| 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
|
|
|
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
|
|
|
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
|
|
|
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
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Informed Consent Form Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [jadavumesh1402@gmail.com].
- 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.
- 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. |