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CTRI Number  CTRI/2019/04/018493 [Registered on: 08/04/2019] Trial Registered Prospectively
Last Modified On: 04/09/2019
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Single Arm Study 
Public Title of Study   The effect of combining different anaesthesia techniques on surgical stress and their markers in patients undergoing laparoscopic abdominal surgery. 
Scientific Title of Study   The effect of different anaesthesia techniques combination on surgical stress and inflammatory markers in patients undergoing laparoscopic abdominal surgery. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Neha Singh 
Designation  Associate Professor 
Affiliation  All India Institute of Medical Sciences, Bhubaneswar 
Address  Department of Anaesthesiology All India Institute of Medical Sciences, Sijua, Patrapada, Bhubaneswar, Pin-751019 Odisha, India Khordha ORISSA 751019 India

Khordha
ORISSA
751019
India 
Phone  9438884045  
Fax  0674-2386293  
Email  anaes_neha@aiimsbhubaneswar.edu.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Neha Singh 
Designation  Associate Professor 
Affiliation  All India Institute of Medical Sciences, Bhubaneswar 
Address  Department of Anaesthesiology All India Institute of Medical Sciences, Sijua, Patrapada, Bhubaneswar, Pin-751019 Odisha, India Khordha ORISSA 751019 India

Khordha
ORISSA
751019
India 
Phone  9438884045  
Fax  0674-2386293  
Email  anaes_neha@aiimsbhubaneswar.edu.in  
 
Details of Contact Person
Public Query  
Name  Dr Neha Singh 
Designation  Associate Professor 
Affiliation  All India Institute of Medical Sciences, Bhubaneswar 
Address  Department of Anaesthesiology All India Institute of Medical Sciences, Sijua, Patrapada, Bhubaneswar, Pin-751019 Odisha, India Khordha ORISSA 751019 India

Khordha
ORISSA
751019
India 
Phone  9438884045  
Fax  0674-2386293  
Email  anaes_neha@aiimsbhubaneswar.edu.in  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences, Sijua, Patrapada, Bhubaneswar, PIN-751019 Odisha, India 
 
Primary Sponsor  
Name  Not Applicable 
Address  Not Applicable 
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
not applicable  not applicable 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Neha Singh  All India Institute of Medical Sciences, Bhubaneswar   Theatre Complex, G Block, Near Casualty, Department of Anaesthesiology, AIIMS, Bhubaneswar, Pin-751019 Khordha Odisha Khordha ORISSA
Khordha
ORISSA 		 9438884045

anaes_neha@aiimsbhubaneswar.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, All India Institute of Medical Sciences, Bhubaneswar  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K800||Calculus of gallbladder with acutecholecystitis, (2) ICD-10 Condition: N719||Inflammatory disease of uterus, unspecified, (3) ICD-10 Condition: K358||Other and unspecified acute appendicitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patients posted for elective laparoscopic abdominal surgeries under general anaesthesia. 
 
ExclusionCriteria 
Details  Patients refusing to participate in the study, emergency surgeries, allergy to local anaesthetic drugs. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Effect of different anaesthesia practices on surgical stress and inflammatory markers IL-6, IL-10, TNF-α, C reactive protein and serum cortisol.  During perioperative period 
 
Secondary Outcome  
Outcome  TimePoints 
To find best possible combination for reduction of surgical stress response.   During perioperative period 
 
Target Sample Size   Total Sample Size="10"
Sample Size from India="10" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="10" 
Phase of Trial   N/A 
Date of First Enrollment (India)   08/04/2019 
Date of Study Completion (India) 16/05/2019 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 16/05/2019 
Estimated Duration of Trial   Years="0"
Months="1"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Stress response due to surgical injury involves activation of inflammatory, endocrine, metabolic and immunologic mediators.1   However, exaggerated activation of various components can result in hemodynamic instability, and metabolic derangement leading to multiple organ failure and mortality.2 The magnitude of response is dependent on the severity, intensity and duration of stimulus. The general response is in the form of wide spread endocrinal, metabolic and biochemical reactions throughout the body using various mediators.3

All the intravenous agents and volatile anaesthetics in normal doses have minor influence on the endocrine and metabolic functions.4 Buyukkocak et al observed similar effect of General anaesthesia (GA) and Spinal Anaesthesia (SA) on stress response.5 Epidural anaesthesia along with general anaesthesia (GA) has shown to affect hormonal and metabolic stress response.6  General anaesthesia, total intravenous anaesthesia (TIVA) and spinal anaesthesia (SA) are also compared for reduction of stress response in laparoscopic cholecystectomy.7  Three different GA regimen and combination have shown different results on stress response.8

None of the studies have seen the effects of combining Peripheral nerve blocks (PNB) with different regimen. Pre-emptive analgesia with PNB is also unexplored. We shall see the effect of combining these different anaesthesia techniques on stress response and inflammatory markers.

 
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