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USE OF DEXAMETHASONE FOR PREVENTION OF HYPOTENSION AFTER SPINAL ANAESTHESIA IN PREGNANT FEMALE UNDERGOING CAESAREAN SECTION

Effect of Dexamethasone for prevention of post-spinal hypotension in parturients undergoing caesarean section: A double blind randomised controlled trial

Status
Active, not recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/09/045754
Enrollment
170
Registered
2022-09-21
Start date
Unknown
Completion date
Unknown
Last updated
2024-07-22

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

Conditions

Health Condition 1: 1- Obstetrics

Interventions

Intervention1: intravenous (i.v.) dexamethasone: 8 mg(2ml) diluted in 10 mL of normal saline ,single shot over 10 min Control Intervention1: normal saline: 10 mL ,iv , single shot over 10 min

Sponsors

AIIMS JODHPUR
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Adult (age >18 years) female with a singleton pregnancy and a gestational age ?37 weeks, of ASA grade I or II, planned for an elective caesarean section under spinal anaesthesia

Exclusion criteria

Exclusion criteria: 1. Refusal of informed consent 2. Hemodynamic instability 3. Patients having known allergic reaction to study drug 4. Patients with hypertensive disorders of pregnancy, gestational diabetes or cardiovascular insufficiency 5. Patients with height 40 kg/m2 6. Patient with underlying medical condition with long term use of steroids 7. Patients with contraindication to SA (coagulopathy, thrombocytopenia, allergy to local anaesthetic agent)

Design outcomes

Primary

MeasureTime frame
To compare incidence of post spinal hypotension (decrease in SBP 20% of baseline) from spinal block to deliveryTimepoint: Post spinal Intraoperatively 1min, 2min, 3min, 4 min, 5 min, 6 min, 7, min , 8 min, 9 min ,10 min, 11 min, 12 min, 13 min, 14 min, 15 min, 16 min, 17 min, 18 min, 19 min , 20 min, 25 min, 30 min, 35 min, 40 min, 45 min, 50 min, 55 min, 60 min.

Secondary

MeasureTime frame
1. To compare incidence of post-delivery hypotension 2. To compare maternal blood pressure (SBP, DBP, MAP) 3. To compare total dose of vasopressor (phenylephrine) required 4. To compare incidence of maternal bradycardia (HR 50/min) 5. To compare incidence of nausea and vomiting 6. To compare neonatal outcomes (APGAR Score and umbilical cord PH) 7. To compare maternal blood sugar levels Timepoint: Post spinal Intraoperatively 1min, 2min, 3min, 4 min, 5 min, 6 min, 7, min , 8 min, 9 min ,10 min, 11 min, 12 min, 13 min, 14 min, 15 min, 16 min, 17 min, 18 min, 19 min , 20 min, 25 min, 30 min, 35 min, 40 min, 45 min, 50 min, 55 min, 60 min. Postoperatively at 1 Hr, 2 Hr

Countries

India

Contacts

Public ContactSri vidyadhari Duttala

AIIMS JODHPUR

kamlesh.gmch@gmail.com9780040150

Outcome results

None listed

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