| CTRI Number |
CTRI/2025/09/094800 [Registered on: 15/09/2025] Trial Registered Prospectively |
| Last Modified On: |
14/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Observational, Prospective and Comparative Clinical study |
| Study Design |
Other |
|
Public Title of Study
|
Study Comparing Two Types of Anaesthesia on Immune Cell Ratios During Lower Abdominal Surgery |
|
Scientific Title of Study
|
The effect of two anaesthetic techniques On Neutrophil Lymphocyte Ratio(NLR) and Monocyte Lymphocyte Ratio(MLR) in
Patients Undergoing Infra Umbilical Surgeries. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kurlapalli Karthik Achari |
| Designation |
PG STUDENT |
| Affiliation |
GANDHI MEDICAL COLLEGE, BHOPAL |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY
GANDHI MEDICAL COLLEGE AND ASSOCIATED HAMIDIA HOSPITAL, BHOPAL, MADHYA PRADESH
Bhopal MADHYA PRADESH 462001 India |
| Phone |
7013207633 |
| Fax |
|
| Email |
krishnamachari2017@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
DR URMILA KESHARI |
| Designation |
PROFESSOR |
| Affiliation |
GANDHI MEDICAL COLLEGE, BHOPAL |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY
GANDHI MEDICAL COLLEGE AND ASSOCIATED HAMIDIA HOSPITAL, BHOPAL, MADHYA PRADESH
Bhopal MADHYA PRADESH 462001 India |
| Phone |
9826757745 |
| Fax |
|
| Email |
surmila19@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
DR VARSHA RAMPURI |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
GANDHI MEDICAL COLLEGE, BHOPAL |
| Address |
DEPARTMENT OF PATHOLOGY
GANDHI MEDICAL COLLEGE AND ASSOCIATED HAMIDIA HOSPITAL, BHOPAL, MADHYA PRADESH
Bhopal MADHYA PRADESH 462001 India |
| Phone |
9826364657 |
| Fax |
|
| Email |
varsharampuri@gmail.com |
|
|
Source of Monetary or Material Support
|
| DEPARTMENT OF ANAESTHESIOLOGY
GANDHI MEDICAL COLLEGE BHOPAL MADHYA PRADESH 462001 |
|
|
Primary Sponsor
|
| Name |
GANDHI MEDICAL COLLEGE |
| Address |
GANDHI MEDICAL COLLEGE AND ASSOCIATED HAMIDIA HOSPITAL BHOPAL MADHYA PRADESH 462001 |
| 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 |
| Kurlapalli Karthik Achari |
Hamidia Hospital |
Floor2, Department of Anaesthesiology, Gandhi Medical College, Bhopal, Madhya Pradesh 462001 Bhopal MADHYA PRADESH |
7013207633
krishnamachari2017@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
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 |
General Anaesthesia and Spinal anesthesia |
The effect of two anaesthetic techniques On Neutrophil Lymphocyte Ratio(NLR) and Monocyte Lymphocyte Ratio(MLR) in Patients Undergoing Infra Umbilical Surgeries. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ASA Physical Status I or II ( age group: 20-65 years).
Infra Umbilical surgeries.
Informed consent obtained. |
|
| ExclusionCriteria |
| Details |
1.Active infection or inflammatory disease.
2. Pre-existing acute or chronic infection /systemic
inflammatory conditions.
3. Contraindications to neuraxial anaesthesia (e.g.,
coagulopathies, infection at site..)
4. Chronic steroid use/ immunosuppressive therapy.
5. Conversion to open surgery. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To measure, compare and assess the impact of General
Anaesthesia vs. Sub Arachnoid Block on preoperative, at the end
of the surgery and postoperative Neutrophil lymphocyte ratio
(NLR) and Monocyte lymphocyte ratio (MLR) in patients
undergoing Infra Umbilical surgeries. |
Pre-op, At the end of surgery, post-op 6hrs and 24 hrs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To identify any correlation between altered
NLR/MLR values as markers of systemic
inflammatory and early postoperative clinical
outcomes (e.g, recovery time, pain&
complications) |
Pre-op, At the end of surgery, post-op 6hrs and 24 hrs |
|
|
Target Sample Size
|
Total Sample Size="80" Sample Size from India="80"
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)
|
29/09/2025 |
| 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="6" 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
|
Anaesthetic techniques can modulate the intraoperative and postoperative immune and inflammatory responses. General anaesthesia GA often results in a greater stress response compared to neuraxial techniques like Sub Arachnoid Block SAB which may attenuate these effects by blocking nociceptive input and sympathetic outflow. General Anaesthesia suppresses cell-mediated immunity, affects neutrophil and monocyte activity and can exacerbate systemic inflammation. Sub Arachnoid Block through sympathetic blockade, reduces endocrine-metabolic stress response and improves immune preservation. Elevated NLR Neutrophil lymphocyte ratio and MLR Monocyte Lymphocyte Ratio are associated with increased systemic inflammation and worse surgical outcomes. Both markers are independent predictors of complications, length of stay, and prognosis after surgery. Recent studies support that neuraxial anaesthesia SAB may offer immunological advantages. However, the comparative impact of these techniques on NLR and MLR remains under investigated, particularly in the context of infraumbilical surgeries ,thus necessitating this study. This study aims to fill this gap by evaluating the perioperative at the end of the surgery and postoperative changes in NLR and MLR inflammatory response associated with General Anaesthesia and Sub Arachnoid Block techniques ,contributing to the understanding of immune modulation by anesthetic techniques, aiding in evidence-based anesthesia planning. |