| 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
|
|
|
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
|
|
|
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. |