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Clinical Trials/CTRI/2023/04/051451
CTRI/2023/04/051451Not yet recruitingNot Applicable

A Comparative study of infusion of Ephedrine and Phenylephrine on hemodynamic stability after Spinal Anaesthesia in elderly patients undergoing lower limb Orthopaedic Surgeries

Shri B M Patil Medical College1 site in 1 country174 target enrollmentStarted: October 4, 2023Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
174
Locations
1
Primary Endpoint
To compare the effect of Ephedrine and Phenylephrine on hemodynamic stability after spinal anaesthesia

Study Overview

Brief Summary

This study is a Prospective Randomized, Parallel group study. This study consists of 3 groups where Group E who will receive Injection EPHEDRINE 30mg infusion for 30 minutes, Group P who will receive Injection PHENYLEPHRINE 250mcg infusion for 30 minutes and  Control group will receive intravenous bolus injection mephentermine 6mg when required .174 patients posted for lower limb orthopedic surgeries under Spinal Anesthesia will be equally divided into 3 groups as 58 each. The study will be conducted in Shri. BM Patil Medical College Hospital and Research Centre Vijayapura, Karnataka. The primary outcome is to compare the effect of Ephedrine and Phenylephrine on hemodynamic stability after Spinal Anesthesia and secondary outcome is to compare the number of rescue doses of Ephedrine and Phenylephrine given after Spinal Anesthesia.

Study Design

Study Type
Interventional
Allocation
Computer generated randomization
Masking
Not Applicable

Eligibility Criteria

Ages
60.00 Year(s) to 90.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Age above 60 years Patients undergoing lower limb orthopaedic surgeries.

Exclusion Criteria

  • Infection at the site of injection Uncontrolled hypovolemia Allergy or Hypersensitivity to Vasoconstrictors Increased intracranial pressure Coagulopathy,sepsis,fixed cardiac output states,neurological disease Uncontrolled Hypertension,Diabetes Mellitus and Heart failure Phaeochromocytoma Hypothyroidism MAO inhibitors,Tricyclic Antidepressants Phenothiazine compounds Recent MI and CABG.

Outcomes

Primary Outcomes

To compare the effect of Ephedrine and Phenylephrine on hemodynamic stability after spinal anaesthesia

Time Frame: 30 minutes

Secondary Outcomes

  • To compare the number of rescue doses of Ephedrine and Phenylephrine given after spinal anaesthesia(30 minutes)

Investigators

Sponsor Class
Private medical college

Study Sites (1)

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