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CTRI Number  CTRI/2025/12/099243 [Registered on: 16/12/2025] Trial Registered Prospectively
Last Modified On: 16/12/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   A study comparing the effect of priming of rocuronium on the speed and ease of intubation in adult patients. 
Scientific Title of Study   A Randomised trial to compare the onset time and intubating conditions using Rocuronium with or without priming in adult patients. 
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 CHITRA NILESH DARJI 
Designation  second year resident doctor 
Affiliation  B.J. MEDICAL COLLEGE AND CIVIL HOSPITAL 
Address  F3 FIRST FLOOR DEPARTMENT OF ANAESTHESIA CIVIL HOSPITAL ASARWA AHMEDABAD
NIL
Ahmadabad
GUJARAT
380016
India 
Phone  8200616053  
Fax    
Email  chitrandarji@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr SMITA R ENGINEER 
Designation  Professor and head 
Affiliation  B.J. MEDICAL COLLEGE AND CIVIL HOSPITAL 
Address  F3 FIRST FLOOR DEPARTMENT OF ANAESTHESIA CIVIL HOSPITAL ASARWA AHMEDABAD

Ahmadabad
GUJARAT
380016
India 
Phone  9825504948  
Fax    
Email  seng_90@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr SMITA R ENGINEER 
Designation  Professor and head 
Affiliation  B.J. MEDICAL COLLEGE AND CIVIL HOSPITAL 
Address  F3 FIRST FLOOR DEPARTMENT OF ANAESTHESIA CIVIL HOSPITAL ASARWA AHMEDABAD

Ahmadabad
GUJARAT
380016
India 
Phone  9825504948  
Fax    
Email  seng_90@yahoo.com  
 
Source of Monetary or Material Support  
Government of Gujarat Health and family welfare department 7th floor new sachivalaya Gandhinagar 382010 Gujarat India 
 
Primary Sponsor  
Name  Government of Gujarat 
Address  Health and family welfare department 7th floor new sachivalaya Gandhinagar 382010 Gujarat India 
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 
Dr CHITRA NILESH DARJI  Civil Hospital, B J medical college ,Ahmedabad  5th floor surgery operation theatre, trauma center building
Ahmadabad
GUJARAT 		 8200616053

chitrandarji@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
The Institutional Ethics Committee B. J. Medical College & Civil Hospital, Ahmedabad  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  priming with normal saline  Priming dose of normal saline will be given 3 min before the intubating of Rocuronium bromide (0.6mg/kg ) 
Intervention  priming with rocuronium  the priming dose of rocuronium bromide 0.06 mg/kg (10% of intubating dose) will be given 3 min before the intubating dose followed by 0.54mg/kg intubating dose.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1)Patients willing to consent for the study.
2)American Society of Anesthesiologist (ASA) Classification I, II, III 
 
ExclusionCriteria 
Details  1)Patients with neuromuscular diseases
2)anticipated difficult intubation (obesity, thyromental distance more than 6 cm and Mallampati grade 3 and 4)
3)pregnancy
4)hepatic, renal diseases
5)patients receiving drugs interfering with neuromuscular action
6) Patient refusal
7)ASA IV and V 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare onset time of intubation and intubating conditions using Cooper Scoring system.  Time interval between the intubating dose and the loss of T1 of TOF stimuli will be considered as “onset time of intubation.” 
 
Secondary Outcome  
Outcome  TimePoints 
To compare hemodynamic parameters and complications  duration of surgery 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   01/01/2027 
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 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  

Muscle relaxants are used during intubation and surgery to reduce the need for anesthesia and facilitate intubation. 

Due to its rapid onset, short duration of action and profound muscle relaxation, succinylcholine (Depolarizing Muscle Relaxant) is used for rapid sequence induction and endotracheal intubation.

But, succinylcholine has a number of undesirable side-effects like muscle fasciculations, myalgia, hyperkalemia, bradyarrhythmia, increased intra-ocular, intracranial and intragastric pressure, malignant hyperthermia and masseter spasm.Due to these undesirable side-effects especially in patients having neuromuscular disorders, burns, acute head injury, open eye injury, spinal cord injury, cerebrovascular accidents and renal diseases, succinylcholine is not suitable.

Newer techniques using NDMR (Non-Depolarizing Muscle Relaxants) have evolved for rapid and smooth induction. Rocuronium is an NDMR. It produces faster neuromuscular blockade compared to other neuromuscular blocking drugs. It produces comparable intubating conditions to that of succinylcholine. When rocuronium is used with priming technique, it can be considered as an alternate to succinylcholine.

In priming principle, a divided dose technique of neuromuscular blocking drug is given which is capable of producing a rapid onset of neuromuscular block and suitable intubating conditions. A small priming dose(10% of NDMR)which will not cause any unpleasant side effects is used. It occupies 75% of end plate receptors. After 2–4 min, the rest of the intubating dose of the drug is administered to produce suitable conditions for endotracheal intubation.

This study is planned to evaluate and compare the effect of priming principle using rocuronium bromide on onset time of intubation and intubating conditions (using TOF monitoring).

This study is based on the hypothesis that priming with rocuronium may fasten the onset time compared to rocuronium without priming for endotracheal intubation.

 
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