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
Phase 3
- Conditions
- Health Condition 1: O- Medical and Surgical
- Registration Number
- CTRI/2024/08/071767
- Lead Sponsor
- I
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 1.Mean heart rate beats per minute <br/ ><br>2.The proportion of patients having bradycardia with heart rate less than 50 beats per minute. <br/ ><br>3.Incidence of reactive hypertension increased mean arterial pressure with more than 25% of the baseline reading. <br/ ><br>4.The proportion of patients requiring rescue boluses of ephedrine. <br/ ><br>5.Any other adverse events.Timepoint: 1. From 2 minutes to 45 minutes after induction of spinal anaesthesia. <br/ ><br>2. From 1 minute to 45 minutes after induction of spinal anaesthesia. <br/ ><br>3. From 1 minute to 45 minutes after induction of spinal anaesthesia. <br/ ><br>4.From 1 minute to 45 minutes after induction of spinal anaesthesia. <br/ ><br>5. Within 24 hours