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CTRI Number  CTRI/2025/11/096906 [Registered on: 04/11/2025] Trial Registered Prospectively
Last Modified On: 31/10/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   comparing effect of different anaesthesia techniques on immune response of the body. 
Scientific Title of Study   Effect Of Different Anaesthetic Techniques On Neutrophil To Lymphocyte Ratio And Systemic Immune Inflammation Index In Patients Undergoing Laparoscopic Tubal Ligation - A Randomised Prospective Observational Study. 
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 Bhukya Ajay 
Designation  Postgraduate in Anaesthesiology 
Affiliation  ESIC Medical College and Hospital 
Address  Department of Anaesthesiology, ESIC Medical College and Hospital, Sanathnagar, Hyderabad, Telangana - 500018

Hyderabad
TELANGANA
500018
India 
Phone  9182803564  
Fax    
Email  bhukyaajay47723@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Pakhare Vandana 
Designation  Assistant professor 
Affiliation  ESIC Medical College and Hospital 
Address  Department of Anaesthesiology, ESIC Medical College and Hospital, Sanathnagar, Hyderabad, Telangana - 500018

Hyderabad
TELANGANA
500018
India 
Phone  8143364196  
Fax    
Email  vandanapakhare@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Bhukya Ajay 
Designation  Postgraduate in Anaesthesiology 
Affiliation  ESIC Medical College and Hospital 
Address  Department of Anaesthesiology, ESIC Medical College and Hospital, Sanathnagar, Hyderabad, Telangana - 500018

Hyderabad
TELANGANA
500018
India 
Phone  9182803564  
Fax    
Email  bhukyaajay47723@gmail.com  
 
Source of Monetary or Material Support  
Esic medical College and Hospital, Sanathnagar, Hyderabad 
 
Primary Sponsor  
Name  ESIC Medical College and Hospital 
Address  Department of Anaesthesiology, ESIC Medical College, Sanathnagar, Hyderabad-500018 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr vandana pakhre  Esi Hospital, Sanathnagar, Hyderabad, Telangana - 500018  Room no.3021, 3rd Floor OT Complex, Department of Anaesthesiology, ESIC Medical College and Hospital, Sanathnagar, Hyderabad, Telangana - 500018
Hyderabad
TELANGANA 		 8143364196

vandanapakhare@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Esic Medical College And Hospital & Esic Superspeciality Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Comparator Agent  NLR ratio and SII ratio  Neutrophil to Lymphocyte ratio and SII ratio is by neutrophil count multiplied with platelet count and divided by lymphocyte count 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  35.00 Year(s)
Gender  Female 
Details  1) Women undergoing elective tubal ligation under general Anastasia Or spinal anaesthesia.
2) Belonging to ASA physical status 1 or 2.
3) Aged between 18-35 years. 
 
ExclusionCriteria 
Details  1) Refusal to participate
2) Active infections or recent illness
3) Immunocompromised state
4) Chronic inflammatory conditions like SLE or RA 5) Morbid obesity 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To calculate the neutrophil lymphocyte ratio from blood counts on the day of surgery and compare the value with the neutrophil lymphocyte ratio obtained on post operative day 1 ie; 24 hours later.  T1: just before surgey starts.
T2-24hrs after surgery. 
 
Secondary Outcome  
Outcome  TimePoints 
To calculate the systemic immune inflammatory index from the routine blood counts on the day of surgery and to compare it with the value obtained 24 hours later.  1st: just before surgey starts.
2nd: 24hrs after 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   N/A 
Date of First Enrollment (India)   01/01/2026 
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response (Others) -  the identified data will be provided after receiving methodological sound proposal to emial id - vandanapakhare@gmail.com

  6. For how long will this data be available start date provided 01-01-2026 and end date provided 31-12-2026?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Following approval from ethical committee and written informed consent from the patients. The study subjects would be divided into two groups. Group G would receive general anaesthesia and group S would receive spinal anaesthesia. The patients would be randomly allocated to one of the two groups. All patients will be assessed preoperatively and informed both techniques of anaesthesia and their risks and benefits. The patients would be fasted according to current anaesthetic guidelines. Preoperative haemoglobin levels, total leukocyte counts, differential count, NLR and systemic immune inflammation index would be evaluated along with the other necessary routine investigations. On the day of surgery, IV access will be established and balanced salt solution will be commenced. All patients will be monitored using NIBP, SPo2 and ETCO2. Baseline hemodynamic parameters will be recorded. Patients allocated to group G would be induced with propofol 2mg/kg and muscle relaxation achieved with vecuronium 0.1mg/kg IV. Following ventilation with oxygen, air and sevoflurane for 3 minutes, the trachea would be intubated with size 7mm tracheal tube and anaesthesia would be maintained with oxygen and air mixture 1-2% sevoflurane titrated to maintained the hemodynamic parameters within 15-20% of basal readings. Additional muscle relaxation for top up would be administered using vecuronium 0.05mg/kg as needed. Following completion of surgery, patients would be extubated after antagonism of residual neuromuscular blockade using glycopyrrolate 0.01mg/kg and neostigmine 0.05 mg/kg. Patient allocated to the spinal anaesthesia group would receive 0.5% heavy bupivacaine at T10 interspace in the sitting position using a volume of 1.8 ml. ECG, NIBP and SPO2 would be monitored continuously throughout the procedure. Any decrease in blood pressure would be corrected immediately by the administration of phenylephrine 50 micrograms boluses to maintain the arterial blood pressure within 20% of a baseline values. 
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