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A clinical trial to study the effect of different doses of phenylephrine hydrochloride for treatment of fall in blood pressure during spinal anaesthesia in patients undergoing emergency caesarean section for compromised fetus

Effect of Different doses of phenylephrine hydrochloride for management of post-spinal hypotension during caesarean section in mothers with compromised fetuses

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2012/01/002330
Enrollment
90
Registered
2012-01-10
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- Spinal anaesthesia induced hypotension

Interventions

Intervention1: Phenylephrine hydrochloride 125 microg: 2nd group â?? Phenylephrine hydrochloride 125 microg intravenously after development of hypotension, additional boluses of 25 microg every minute
administration of 62.5 microg (half of initial dose) to treat second episode of hypotension Intervention2: Phenylephrine hydrochloride 150 microg: 3rd group â?? Phenylephrine hydrochloride 150 microg
administration of 75 microg (half of initial dose) to treat second episode of hypotension Control Intervention1: Phenylephrine hydrochloride 100 microg : 1st group â?? Phenylephrine hydrochloride 100

Sponsors

University College of Medical Sciences and Guru Teg Bahadur Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: ASA I or II females with singleton pregnancy undergoing emergency LSCS under spinal anaesthesia due to compromised status of the foetus (foetal distress) Patients who develop hypotension after subarachnoid block will be included Hypotension after spinal anaesthesia will be defined as systolic blood pressure less than 100 mm Hg

Exclusion criteria

Exclusion criteria: • Maternal complications e.g. diabetes, pregnancy induced hypertension, cardiovascular disease, cerebrovascular disease • Patients with absolute or relative contra-indications for spinal anaesthesia e.g.infection in lumbar area, coagulation abnormalities, autonomic neuropathy, spinal deformities, other neurological diseases, hypovolemia due to any cause • Maternal baseline SBP less than 100 mmHg

Design outcomes

Primary

MeasureTime frame
Umbilical arterial pH, Incidence of foetal acidosis, APGAR scores Efficacy to treat post-spinal hypotension Timepoint: After delivery

Secondary

MeasureTime frame
Maternal complications, if any Incidence of bradycardia Timepoint: During study period i.e. till the time of delivery of baby

Countries

India

Contacts

Public ContactDr Medha Mohta

University College of Medical Sciences and Guru Teg Bahadur Hospital

medhamohta@hotmail.com9868399626

Outcome results

None listed

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