| CTRI Number |
CTRI/2025/03/081552 [Registered on: 03/03/2025] Trial Registered Prospectively |
| Last Modified On: |
28/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
End tidal carbondioxide changes in lower limb surgeries under central neuraxial blockade. |
|
Scientific Title of Study
|
A prospective observational study to assess the end tidal carbondioxide changes in lower limb surgeries under central neuraxial blockade. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Amey Ajit Inamdar |
| Designation |
Junior Resident |
| Affiliation |
Bharati Vidyapeeth Deemed to be University Pune |
| Address |
Department of Anaesthesia
Bharati Vidyapeeth Deemed to be University Pune
Pune
MAHARASHTRA
411043
India |
| Phone |
9168444448 |
| Fax |
|
| Email |
ameyinamdar2007@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrSarojini Bobde |
| Designation |
Professor |
| Affiliation |
Bharati Vidyapeeth Deemed to be University Pune |
| Address |
Department of Anaesthesia
Bharati Vidyapeeth Deemed to be University Pune
Pune
MAHARASHTRA
411043
India |
| Phone |
9822914122 |
| Fax |
|
| Email |
sarojini.bobde@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Amey Ajit Inamdar |
| Designation |
Junior Resident |
| Affiliation |
Bharati Vidyapeeth Deemed to be University Pune |
| Address |
Department of Anaesthesia
Bharati Vidyapeeth Deemed to be University Pune
Pune
MAHARASHTRA
411043
India |
| Phone |
9168444448 |
| Fax |
|
| Email |
ameyinamdar2007@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bharati Vidyapeeth Deemed to be University,Pune - Satara Rd, Bharati Vidyapeeth Campus, Dhankawadi, Pune, Maharashtra 411043
|
|
|
Primary Sponsor
|
| Name |
Dr Amey Ajit Inamdar |
| Address |
Department of Anaesthesia
Bharati Vidyapeeth Deemed to be University Pune |
| Type of Sponsor |
Other [(self)] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Sarojini Bobde |
Department of Anaesthesia
Bharati Vidyapeeth Deemed to be University Pune |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Amey Ajit Inamdar |
Bharati Hospital and Research Centre |
Major operation theatre,3rd floor,Bharati Hospital and Research Centre,pune-satara road,pincode:411043
Pune
MAHARASHTRA |
9168444448
ameyinamdar2007@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Bharati Vidyapeeth Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: V061||Pedestrian injured in collision with other nonmotor vehicle in traffic accident, (2) ICD-10 Condition: V061||Pedestrian injured in collision with other nonmotor vehicle in traffic accident, (3) ICD-10 Condition: V061||Pedestrian injured in collision with other nonmotor vehicle in traffic accident, (4) ICD-10 Condition: V061||Pedestrian injured in collision with other nonmotor vehicle in traffic accident, (5) ICD-10 Condition: V061||Pedestrian injured in collision with other nonmotor vehicle in traffic accident, (6) ICD-10 Condition: V061||Pedestrian injured in collision with other nonmotor vehicle in traffic accident, (7) ICD-10 Condition: V00-V09||Pedestrian injured in transport accident, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
88.00 Year(s) |
| Gender |
Both |
| Details |
individuals undergoing lower limb surgeries |
|
| ExclusionCriteria |
| Details |
1)Individuals not willing to participate in the study.
2) Patients with contraindication to central neuraxial blockade.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Effect of raised Etco2 |
3 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| weather requires further intervention |
3 years |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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)
|
15/03/2025 |
| 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="3"
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 - NO
|
|
Brief Summary
|
This is a prospective observational study to asses the End CO2 in patients who are being posted for lower limb surgeries under central neuraxial blockade.In orthopedic lower limb surgeries there is use of tourniquet which can cause hemodynamic changes after release of the tourniquet. With the help if this study i am trying to look for early indication of these complications. |