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 planned caesarean section

Effect of different doses of phenylephrine hydrochloride for treatment of hypotension during spinal anaesthesia in patients undergoing elective caesarean section

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2011/12/002294

Enrollment

Registered

2011-12-26

Start date

Unknown

Completion date

Unknown

Last updated

2023-08-21

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 - Phenylephrine hydrochloride 125 microg intravenously after development of hypotension, additional boluses of 25 microg every minute i

administration of 62.5 microg (half of initial dose) to treat second episode of hypotension Intervention2: Phenylephrine hydrochloride 150 microg: 3rd group - 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 - Phenylephrine hydrochloride 100

administration of 50 microg (half of initial dose) to treat second episode of hypotension

Eligibility

Inclusion criteria

Inclusion criteria: ASA I or II females with term, uncomplicated, singleton pregnancy undergoing elective LSCS under spinal anaesthesia Patients who develop hypotension after subarachnoid block will be included Hypotension after spinal anaesthesia will be defined as a fall of > 20% from the baseline or an absolute value of less than 100 mm Hg systolic blood pressure

Exclusion criteria

Exclusion criteria: Maternal complications e.g. diabetes, pregnancy induced hypertension, cardiovascular disease, cerebrovascular disease Placental complications viz., placenta praevia or abruptio placentae Cord complications viz., nuchal cord or cord prolapse Foetal malformations 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 Patients with baby birth weight less than 2.5 kg or greater than 4.5 kg

Design outcomes

Primary

Measure	Time frame
Umbilical arterial pH, incidence of foetal acidosis APGAR scores Efficacy to treat post-spinal hypotension Timepoint: After delivery	—

Secondary

Measure	Time frame
Maternal complications, if any Incidence of reactive hypertension 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

priyankahsinghani@gmail.com9910137941

Outcome results

None listed

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