| CTRI Number |
CTRI/2019/04/018512 [Registered on: 09/04/2019] Trial Registered Prospectively |
| Last Modified On: |
08/04/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
In lower limb revascularization surgery done under spinal anaesthesia, assessment of anaesthesia results |
|
Scientific Title of Study
|
Anaesthetic outcome of lower limb revascularizaton surgery done in spinal anaesthesia: A Prospective clinical study of 100 patients |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anjuri Goyal |
| Designation |
PG Resident Doctor in Department of Anaesthesiology |
| Affiliation |
RNT Medical College, Udaipur |
| Address |
Department of Anaesthesiology, RNT Medical College, Udaipur
Udaipur
RAJASTHAN
313001
India |
| Phone |
9468960806 |
| Fax |
|
| Email |
anjurigoyal23@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Udita Naithani |
| Designation |
Professor |
| Affiliation |
RNT Medical College, Udaipur |
| Address |
Department of Anaesthesiology, RNT Medical College, Udaipur
Udaipur
RAJASTHAN
313001
India |
| Phone |
9829414752 |
| Fax |
|
| Email |
uditanaithani@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Udita Naithani |
| Designation |
Professor |
| Affiliation |
RNT Medical College, Udaipur |
| Address |
Department of Anaesthesiology, RNT Medical College, Udaipur
Udaipur
RAJASTHAN
313001
India |
| Phone |
9829414752 |
| Fax |
|
| Email |
uditanaithani@gmail.com |
|
|
Source of Monetary or Material Support
|
| MB hospital, RNT MEDICAL COLLEGE CAMPUS,near court chouraha, Udaipur-313001, Rajasthan |
|
|
Primary Sponsor
|
| Name |
MAHARANA BHUPAL GOVERNMENT HOSPITAL |
| Address |
RNT MEDICAL COLLEGE CAMPUS,near court chouraha, Udaipur-313001, Rajasthan |
| 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 ANJURI GOYAL |
MB Hospital Campus Udaipur |
CARDIOTHORACIC VASCULAR SURGERY(CTVS) Operation Theatre, CTVS department
Udaipur
RAJASTHAN |
9468960806
anjurigoyal23@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, RNT Medical College, Udaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I739||Peripheral vascular disease, unspecified, |
|
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Intervention / Comparator Agent
|
|
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Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
posted for spinal anaesthesia for lower limb revascularization surgery both acute and chronic including emergency and elective |
|
| ExclusionCriteria |
| Details |
Platelet count<1,00,000 /mm3, International normalised ratio(INR) >2.0, Those have continued anticoagulants treatment,Fused spine, Patient not willing, Localised site infection, Severe stenotic valvular disease. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Post operative return of sensory block, Return of motor block, duration of analgesia. |
1 hour after surgery till complete recovery of block |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To observe for complications if any and their treatment and complaints of patient and surgeon regarding anaesthetic technique, if any |
Within 24 hours of surgery |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
20/04/2019 |
| 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
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
To evaluate the anaesthetic outcome of lower limb revascularization surgery performed under spinal anaesthesia.
To observe for complications if any and their treatment and complaints of patient and surgeon regarding anaesthetic technique, if any
|