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CTRI Number  CTRI/2024/10/075869 [Registered on: 25/10/2024] Trial Registered Prospectively
Last Modified On: 24/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To study stress response in children undergoing laparoscopic surgery. 
Scientific Title of Study   To study salivary cortisol as a surrogate marker of stress response in children undergoing laparoscopic surgery with low- pressure vs high-pressure pneumoperitoneum : a randomized controlled trial. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
-  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ankur Mandelia 
Designation  Additional Professor 
Affiliation  Sanjay Gandhi Post Graduate Institute of Medical Sciences, Lucknow 
Address  Department Of Pediatric Surgical Superspecialities, PMSSY Block, Sanjay Gandhi Post Graduate Institute of Medical Sciences, Lucknow

Lucknow
UTTAR PRADESH
226014
India 
Phone  8004967729  
Fax    
Email  drankurmandelia@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Nishant Agarwal  
Designation  Senior Resident 
Affiliation  Sanjay Gandhi Post Graduate Institute of Medical Sciences, Lucknow 
Address  Department Of Pediatric Surgical Superspecialities, PMSSY Block, Sanjay Gandhi Post Graduate Institute of Medical Sciences, Lucknow

Lucknow
UTTAR PRADESH
Dr Nishant Agarwal
India 
Phone  09458705175  
Fax    
Email  nishantagarwal22121993@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Nishant Agarwal 
Designation  Senior Resident 
Affiliation  Sanjay Gandhi Post Graduate Institute of Medical Sciences, Lucknow 
Address  Department Of Pediatric Surgical Superspecialities, PMSSY Block, Sanjay Gandhi Post Graduate Institute of Medical Sciences, Lucknow

Lucknow
UTTAR PRADESH
Dr Nishant Agarwal
India 
Phone  09458705175  
Fax    
Email  nishantagarwal22121993@gmail.com  
 
Source of Monetary or Material Support  
Intramural Research Grant, Sanjay Gandhi Post Graduate Institute of Medical Sciences, Lucknow, India. Pincode : 226014 
 
Primary Sponsor  
Name  Intramural research grant 
Address  Sanjay Gandhi Post Graduate Institute of Medical Sciences, Lucknow, India . Pincode : 226014 
Type of Sponsor  Research institution 
 
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 Nishant Agarwal  Sanjay Gandhi Post Graduate Institute of Medical Sciences  Department Of Pediatric Surgical Superspecialities, 2nd floor PMSSY Block, Sanjay Gandhi Post Graduate Institute of Medical Sciences, Lucknow Pin : 226014
Lucknow
UTTAR PRADESH 		 9458705175

nishantagarwal22121993@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Sanjay Gandhi Post Graduate Institute of Medical Sciences  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K802||Calculus of gallbladder without cholecystitis, (2) ICD-10 Condition: Q00-Q99||Congenital malformations, deformations and chromosomal abnormalities, (3) ICD-10 Condition: K00-K95||Diseases of the digestive system, (4) ICD-10 Condition: N00-N99||Diseases of the genitourinary system, (5) ICD-10 Condition: S00-T88||Injury, poisoning and certain other consequences of external causes,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  12.00 Month(s)
Age To  12.00 Year(s)
Gender  Both 
Details  Children aged 1-12 years undergoing laparoscopic surgery  
 
ExclusionCriteria 
Details  Children with underlying adrenal pathologies e.g. adrenal tumors, congenital adrenal hyperplasia (CAH), etc.

Children on steroid therapy

Children undergoing laparoscopic surgery for acute inflammatory conditions like appendicitis, Meckel’s diverticultis etc.

Refusal of parental consent for participation in the study  
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The primary outcome measures are pre-operative and post-operative salivary cortisol levels in the two study groups.   Pre-operatively. at 6 hours post surgery, at 12 hours post surgery, at 24 hours post surgery, at 48 hours post surgery, at 72 hours post surgery. 
 
Secondary Outcome  
Outcome  TimePoints 
Secondary outcome measures are HR, MAP, EtCO2 during surgery at different time points as mentioned earlier, duration of the surgery, length of hospital stay, time to resume feeds, post-operative pain & analgesia requirement  HR, MAP AND EtCO2 will be recorded, before CO2 insufflation (T0), 20 min after insufflation (T1), before desufflation (T2), & 10 min after desufflation (T3)
Pain will be assessed at POD-1 & POD-2 
 
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   Phase 3 
Date of First Enrollment (India)   05/11/2024 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  

Aims & Objectives:  

  

To determine the stress response in children undergoing laparoscopic surgery with low- pressure vs high-pressure pneumoperitoneum (PP). 

Materials and methods:  

Study design: Prospective, randomized, single blind, observational study   

  

Study site: SGPGIMS, Lucknow  

  

Study duration: 12 months  

  

Study population  

  

Inclusion criteria:   

  • Children aged 1-12 years undergoing laparoscopic surgery  

 

Exclusion criteria:   

  • Children with underlying adrenal pathologies e.g. adrenal tumors, congenital adrenal hyperplasia etc.   

  • Children on steroid therapy   

  • Children undergoing laparoscopic surgery for acute inflammatory conditions like appendicitis, Meckel’s diverticultis etc.   

  • Refusal of parental consent for participation in the study  

 

  

Description of interventions:  

Patients will be randomized to either low-pressure PP group (group I) or high-pressure PP group (group II).   

Heart rate (HR), non-invasive mean arterial blood pressure (MAP) and end tidal CO2 (EtCO2) will be measured at four points: before CO2 insufflation (T0), 20 min after insufflation (T1), before desufflation (T2), and 10 min after desufflation (T3).   

  Duration of anaesthesia and surgery, duration of hospital stay, time to resume feeding, post-operative pain and analgesia requirement will be recorded.  

  

Saliva collection and preparation  

Saliva shall be collected from each study participant pre-operatively and at 6, 12, 24, 48 and 72 hrs post-operatively. Sample will be refrigerated at 4oC within 30 minutes and then frozen at or below -20°C within 12 hours after collection.   

  

 Salivary cortisol measurement methods  

Salivary cortisol shall be measured by commercially available ELISA kits  

  

Outcome measures  

The primary outcome measures are pre-operative and post-operative salivary cortisol levels in the two study groups.   

Secondary outcome measures are HR, MAP, EtCO2 during surgery at different time points as mentioned earlier, duration of the surgery, length of hospital stay, time to resume feeds, post-operative pain and analgesia requirement.  

  

Analysis plan:  

Statistical analysis to be performed using software “Statistical package for social sciences version 23 (SPSS-23) and MedCalc.    

 

Key words (at least 5): pediatric; laparoscopy; stress response; salivary cortisol; pneumoperitoneum; low-pressure; high-pressure 

 
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