| CTRI Number |
CTRI/2026/03/105690 [Registered on: 09/03/2026] Trial Registered Prospectively |
| Last Modified On: |
06/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of two drugs used for facilitating insertion of the breathing tube and their effects on blood pressure and heart rate in adult patients undergoing surgery |
|
Scientific Title of Study
|
Comparison of intubating condition and hemodynamic responses after administration of succinylcholine and rocuronium 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 Mohitkumar Mardiya |
| Designation |
Third year resident doctor |
| Affiliation |
B.J. Medical college and Civil hospital Ahmedabad |
| Address |
F3 First floor department of anaesthesia civil hospital Asarwa Ahmedabad
NIL
Ahmadabad
GUJARAT
380016
India |
| Phone |
7600318422 |
| Fax |
|
| Email |
mohitmardiya290398@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shakuntala J Goswami |
| Designation |
Professor |
| Affiliation |
B.J. Medical college and Civil hospital Ahmedabad |
| Address |
F3 First floor department of anaesthesia civil hospital Asarwa Ahmedabad
NIL
Ahmadabad
GUJARAT
380016
India |
| Phone |
9327021192 |
| Fax |
|
| Email |
dhrumit09@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shakuntala J Goswami |
| Designation |
Professor |
| Affiliation |
B.J. Medical college and Civil hospital Ahmedabad |
| Address |
F3 First floor department of anaesthesia civil hospital Asarwa Ahmedabad
NIL
Ahmadabad
GUJARAT
380016
India |
| Phone |
9327021192 |
| Fax |
|
| Email |
dhrumit09@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 |
Goverment 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
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Mohitkumar Mardiya |
Civil Hospital Asarwa Ahmedabad |
Major operation theatre Department of general surgery fifth floor new trauma centre building
Ahmadabad
GUJARAT |
7600318422
mohitmardiya290398@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Institutional Ethics Committee 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: 3||Administration, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Intravenous administration of Inj. Rocuronium |
At the time of induction of anesthesia, Inj. Rocuronium 0.8 mg per kg will be given by intravenous route as a single bolus dose. The total duration of this intervention is the single time of administration (approximately 10 to 20 seconds) |
| Comparator Agent |
Intravenous administration of Inj. succinylcholine |
At the time of induction of anesthesia, Inj. Succinylcholine 2mg per kg will be given by intravenous route as a single bolus dose. The total duration of this intervention is the single time of administration (approximately 10 to 20 seconds) |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
ASA Grade I and II
BMI 18-30 kg/m2
Modified Mallampatti Classification I and II Elective surgeries |
|
| ExclusionCriteria |
| Details |
ASA Grade III, IV and V
BMI greater than 30 kg/m2
Modified Mallampatti Classification III and IV
Patient Refusing for Consent |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare intubating conditions as per four point scale of cooper |
60 seconds after the administration of the study drug |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare duration of action of study drugs |
After giving study drug |
| Heart rate, systolic Blood pressure, diastolic blood pressure and mean arterial pressure |
After intubation 1min, 3min, 5min, 10min, 20min, 30min and 1hour. |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
20/03/2026 |
| 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
|
Airway management is a critical component of general anesthesia, requiring rapid and optimal intubating conditions to ensure patient safety and minimize trauma. Succinylcholine has long been considered the gold standard for rapid sequence induction, though it is associated with various side effects. Rocuronium serves as a non-depolarizing alternative that may offer comparable results. This study aims to compare the quality of intubating conditions and the stability of hemodynamic responses following the administration of Succinylcholine versus Rocuronium in adult patients. The goal is to determine if Rocuronium can provide an equally effective clinical environment for intubation while maintaining superior hemodynamic stability. |