SE OF DEXAMETHASONE FOR PREVENTION OF HYPOTENSION AFTER SPINAL ANAESTHESIA IN PREGNANT FEMALE UNDERGOING CAESAREAN SECTIO
Phase 3
Completed
- Conditions
- Health Condition 1: 1- Obstetrics
- Registration Number
- CTRI/2022/09/045754
- Lead Sponsor
- AIIMS JODHPUR
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 170
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
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 < 150 cm or body mass index > 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)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 1.To compare incidence of post-delivery hypotension <br/ ><br>2.To compare maternal blood pressure (SBP, DBP, MAP) <br/ ><br>3.To compare total dose of vasopressor (phenylephrine) required <br/ ><br>4.To compare incidence of maternal bradycardia (HR 50/min) <br/ ><br>5.To compare incidence of nausea and vomiting <br/ ><br>6.To compare neonatal outcomes (APGAR Score and umbilical cord PH) <br/ ><br>7.To compare maternal blood sugar levels <br/ ><br> <br/ ><br>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. <br/ ><br>Postoperatively at 1 Hr, 2 Hr