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CTRI Number  CTRI/2023/12/060457 [Registered on: 04/12/2023] Trial Registered Prospectively
Last Modified On: 30/11/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Objective versus standard pain management during surgeries 
Scientific Title of Study   qNOX guided versus standard care intraoperative analgesia during fentanyl-propofol anaesthesia in patients undergoing laparoscopic and robotic intraabdominal surgeries- a non inferiority RCT 
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. Manoj Kamal 
Designation  Professor 
Affiliation  All India Institute of Medical Sciences Jodhpur 
Address  All India Institute of Medical Sciences Jodhpur, Cardiothoracic and Vascular Surgery OT Sixth floor D & T Block

Jodhpur
RAJASTHAN
342005
India 
Phone  9414084584  
Fax    
Email  geethamanoj007@yahoo.co.in  
 
Details of Contact Person
Scientific Query  
Name  Dr. Manoj Kamal 
Designation  Professor 
Affiliation  All India Institute of Medical Sciences Jodhpur 
Address  All India Institute of Medical Sciences Jodhpur Cardiothoracic and Vascular Surgery OT Sixth floor D & T Block

Jodhpur
RAJASTHAN
342005
India 
Phone  9414084584  
Fax    
Email  geethamanoj007@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  DR Teena Gupta 
Designation  Junior Resident 
Affiliation  All India Institute of Medical Sciences Jodhpur 
Address  AICU ,department of Anaesthesiology and Critical Care 3rd Floor D&T Block ,AIIMS Jodhpur

Jodhpur
RAJASTHAN
342005
India 
Phone  9910638900  
Fax    
Email  teenagupta99@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences Jodhpur 
 
Primary Sponsor  
Name  All India Institute of Medical Sciences Jodhpur 
Address  Marudhar Industrial Area, 2nd Phase, M.I.A. 1st Phase, Basni, Basni, Jodhpur, Rajasthan 342005 
Type of Sponsor  Research institution and hospital 
 
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 Manoj Kamal  All India Institute of Medical Sciences Jodhpur  D & T OT All India Institute of Medical Sciences Jodhpur, Basni, Jodhpur
Jodhpur
RAJASTHAN 		 9414084584

geethamanoj007@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee AIIMS Jodhpur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: R108||Other abdominal pain,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional intraoperative fentanyl administration  Group B, during induction intravenous fentanyl 2 mics per kg will be given followed by fentanyl boluses 1 mics per kg will be given in response to tachycardia and hypertension or as per discretion of anaesthesiologists. Total intraoperative fentanyl required and post operative PACU and pain scores in the first hour will be compared  
Intervention  qNOX guided intraoperative fentanyl administration  This is a non inferiority RCT. one group will receive q NOX guided fentanyl and other group will receive conventional fentanyl administration. During Induction intravenous fentanyl 2 mics/kg, intravenous fentanyl boluses do 1micskg will be given when qNOX25. Total intraoperative fentanyl required and post operative PACU scores in the first hour will be compared.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Patients of ages 18 years to 70 years of either sex belonging to ASA I to III and Scheduled to undergo elective laparoscopic and robotic intraabdominal surgeries under general anaesthesia expected to last >2 hours 
 
ExclusionCriteria 
Details  i. Patients requiring TIVA for nerve monitoring
ii. Patients who do not have regional or neuraxial blocks
iii. If a different intraoperative opioid than fentanyl is preferred by doctors.
iv. Patients with neurologic conditions who also use psychotropic medications that may make it difficult to accurately estimate postoperative pain
v. Chronic opioid user
vi. BMI > 40 kg/m2
vii. Refusal to give consent
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Comparing the total opioid requirement in intraoperative period and in first hour of post operative period after extubation in patients receiving qNOX-guided fentanyl titration versus those receiving conventional fentanyl administration  Opioid given during intraoperative period; during first 60 min in post op 
 
Secondary Outcome  
Outcome  TimePoints 
i. To compare the pain scores (0-10 Verbal Response Scale) after extubation in patients receiving qNOX guided fentanyl titration versus those receiving conventional fentanyl administration
ii. Time for emergence from anesthesia—the time between the end of inhalational anaesthesia and extubation
iii. Modified Aldrette Score at every 30 minutes
iv. Side effects: like nausea, vomiting,  		 post operative pain scores (VAS) and modified aldrette score in the first hour of post operative period 
 
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   Phase 4 
Date of First Enrollment (India)   11/12/2023 
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 - NO
Brief Summary   The enrolled patients will be randomized by computer-based system into 2 groups – Group A and Group B. In Group A, qNOX guided intraoperative fentanyl boluses will be given, while in Group B, fentanyl boluses will be given in response to tachycardia and hypertension or as per discretion of anaesthesiologists. Comparison of the total opioid requirement in intraoperative period and in first hour of post operative period after extubation in patients receiving qNOX-guided fentanyl titration versus those receiving conventional fentanyl administration will be done. Also the post operative pain scores (0-10 Verbal Response Scale) after extubation in patients receiving qNOX guided fentanyl titration versus those receiving conventional fentanyl administration will be compared along with Modified Aldrette Score at every 30 minutes.  
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