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CTRI Number  CTRI/2026/01/100370 [Registered on: 05/01/2026] Trial Registered Prospectively
Last Modified On: 04/01/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   “A study in patients undergoing surgery comparing two doses of a muscle-relaxing medicine to see which allows easier placement of a breathing tube.” 
Scientific Title of Study   A comparative study of intubating conditions with two different doses of cisatracurium besylate in patients undergoing 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  Dr Umesh B Jadav 
Designation  Resident Doctor Anesthesiology 
Affiliation  B. J. Medical College , Ahmedabad 
Address  Dariyala Mandir Pase , Narsipara , Dhrangadhra ,Surendranagar ,Gujarat
b.j.medical college and civil hospital,asarwa, Ahmedabad
Ahmadabad
GUJARAT
363310
India 
Phone  8460883493  
Fax    
Email  jadavumesh1402@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Siddharth B Parmar 
Designation  Associate Proffesor 
Affiliation  B. J. Medical College , Ahmedabad 
Address  F3 department of Anesthesiology, B.J. Medical College And civil Hospital , Asarwa , Ahmedabad

Ahmadabad
GUJARAT
380016
India 
Phone  9426332701  
Fax    
Email  drsid25@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Siddharth B Parmar 
Designation  Associate Proffesor 
Affiliation  B. J. Medical College , Ahmedabad 
Address  F3 department of Anesthesiology, B.J. Medical College And civil Hospital , Asarwa , Ahmedabad


GUJARAT
380016
India 
Phone  9426332701  
Fax    
Email  drsid25@gmail.com  
 
Source of Monetary or Material Support  
Nil 
 
Primary Sponsor  
Name  BJ Medical College Ahmedabad 
Address  BJ medical college and civil hospital , asarwa , ahmedabad -380016 
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 
Jadav umesh  BJ Medical College And Civil Hospital Ahmedabad  This study was conducted in the Department of Anesthesiology, F3 block 1st floor trauama centre, B.J. Medical College and Civil Hospital, Ahmedabad, Gujarat.
Ahmadabad
GUJARAT 
8460883493

jadavumesh1402@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics of Committee (for Academic Studies) B.J.Medical College and 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  Cisatracurium Besylate 0.15 mg/kg   “Cisatracurium besylate 0.15 mg/kg is administered as an intravenous bolus during induction of general anaesthesia to facilitate endotracheal intubation. A fixed waiting period of 180 seconds (3 minutes) will be observed before intubation is attempted. The total duration of intervention is recorded as the time from drug administration to successful endotracheal intubation 
Intervention  Cisatracurium Besylate 0.20 mg/kg  “Cisatracurium besylate 0.2 mg/kg is administered as an intravenous bolus during induction of general anaesthesia to facilitate endotracheal intubation. A fixed waiting period of 180 seconds (3 minutes) will be observed before intubation is attempted. The total duration of intervention is recorded as the time from drug administration to successful endotracheal intubation 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  Patients in ASA I and II
Patients who have signed a Valid Informed written consent.
Patients posted for elective surgery under general anesthesia requiring endotracheal intubation.
Surgeries with estimated duration of 45 minutes to 3 hours. 
 
ExclusionCriteria 
Details  Patient refusing for consent.
Patients with known and anticipated difficult airway (MPC III or IV)
Patients with history of Asthma.
Patients on antihistamine and anticonvulsants.
Patients with history suggestive of sleep apnea. . Patients with history of Gastro Esophageal Reflex Disease. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Quality of intubating conditions after administration of two different doses of cisatracurium (0.15 mg/kg vs 0.20 mg/kg) for endotracheal intubation  Assessed after 180 seconds of cisatracurium administration, at the time of intubation. 
 
Secondary Outcome  
Outcome  TimePoints 
Secondary outcomes included intraoperative hemodynamics (HR, SBP, DBP, MAP) at defined time points and perioperative/postoperative adverse effects (allergic reactions, bronchospasm, hypotension, prolonged muscle weakness, residual paralysis).
 
before intubation, during laryngoscopy, 1,5,10, 20,30,40,50,60,90,120,180 minutes and postoperative 24 hr. 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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)   25/01/2026 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  25/01/2026 
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [jadavumesh1402@gmail.com].

  6. For how long will this data be available start date provided 26-09-2025 and end date provided 01-12-2031?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

General anesthesia is essential for facilitating surgeries by ensuring patient unconsciousness, analgesia, and often muscle relaxation. Endotracheal intubation is an essential component of general anesthesia, providing a secure airway and enabling controlled ventilation during surgery. Optimal intubating conditions are crucial for minimizing airway trauma, hemodynamic disturbances, and patient discomfort. Muscle relaxants play a vital role in achieving these conditions.

Succinylcholine, a depolarizing neuromuscular blocker, has traditionally been the drug of choice due to its rapid onset and short duration. However, its significant side effects—including hyperkalemia, malignant hyperthermia, increased intraocular pressure, and bradyarrhythmias—limit its use in certain patient populations. This has led to a shift toward safer non-depolarizing agents like atracurium and cisatracurium besylate.

Although atracurium is effective, its potential to cause histamine release—resulting in adverse effects such as hypotension, tachycardia, and bronchospasm—has the need for safer alternatives like cisatracurium in clinical practice.

Cisatracurium is a stereoisomer of atracurium, known for its intermediate duration of action, minimal histamine release, and organ-independent metabolism via Hofmann elimination. It is 3–4 times more potent than atracurium and demonstrates a favorable hemodynamic profile, even at higher doses. These properties make it suitable for use in patients with hepatic or renal dysfunction. The ideal dose of cisatracurium for intubation remains under evaluation, balancing between achieving optimal intubating conditions and minimizing residual neuromuscular blockade.

While the standard intubating dose is generally considered to be 2×ED95 (0.1 mg/kg), higher doses such as 0.15 mg/kg and 0.2 mg/kg have been suggested to improve intubation conditions without significantly prolonging recovery. However, comparative data between these two dosing strategies is limited. 

This study is designed to evaluate and compare the intubating conditions, hemodynamic responses, and potential adverse effects of two different doses of cisatracurium besylate—0.15 mg/kg and 0.2 mg/kg—in patients undergoing general anesthesia. The results will help optimize dosing strategies for improved patient outcomes and safer anesthetic practice.


 
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