| CTRI Number |
CTRI/2020/07/026760 [Registered on: 24/07/2020] Trial Registered Prospectively |
| Last Modified On: |
23/07/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
An observational analytical study |
| Study Design |
Other |
|
Public Title of Study
|
Effects of different anaesthetic techniques on blood parameters in patients undergoing surgery |
|
Scientific Title of Study
|
Effects of different anaesthetic techniques on neutrophil lymphocyte ratio and monocyte lymphocyte ratio in patients undergoing major non-cardiac surgery: An observational analytical study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Priyanka Boruah |
| Designation |
Junior Resident |
| Affiliation |
All India Institute of Medical Sciences, Rishikesh |
| Address |
Department of anaesthesiology,level 6,
AIIMS, Rishikesh
Dehradun
UTTARANCHAL
249203
India |
| Phone |
8638839968 |
| Fax |
|
| Email |
priyankaborauhgmc90@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Priyanka Boruah |
| Designation |
Junior Resident |
| Affiliation |
All India Institute of Medical Sciences, Rishikesh |
| Address |
Department of anaesthesiology,
Level 6,
AIIMS, Rishikesh
Dehradun
UTTARANCHAL
249203
India |
| Phone |
8638839968 |
| Fax |
|
| Email |
priyankaborauhgmc90@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Priyanka Boruah |
| Designation |
Junior Resident |
| Affiliation |
All India Institute of Medical Sciences, Rishikesh |
| Address |
Girls Hostel, AIIMS Rishikesh campus, Rishikesh
Girls Hostel, AIIMS Rishikesh campus, Rishikesh
Dehradun
UTTARANCHAL
249203
India |
| Phone |
8638839968 |
| Fax |
|
| Email |
priyankaborauhgmc90@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology, Level 6, All India Institute of Medical Sciences, veer Bhadra marg, Rishikesh-249203. |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences Rishikesh |
| Address |
Veer Bhadra Road, Rishikesh 249201 |
| 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 |
| Bhavna Gupta |
AIIMS hospital |
Department of Anesthesia, 6th Floor, AIIMS hospital Vir-bhadra Marg Rishikesh uttrakhand
Garhwal
UTTARANCHAL
Garhwal
UTTARANCHAL |
8527686660
bhavna.kakkar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
fit and healthy individuals |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1)ASA grade I and II.
2)Patient undergoing major abdominal surgery, orthopedic surgery, Gynaecological surgery and spine surgery. |
|
| ExclusionCriteria |
| Details |
1)Any contraindication to spinal anesthesia and General anesthesia.
2)Patients with existing acute infection and, sepsis.
3)Patients on recent chemotherapy.
4)Patients on chronic treatment with steroids or immunosuppressants.
5) Patients who are morbidly obese and have autoimmune disease.
6)Patients underwent blood transfusion for < 1 week.
7) Patients not willing to give consent. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1)To predict the delta change in Neutrophil Lymphocyte ratio and monocyte lymphocyte ratio at various time points. |
pre-operatively, immediately post surgery, 6 hours and 24 hours post surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To predict acute complications like hypotension, headache, nausea and vomiting, fever. |
Within 24 hours of surgery |
|
|
Target Sample Size
|
Total Sample Size="300"
Sample Size from India="300"
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)
|
31/07/2020 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is an observational analytical study where the effects of different anaesthetic techniques on neutrophil lymphocyte ratio and monocyte lymphocyte ratio in patients undergoing major non cardiac surgery will be studied in various time Line. Three groups allocated (Total intravenous anesthesia, neuraxial block, balance anesthesia) and blood sample of CBC will be sent preoperatively, at the end of surgery, 6 hours and 24 hours after surgery. Total of 300 patient of either sex of age group 18 to 70 years belonging to ASA physical status 1 and 2, excluding patients who have any contraindication to spinal anesthesia and General anesthesia patients with coexisting acute infection and sepsis, patients on recent chemotherapy, patients on chronic treatment with steroids or immunosuppressants, patients who are morbidly obese and have autoimmune disease, patients underwent blood transfusion for < 1 week, patients not willing to give consent. |