Skip to main content
Clinical Trials/CTRI/2024/03/064165
CTRI/2024/03/064165CompletedPhase 4

A randomised double blinded study comparing prophylactic noradrenaline infusion and phenylephrine infusion after preloading with crystalloid for prevention of hypotension in geriatric patients undergoing proximal femoral nailinig under spinal anaesthesia.

Dr Tharigonda Balaji1 site in 1 country60 target enrollmentStarted: March 28, 2024Last updated:

Trial Snapshot

Phase
Phase 4
Status
Completed
Sponsor
Enrollment
60
Locations
1
Primary Endpoint
Prevention Of Spinal Hypotension

Study Overview

Brief Summary

Aim of this study is to compare effectiveness of prophylactic norepinephrine infusion and phenylephrine infusion after preloading with crystalloid in preventing hypotension.The primary objective of this study is  to compare the effect of prophylactic norepinephrine infusion and phenylephrine infusion after preloading with crystalloid in preventing hypotension in geriatric patients undergoing proximal femoral nailing surgeries under spinal anaesthesia. Secondary objectives are to assess the incidence of adverse events between the two groups. Total number of 60 patients between the age group of 65-80years, belonging to ASA physical status ii/iii, posted for proximal femoral  nailing surgeries under spinal anaesthesia will be recruited and randomly assigned into two equal groups using computer generated random list. All patients will be preloaded with crystalloids 10ml/kg. After preloading the patients with crystalloids 10ml/kg, subarachnoid block will be achieved with intrathecal 0.5% bupivacaine heavy 2.5ml combined with 25 mics fentanyl. Immediately following subarachnoid block, patients in Group A (n-30) will  receive inj.phenylephrine infusion at rate of  0.5mcg/kg/min and patients in Group B (n-30) will receive  inj.norepinephrine infusion at rate of 0.05 mcg/kg/min. Haemodynamic parameters including mean arterial pressure (MAP) and heart rate (HR) will be assessed. Adverse events such as bradycardia, nausea and vomiting  will  also be recorded. Data will be analysed with chi- square test and student-t test.

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
Participant and Investigator Blinded

Eligibility Criteria

Ages
65.00 Year(s) to 80.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • 1.ASA 2 & 3 2.Aged between 65 – 80 yrs.

Exclusion Criteria

  • 1.Patients with known cardiac abnormalities.
  • 2.Uncontrolled hypertension.
  • 3.Hyperthyroid patients.
  • 4.Coagulation or renal disorders.
  • 5.Infection at the site of spinal anaesthesia.

Outcomes

Primary Outcomes

Prevention Of Spinal Hypotension

Time Frame: heart rate and mean arterial blood pressure at Baseline, every 5 min for first half an hour, every 10 min for next 90 min

Secondary Outcomes

  • Adverse events such as bradycardia, nausea and vomiting will be recorded(intra operative period and 6 hrs post operatively)

Investigators

Sponsor
Dr Tharigonda Balaji
Sponsor Class
Other [self]
Responsible Party
Principal Investigator
Principal Investigator

Tharigonda Balaji

Government Medical College,Kadapa

Study Sites (1)

Loading locations...

Similar Trials