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Study on controlling Blood pressure in Lower segment caesarean section (LSCS)

A Randomized Control Trial comparing the effect of phenylephrine by intramuscular route with intravenous infusion in maintaining hemodynamic stability during elective lower segment caesarean section under spinal anaesthesia

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/06/043359
Enrollment
150
Registered
2022-06-20
Start date
Unknown
Completion date
Unknown
Last updated
2022-06-27

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

Conditions

None listed

Interventions

Intervention1: Injection Phenylephrine: single dose Injection Phenylephrine 1.5mg through intramuscular route 15 minutes before the administration of spinal anesthesia Control Intervention1: Injection

Sponsors

SRM medical college hospital and Research centre
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1)singleton pregnancy at term posted for elective cesarean section 2)height from 150 cm to 180 cm 3)American Society of Anesthesiologists (ASA) II grade 4)BMI less than 40 kg/m2

Exclusion criteria

Exclusion criteria: 1) multiple pregnancy 2) contraindications for spinal anesthesia 3) parturients with comorbidities: gestational or nongestational hyptertension, eclampsia, etc. 4) preoperative history of bradycardia (heart rate (HR) less than 60 bpm 5) fetal complications: fetal macrosomia, fetal malformation, fetal distress in uterus, etc. 6) participants refused to sign informed consent

Design outcomes

Primary

MeasureTime frame
intraoperative Systolic Blood Pressure, Diastolic Blood Pressure, Mean arterial pressure, Heart rateTimepoint: At baseline

Secondary

MeasureTime frame
neonatal outcomes: 1) UA blood gas analysis values: pH, base excess (BE), lactate, PaO2, PaCO2; 2) the incidence of fetal acidosis (UA pH 7.20)Timepoint: After baby delivery;Maternal outcomes: 1) the incidence of, nausea and vomiting; 3) time to first use of rescue phenylephrine after anaesthesia (completion of the subarachnoid injection will be defined as 0 time point) 4) Total number of rescue phenylephrine doses needed during surgery 5) Total number of rescue atropine needed during surgery 6)Adverse effects: bradycardia, hypertension, hypotension, nausea and vomitingTimepoint: At baseline

Countries

India

Contacts

Public ContactChandrekanth

SRM Medical College Hospital and Research Centre

gayathrii.r@gmail.com9500092905

Outcome results

None listed

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