| CTRI Number |
CTRI/2025/04/083905 [Registered on: 02/04/2025] Trial Registered Prospectively |
| Last Modified On: |
29/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to assess the measurments of right common femoral vein by ultrasound and post spinal anaesthesia hypotension in elective infraumbilical surgeries |
|
Scientific Title of Study
|
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 |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U1111-1319-9951 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR Satveer Singh Gurjar |
| Designation |
Associate Professor department of Anaesthesiology |
| Affiliation |
S.M.S. Medical college Jaipur Rajasthan |
| Address |
Department of Anaesthesiology,second floor,Dhanwantari building,JLN marg,S.M.S.Medical college,Jaipur,Rajasthan
Jaipur
RAJASTHAN
302004
India |
| Phone |
8890160492 |
| Fax |
|
| Email |
archveer.ss@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR Satveer Singh Gurjar |
| Designation |
Associate Professor department of Anaesthesiology |
| Affiliation |
S.M.S. Medical college Jaipur Rajasthan |
| Address |
Department of Anaesthesiology,second floor,Dhanwantari building,JLN marg,S.M.S.Medical college,Jaipur,Rajasthan
Jaipur
RAJASTHAN
302004
India |
| Phone |
8890160492 |
| Fax |
|
| Email |
archveer.ss@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aishwarya Thakkannavar |
| Designation |
PG student,department of Anaesthesiology |
| Affiliation |
S.M.S.Medical college Jaipur Rajasthan |
| Address |
Department of anesthesiology second floor dhanwantari building JLN Marg S.M.S.Medical college Jaipur Rajasthan
Jaipur
RAJASTHAN
302004
India |
| Phone |
8884752114 |
| Fax |
|
| Email |
aishwaryathakkanavar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology, second floor,dhanwantari building,JLN Marg,S.M.S.medical college Jaipur, Rajasthan,302004 |
|
|
Primary Sponsor
|
| Name |
S.M.S. Medical college and hospital |
| Address |
S.M.S.Medical college and hospital,JLN marg,Jaipur,Rajasthan
302004 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Satveer Singh Gurjar |
S.M.S. Medical college Jaipur Rajasthan |
Department of Anaesthesiology,second floor,Dhanwantari building,JLN marg,S.M.S.Medical college,Jaipur,Rajasthan
Jaipur
RAJASTHAN |
8890160492
archveer.ss@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Office of ethics committee,SMS medical College Jaipur, Rajasthan |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not applicable |
Not applicable |
| Intervention |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
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. |
|
| ExclusionCriteria |
| Details |
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) |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To estimate the association between ultrasonographic measurment of transverse diameter and peak velocity of right common femoral vein and post-spinal anaesthesia hypotension. |
Monitoring vitals at 0,1,3,5,10,15,30,45,60,75,90 min.following spinal anaesthesia |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To estimate the association between ultrasonographic measurment of anteroposterior(AP) diameter and peak velocity of IVC and post-spinal anaesthesia hypotension.
|
Monitoring vitals at 0,1,3,5,10,15,30,45,60,75,90 min.following spinal anaesthesia |
| 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). |
After spinal anaesthesia to the end of surgical procedure |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/04/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) - Study results will be presented in NMC approved journals for publications
- For how long will this data be available start date provided 02-01-1970 and end date provided 02-01-1970?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
|
|
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.
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