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CTRI Number  CTRI/2025/12/098715 [Registered on: 10/12/2025] Trial Registered Prospectively
Last Modified On: 09/12/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparison of intubating conditions with combination of Fentanyl-Lidocaine-Propofol versus Fentanyl-Dexmedetomidine-Propofol in absence of neuromuscular blocking agent  
Scientific Title of Study   Comparison of intubating conditions with combination of Fentanyl-Lidocaine-Propofol versus Fentanyl-Dexmedetomidine-Propofol in absence of neuromuscular blocking agent  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
Nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sripriya 
Designation  Junior Resident 
Affiliation  Grant government medical college and JJ hospital 
Address  Department of Anaesthesiology 6th floor, Main building Grant government medical college and JJ hospital Mohammed Ali road Mazgaon

Mumbai
MAHARASHTRA
400008
India 
Phone  7624840564  
Fax    
Email  sripriyak99@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Veena Ganeriwal 
Designation  Associate Professor  
Affiliation  Grant government medical college and JJ hospital 
Address  Department of Anaesthesiology Grant government medical college and JJ hospital Mohammed Ali road Mazgaon

Mumbai
MAHARASHTRA
400008
India 
Phone  9821300699  
Fax    
Email  veenaganeriwal@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Veena Ganeriwal 
Designation  Associate Professor  
Affiliation  Grant government medical college and JJ hospital 
Address  Department of Anaesthesiology Grant government medical college and JJ hospital Mohammed Ali road Mazgaon


MAHARASHTRA
400008
India 
Phone  9821300699  
Fax    
Email  veenaganeriwal@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesiology Grant Govt Medical College Mohammed Ali Road Mazgaon Mumbai India 400008 
 
Primary Sponsor  
Name  Dr Sripriya  
Address  Department of Anaesthesiology Grant Govt Medical College Mohammed Ali Road Mazgaon Mumbai India 400008 
Type of Sponsor  Other [Self ] 
 
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 Sripriya K  Institutional Ethics Committee  Department of Anaesthesiology main building 6th floor Grant government medical college and JJ group of hospitals Mohammed Ali raod Mazgaon
Mumbai
MAHARASHTRA 		 7624840564

sripriyak99@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committe Grant government medical college  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J958||Other intraoperative and postprocedural complications and disorders of respiratory system, not elsewhere classified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Fentanyl-Dexmedetomidine-Propofol  A combination of fentanyl 2 mcg/kg, dexmedetomidine 0.8 mcg/kg, and propofol 2 mg/kg given for induction to evaluate its effectiveness in providing superior intubating conditions and hemodynamic stability without neuromuscular blocking agents.  
Comparator Agent  Fentanyl-Lidocaine-Propofol  A combination of fentanyl 2 mcg/kg, lidocaine 2 mg/kg, and propofol 2 mg/kg used as an active control to assess standard intubating conditions and hemodynamic response during intubation without neuromuscular blockers. 
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  ASA grade I and II
Patients undergoing elective surgeries under general anaesthesia
Patient willing to give written informed consent
 
 
ExclusionCriteria 
Details  Patients with history of reactive airway disease, oesophageal reflux , previous difficulty with intubation or a suspected difficult airway.
Patients with allergy to any of the study drugs.
Patients with pre-existing cardiovascular, renal and hepatic disorders.
Surgical procedures which lasts more than 4 hrs will be excluded from the study.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Comparing intubating conditions in combination of fentanyl-dexmedetomidine-propofol with fentanyl-lidocaine-propofol in absence of neuromuscular relaxant   Comparing intubating conditions during intubation and every 1 min for 5 minutes post intubation 
 
Secondary Outcome  
Outcome  TimePoints 
Nil   Nil  
 
Target Sample Size   Total Sample Size="56"
Sample Size from India="56" 
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)   21/12/2025 
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="0"
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   This prospective randomized comparative study aims to evaluate whether the combination of Fentanyl–Dexmedetomidine–Propofol provides superior intubating conditions compared to Fentanyl–Lidocaine–Propofol during endotracheal intubation without neuromuscular blocking agents in ASA I–II adults aged 18–60 years undergoing elective surgery under general anesthesia. A total of 56 patients will be randomized into two groups, receiving either fentanyl with lidocaine or fentanyl with dexmedetomidine prior to induction with propofol, and intubating conditions will be assessed using the Viby–Mogensen scoring system along with monitoring hemodynamic responses for 5 minutes post-intubation. The study seeks to determine which drug combination better suppresses airway reflexes, provides smoother intubation, and maintains greater hemodynamic stability, while also observing any adverse events and the need for rescue muscle relaxants. The findings aim to guide safe and effective intubation practices when neuromuscular blockers are contraindicated or undesirable. 
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