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.
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
Tharigonda Balaji
Government Medical College,Kadapa
