A clinical trial to study the comparison of prophylactic norepinephrine and phenylephrine intravenous infusion for the treatment of post spinal anaesthesia induced hypotension in elderly patients

Comparison of prophylactic equipotent norepinephrine and phenylephrine infusion for the treatment of post spinal anaesthesia induced hypotension - a prospective double blinded randomized controlled clinical trial - nil

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/08/071767

Enrollment

108

Registered

2024-08-01

Start date

Unknown

Completion date

Unknown

Last updated

2024-08-19

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: Norepinephrine: 9 micrograms per ml per minute over 45 minutes as infusion started after 1 minute following spinal anaesthesia Control Intervention1: Phenylephrine: 100 micrograms per m

Eligibility

Inclusion criteria

Inclusion criteria: (1) Elderly patients (more than 50 years) who are scheduled for surgery under spinal anaesthesia (2) Patients of American society of anaesthesiologists I,II,III

Exclusion criteria

Exclusion criteria: Contraindication of spinal anaesthesia. History of allergy to any of the study drugs. Patients with cardiac morbidities. Hypertensive patients. Patients with advanced comorbidity like hyperthyroidism and autonomic neuropathy. Patients on heart rate regulating drugs.

Design outcomes

Primary

Measure	Time frame
Incidence of spinal anaesthesia induced hypotension where mean arterial pressure is less than 80% of the baseline reading for 45 minutes and not related to blood lossTimepoint: At baseline, each minute for the first 10 minutes, every 3rd minute for the next 35 minutes after induction of spinal anesthesia	—

Secondary

Measure	Time frame
1.Mean heart rate beats per minute 2.The proportion of patients having bradycardia with heart rate less than 50 beats per minute. 3.Incidence of reactive hypertension increased mean arterial pressure with more than 25% of the baseline reading. 4.The proportion of patients requiring rescue boluses of ephedrine. 5.Any other adverse events.Timepoint: 1. From 2 minutes to 45 minutes after induction of spinal anaesthesia. 2. From 1 minute to 45 minutes after induction of spinal anaesthesia. 3. From 1 minute to 45 minutes after induction of spinal anaesthesia. 4.From 1 minute to 45 minutes after induction of spinal anaesthesia. 5. Within 24 hours	—

Measure

Time frame

1.Mean heart rate beats per minute 2.The proportion of patients having bradycardia with heart rate less than 50 beats per minute. 3.Incidence of reactive hypertension increased mean arterial pressure with more than 25% of the baseline reading. 4.The proportion of patients requiring rescue boluses of ephedrine. 5.Any other adverse events.Timepoint: 1. From 2 minutes to 45 minutes after induction of spinal anaesthesia. 2. From 1 minute to 45 minutes after induction of spinal anaesthesia. 3. From 1 minute to 45 minutes after induction of spinal anaesthesia. 4.From 1 minute to 45 minutes after induction of spinal anaesthesia. 5. Within 24 hours

—

Countries

India

Contacts

Public ContactDr Aloka Samantaray

Sri Venkateswara Institute of Medical Sciences

aloksvims@gmail.com9493547653

Outcome results

None listed

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