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Clinical Trials/CTRI/2025/04/083905
CTRI/2025/04/083905Not yet recruitingNot Applicable

A prospective observational study to assess the transverse diameter and peak velocity of right common femoral vein by ultrasound in the supine position for the prediction of post spinal anaesthesia hypotension in elective infraumbilical surgeries at S.M.S.Medical college Jaipur

S.M.S. Medical college and hospital1 site in 1 country60 target enrollmentStarted: April 15, 2025Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
60
Locations
1
Primary Endpoint
To estimate the association between ultrasonographic measurment of transverse diameter and peak velocity of right common femoral vein and post-spinal anaesthesia hypotension.

Study Overview

Brief Summary

This study is a prospective observational double blinded study predicting post spinal anaesthesia hypotension by ultrasonographic measurments of transverse diameter and peak velocity of right common femoral vein in 60 patients posted for elective infraumbilical surgeries.So that we can identify the patients at risk of post spinal anaesthesia hypotension even before giving spinal anaesthesia and to reserve fluid for susceptible patients.Patients will be selected according to inclusion and exclusion criteria.Preoperative fasting will be advised atleast for 6h.Monitores will be attached and baseline parameters reviewed.Ultrasound measurments will be performed in the preoperative room in supine position 15 min. before the anaesthesia.A peripheral intravenous line will be secured with an 18G IV cannula.Spinal anaesthesia will be performed under all asepectic precautions at L3-L4 vertebral level in sitting/lateral decubitus position using 0.5% Bupivacaine+Fentanyl 25mcg via a 25G spinal needle.Patients will be returned to.supine position and sensory block assessed.Patients will be excluded from the study if adequate level not attained after spinal anaesthesia.Lactated ringers solution at an open co-loaded infusion rate of 1ml/kg/min. will be administered.Vitals will be recorded non invasively at 0,1,3,5,10,15,30,45,60,75,90 min.after spinal anaesthesia.Bolus ringer lactate and mephentermine 6mg will be administered if hypotension developes and it will be repeated till the hypotension is corrected.After surgery patient will be shifted to recovery room.

Study Design

Study Type
Observational

Eligibility Criteria

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

Inclusion Criteria

  • 1.Patients posted for elective infraumbilical surgeries under spinal anaesthesia.
  • 2.Age group 18 to 60 years.
  • 3.Patients giving written and informed consent for the procedure.
  • 4.Patient belonging to American society of anesthesiology(ASA) physical status classes 1 and 2.

Exclusion Criteria

  • 1.Absolute contraindications to spinal anaesthesia.
  • 2.Morbid obese patients(BMI more than 36 kg/m2) 3.Patient should not be a part of any other study.
  • 4.Preexisting hypotension (SBP less than 90mmHg) and uncontrolled hypertension(BP more than 150/90 mmHg).

Outcomes

Primary Outcomes

To estimate the association between ultrasonographic measurment of transverse diameter and peak velocity of right common femoral vein and post-spinal anaesthesia hypotension.

Time Frame: Monitoring vitals at 0,1,3,5,10,15,30,45,60,75,90 min.following spinal anaesthesia

Secondary Outcomes

  • To estimate the association between ultrasonographic measurment of anteroposterior(AP) diameter and peak velocity of IVC and post-spinal anaesthesia hypotension.
  • To assess and compare the total dose of mephentermine used in each group.(After spinal anaesthesia to the end of surgical procedure)
  • To assess and compare the total fluid given in each group.(After spinal anaesthesia to the end of surgical procedure)
  • To assess and compare the proportion of side(effects if any(Bradycardia,nausea,vomiting,dyspnea).)

Investigators

Sponsor
S.M.S. Medical college and hospital
Sponsor Class
Government medical college

Study Sites (1)

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