A comparison of two drugs norepinephrine and phenylephrine to prevent hypotension after spinal anaesthesia in patients above 60 years posted for hip and femur surgery

Not yet recruiting

• Conditions: Hypotension due to drugs,

• Registration Number: CTRI/2023/08/056993
• Lead Sponsor: Dayanand Medical College and Hospital

Brief Summary

Spinal anaesthesia is frequently used for lower extremity surgeries.Sympathetic blockade after spinal anaesthesia results in venodilation which reduces venous return and hence cardiac output and results in hypotension . Therefore, prophylactic use of alpha-adrenergic agonist drugs is recommended which act by inducing constriction of compliant veins , effectively reversing the vasodilatory effects of spinal anaesthesia.

A prospective , interventional , double blinded , randomised study will be conducted on elderly more than 60 years old patients posted for hip and femur surgeries under sub arachnoid block. In this study we aim to compare the effect of using prophylactic Norepinephrine versus Phenylephrine infusion for prevention of spinal induced hypotension in elderly population undergoing hip and femur surgeries.

A randomized controlled trial will be conducted on 134 elderly patients ( > 60 years of age ) undergoing hip and femur surgeries under spinal anaesthesia. An arterial line will be secured using a 20 G arterial cannula in the radial artery. The patients will be divided into two groups: Norepinephrine (NE) and Phenylephrine (PE) -67 each -depending on the drug administered which will be started before giving sub arachnoid block to the patient . All patients will be administered 2.2 ml volume of bupivacaine 0.5% (1.7 ml) with 25 micrograms (0.5 ml) of fentanyl to achieve subarachnoid block Monitoring of invasive arterial blood pressure will be done for first 45 minutes of surgery and readings will be noted every 2 minutes

Detailed Description

Not available

Study Timeline

• Study Start: 2023-07-09
• Last Update Posted: 2023-08-24

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 134

Inclusion Criteria

Elderly patients above 60 years of age posted for hip and femur surgeries.

Exclusion Criteria

• Patients with history of allergy to any of the study drugs 2.
• Patients with contraindications of spinal anaesthesia 3.
• Patient refusal.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Episodes of hypotension (defined as Systolic blood pressure less than 80% of baseline or an absolute value of less than 100 mmHg).	Upto 45 minutes after sub arachnoid block

Secondary Outcome Measures

Name	Time	Method
Incidence of hypertension	Upto 45 minutes after sub arachnoid block
Total amount of Phenylephrine or Norepinephrine
Episodes of Bradycardia	Upto 45 minutes after sub arachnoid block

Trial Locations

Locations (1)

Dayanand Medical College and Hospital; 🇮🇳 Ludhiana, PUNJAB, India

Dayanand Medical College and Hospital

🇮🇳Ludhiana, PUNJAB, India

Dr Neeru Luthra

Principal investigator

9815500960

drneeru1977@yahoo.co.in