutes Timepoint: After institution of spinal anaesthesia till the uterins incision—

Countries

India

Contacts

Public ContactDeepak Singhal

All India Institute of Medical Sciences

singhal_deepak@hotmail.com09873667459

Outcome results

None listed

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