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Clinical Trials/CTRI/2024/07/070663
CTRI/2024/07/070663
Recruiting
Phase 2

Comparison Of Effects Of Trendelenburg 20 Degree, Passive Leg Raising At 45 Degree And Supine Position On The Hemodynamic Changes After Tourniquet Deflation In Orthopaedic Lower Limb Surgery Under Spinal Anaesthesia - A Prospective Parallel Controlled Study

Deen Dayal Upadhyay Hospital1 site in 1 country90 target enrollmentStarted: July 26, 2024Last updated:

Overview

Phase
Phase 2
Status
Recruiting
Enrollment
90
Locations
1
Primary Endpoint
to evaluate the effect of tredenlenberg 20 degree position,passive leg raise at 45 degree and supine position on mean arterial pressure and heart rate after 5 minutes of torniquet deflation

Overview

Brief Summary

It is a Prospective Parallel Controlled Study to Compare the effect of Trendelenburg 20 degree position, Passive leg raising at 45 degree and Supine position on hemodynamic changes after tourniquet deflation in patients undergoing Orthopaedic lower limb surgery under Spinal Anaesthesia. Here patients will be allocated into 3 study group by block randomisation with sealed envelope system. We will prepare fifteen randomly generated treatment allocations within sealed opaque envelopes assigning T, P and C in 5 envelopes each, where T represents Trendelenburg 20degree group, P represents PLR 45 degree group and C represents control group with supine position. Once a patient will consent to enter a trial, an envelope will be opened and the patient will then be offered the allocated group. In this technique, patients will be randomised in a series of blocks of fifteen.After whic hemodynamic parameters will be monitored and recorded at baseline,0,1,2,3,4,5,10,20,30 minutes and need of vasopressors and IV fluid usuage, Torniquet inflation and Deflation time will be recorded.

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
None

Eligibility Criteria

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

Inclusion Criteria

  • ASA(American society of Anaesthesiologist) Physical status grade I/II
  • Age from 18 to 60 years and All sexes
  • Patients undergoing Orthopaedics lower limb surgeries along with use of torniquet under spinal anaesthesia
  • Patients undergoing Orthopaedics lower limb surgeries whose duration of surgery is more than 1 hour.

Exclusion Criteria

  • Patients with any history of cardiovascular illness
  • Patients requiring bilateral lower limb surgery
  • Any allergy to local anaesthetic drugs
  • Any contraindication for spinal anesthesia
  • Patients undergoing lower limb vascular surgeries
  • Surgeries exceeding allowable tourniquet time
  • Intraoperative hemodynamic instability.

Outcomes

Primary Outcomes

to evaluate the effect of tredenlenberg 20 degree position,passive leg raise at 45 degree and supine position on mean arterial pressure and heart rate after 5 minutes of torniquet deflation

Time Frame: to evaluate the effect of tredenlenberg 20 degree position,passive leg raise at 45 degree and supine position on mean arterial pressure and heart rate after 5 minutes of torniquet deflation

Secondary Outcomes

  • To compare(1. Systolic Blood Pressure (SBP) among Trendelenburg 20 degree position, Passive leg raising at 45 degree & supine position after tourniquet deflation.)

Investigators

Sponsor Class
Other [self]
Responsible Party
Principal Investigator
Principal Investigator

Dr Upasana Goswami

Deen Dayal Upadhyay Hospital

Study Sites (1)

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