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CTRI Number  CTRI/2025/07/091536 [Registered on: 23/07/2025] Trial Registered Prospectively
Last Modified On: 23/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of surgical pleth index guided analgesia with conventional analgesia practice for total fentanyl consumption in children undergoing urethroplasty .  
Scientific Title of Study   Comparison of surgical pleth index guided analgesia with conventional analgesia practice for total fentanyl consumption in children undergoing urethroplasty under general anaesthesia. 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Neha Yadav 
Designation  Post graduate student  
Affiliation  ABVIMS and Dr. Ram Manohar Lohia Hospital,New delhi 
Address  Room no A1114 New doctors hostel ABVIMS and Dr. Ram Manohar Lohia hospital New Delhi

New Delhi
DELHI
110001
India 
Phone  7427040698  
Fax    
Email  drneha174@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Nisha Kachru 
Designation  Director Professor  
Affiliation  ABVIMS and Dr. Ram Manohar Lohia Hospital,New Delhi  
Address  Room no 305 Academic wing ,PGI building ABVIMS and Dr. Ram Manohar Lohia Hospital,New Delhi

New Delhi
DELHI
110001
India 
Phone  9810488435  
Fax    
Email  nishakachru@yahoo.co.uk  
 
Details of Contact Person
Public Query
 
Name  Nisha Kachru 
Designation  Director Professor  
Affiliation  ABVIMS and Dr. Ram Manohar Lohia Hospital,New Delhi  
Address  Room no 305 Academic wing ,PGI building ABVIMS and Dr. Ram Manohar Lohia Hospital,New Delhi

New Delhi
DELHI
110001
India 
Phone  9810488435  
Fax    
Email  nishakachru@yahoo.co.uk  
 
Source of Monetary or Material Support  
ABVIMS and Dr. Ram Manohar Lohia Hospital Baba Kharak Singh Marg, near Gurudwara Bangla Sahib, Connaught Place, New Delhi 110001 
 
Primary Sponsor  
Name  Department of Anaesthesia  
Address  ABVIMS and Dr. Ram Manohar Lohia Hospital,New Delhi 
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 
Neha Yadav  ABVIMS and Dr. Ram Manohar Lohia Hospital   Department of Anaesthesia,ABVIMS and Dr. Ram Manohar Lohia Hospital, New Delhi
New Delhi
DELHI 
7427040698

drneha174@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee,ABVIMS and Dr. Ram Manohar Lohia Hospital,New Delhi   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N359||Urethral stricture, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional analgesia practice   Comparison of surgical pleth index guided analgesia with conventional analgesia practice for total fentanyl consumption in children undergoing urethroplasty . 
Comparator Agent  Surgical pleth index   Comparison of surgical pleth index guided analgesia with conventional analgesia practice for total fentanyl consumption in children undergoing urethroplasty. 
 
Inclusion Criteria  
Age From  3.00 Year(s)
Age To  8.00 Year(s)
Gender  Both 
Details  1. ASA class I and II
2. Children undergoing urethroplasty under general anaesthesia. 
 
ExclusionCriteria 
Details  1. Children with prematurity and developmental delays.
2. Allergy to any drug. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Total amount of fentanyl consumed intraoperatively in both the groups   At baseline followed by every 10 min interval till the removal of proseal LMA 
 
Secondary Outcome  
Outcome  TimePoints 
1) Total amount of sevoflurane consumed in both the groups.
2)Time for emergence from anaesthesia taken as the time from discontinuation of anaesthesia to removal of proseal LMA in both the groups
3) Incidence of postoperative agitation and sedation using Richmond Agitation Sedation Scale in both the groups.
4) Immediate postoperative pain in both the groups using modified CHEOPS Scale. 
At baseline in Immediate postoperative period followed by every 10 min till 30 mins. 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   04/08/2025 
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="4"
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   After obtaining Institutional Ethics Committee approval and written informed consent from the guardians, paediatrics patients aged 3 years to 8 years with American Society of Anaesthesiologists (ASA) grade I and II undergoing urethroplasty under general anaesthesia will be enrolled for the study. The patients will be kept fasting 6 hours for formula feeds and
solids, 4 hours for breast milk and 2 hours for clear fluids prior to the surgery. Upon arrival in the operating room, standard ASA preinduction monitors such as electrocardiograph (ECG),
non-invasive blood pressure, pulse oximeter, and temperature monitoring along with surgical pleth index and entropy monitoring will be attached and the baseline readings will be noted.
All the children will be induced with sevoflurane, oxygen and nitrous oxide. I.V. cannula will be secured, and Ringer’s lactate will be started according to the body weight using Holliday
Segar formula.
All the patients will receive inj. Fentanyl 2mcg/kg. Inj. Propofol 1mg/kg if required and inj. Atracurium 0.5mg/kg for muscle relaxation. Muscle relaxation will be maintained with inj.
Atracurium 0.1 mg/kg given at every 20 minutes interval. Airway will be secured using proseal LMA of appropriate size. Ventilation will be maintained at a tidal volume of 8 to 10 mL/kg
and frequency adjusted to maintain an end tidal carbon dioxide between 30 to 35 mmHg. Anaesthesia will be maintained and adjusted with sevoflurane in air and oxygen mixture
(50:50) to achieve a state entropy between 40 and 60.
In the intraoperative period, further administration of analgesia will be given according to the group of the patient.
Group A (control group) patients will receive Inj Fentanyl 0.5mcg/kg. whenever there is an increase in the mean arterial pressure or heart rate by 20% above the baseline values.
Group B (SPI guided group) Inj fentanyl 0.5mcg/kg will be given whenever there is an increase in SPI values >40 or a rapid increase în SPI by 10.
Mean arterial pressure, heart rate and SPI will be recorded every 10 minutes.
All children will receive paracetamol in a dosage of 15 mg/kg body weight intravenously prior to the end of surgery for postoperative analgesia. At the end of the surgery, all anaesthetic agents will be discontinued, and residual neuromuscular blockade reversed with neostigmine (0.5mg/kg) and glycopyrrolate (0.1mg/kg) and the proseal LMA will be removed after return of spontaneous ventilation with eye opening and sufficient recovery of muscular strength.
Emergence time will be measured from the time of discontinuation of anaesthetic agents to removal of proseal LMA. At the end of the surgery total opioid and sevoflurane consumption
will be noted.
In the recovery room, postoperative sedation and agitation will be graded using Richmond Agitation and Sedation Scale (RASS). And postoperative pain score will be determined using
the modified Children’s Hospital of Eastern Ontario Pain Scale (CHEOPS). If CHEOPS Score > 4, patients will receive additional top ups of Inj Fentanyl 0.25mcg/kg.
Any drop in oxygen saturation <95% will be recorded and treated with application of an oxygen mask and encouraging breathing.
 
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