Comparative Assessment of Ephedrine and Phenylephrine for Treating Hypotension During Spinal Anaesthesia for Caesarean Delivery

Prospective Comparative Evaluation of Ephedrine and Phenylephrine Boluses for the Treatment of Hypotension During Caesarean Section Under Spinal Anaesthesia - Nil

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/05/110992

Enrollment

Registered

2026-05-25

Start date

Unknown

Completion date

Unknown

Last updated

2026-06-01

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

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: Group E (Ephedrine Group) Intravenous Bolus Ephedrine Group P (Phenylephrine Group) Intravenous Bolus Phenylephrine: Group E Ephedrine Group Patients developing hypotension foll

Eligibility

Inclusion criteria

Inclusion criteria: Pregnant women scheduled for elective caesarean section under spinal anaesthesia. American Society of Anesthesiologists (ASA) physical status II. Singleton term pregnancy (more than 37 weeks gestation). Patients willing to participate and provide written informed consent

Exclusion criteria

Exclusion criteria: Patients with pregnancy-induced hypertension, preeclampsia, or eclampsia. Known cardiovascular disease, arrhythmias, or uncontrolled hypertension. Contraindication to spinal anaesthesia. Allergy or hypersensitivity to Ephedrine or Phenylephrine.. Baseline bradycardia (heart rate less than 60 bpm) or tachycardia (more than 120 bpm). Patients receiving medications affecting cardiovascular responses (e.g., beta blockers).

Design outcomes

Primary

Measure	Time frame
Effectiveness of intravenous bolus Ephedrine versus Phenylephrine in the management of spinal anaesthesia-induced hypotension during caesarean section, assessed by maintenance of systolic blood pressure within 20percent of baseline values.Timepoint: 1. Baseline Before administration of spinal anaesthesia 2. Immediately after spinal anaesthesia 3. At onset of hypotension 4. 1 minute after vasopressor bolus administration 5. 3 minutes after vasopressor bolus administration 6. 5 minutes after vasopressor bolus administration 7. Every 5 minutes thereafter until delivery of the baby 8. At the end of surgery/intraoperative period	—

Measure

Time frame

Effectiveness of intravenous bolus Ephedrine versus Phenylephrine in the management of spinal anaesthesia-induced hypotension during caesarean section, assessed by maintenance of systolic blood pressure within 20percent of baseline values.Timepoint: 1. Baseline Before administration of spinal anaesthesia 2. Immediately after spinal anaesthesia 3. At onset of hypotension 4. 1 minute after vasopressor bolus administration 5. 3 minutes after vasopressor bolus administration 6. 5 minutes after vasopressor bolus administration 7. Every 5 minutes thereafter until delivery of the baby 8. At the end of surgery/intraoperative period

—

Secondary

Measure	Time frame
Changes in HR, SBP, DBP, & MAP. Incidence of bradycardia & tachycardia. Total vasopressor requirement. Number of rescue boluses required. Maternal adverse effects such as nausea & vomiting. Incidence of recurrent hypotension. Neonatal APGAR scores at 1 & 5 minutes.Timepoint: 1. Baseline before spinal anaesthesia 2. At 2-minute intervals after spinal anaesthesia until stabilization of blood pressure 3. At delivery of the baby 4. At placental delivery 5. At the end of surgery 6. Postoperative period (30 minutes to 1 hour after surgery)	—

Measure

Time frame

Changes in HR, SBP, DBP, & MAP. Incidence of bradycardia & tachycardia. Total vasopressor requirement. Number of rescue boluses required. Maternal adverse effects such as nausea & vomiting. Incidence of recurrent hypotension. Neonatal APGAR scores at 1 & 5 minutes.Timepoint: 1. Baseline before spinal anaesthesia 2. At 2-minute intervals after spinal anaesthesia until stabilization of blood pressure 3. At delivery of the baby 4. At placental delivery 5. At the end of surgery 6. Postoperative period (30 minutes to 1 hour after surgery)

—

Countries

India

Contacts

Public ContactParvathareddy sri sai jaswanth

Vinayaka Missions Kirupananda Variyar Medical College and Hospitals

sabapathyv.appavoo@gmail.com9442566989

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 11, 2026