| CTRI Number |
CTRI/2023/11/060365 [Registered on: 30/11/2023] Trial Registered Prospectively |
| Last Modified On: |
22/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparing the effects of cisatracurium and rocuronium in intubating a patient rapidly |
|
Scientific Title of Study
|
COMPARISION OF CISATRACURIUM VERSUS ROCURONIUM FOR RAPID SEQUENCE INTUBATION |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prasanna Vadhanan |
| Designation |
Professor |
| Affiliation |
Vinayaka Missions Research Foundation |
| Address |
Department of Anaesthesiology Vinayaka Missions Medical College and Hospital, Keezhakasakudy Medu, Kottucherry post,Karaikal,Puducherry
Karaikal
PONDICHERRY
609609
India |
| Phone |
|
| Fax |
|
| Email |
vadhanan.prasanna@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prasanna Vadhanan |
| Designation |
Professor |
| Affiliation |
Vinayaka Missions Research Foundation |
| Address |
Department of Anaesthesiology Vinayaka Missions Medical College and Hospital, Keezhakasakudy Medu, Kottucherry post,Karaikal,Puducherry
PONDICHERRY
609609
India |
| Phone |
|
| Fax |
|
| Email |
vadhanan.prasanna@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sabana Anjum Bora |
| Designation |
Post Graduate |
| Affiliation |
Vinayaka Missions Research Foundation |
| Address |
No 2 Department of Anaesthesiology First Floor Vinayaka Missions Medical College and Hospital,Keezhakasakudy Medu, Kottucherry post,Karaikal, Puducherry
Karaikal
PONDICHERRY
609609
India |
| Phone |
|
| Fax |
|
| Email |
sabanaanjumbora@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vinayaka Missions Research Foundation,Sankari Main Road,Salem,Tamil Nadu-636308 |
|
|
Primary Sponsor
|
| Name |
Vinayaka Missions Research Foundation |
| Address |
Sankari Main Road (NH-47), Ariyanoor, Salem - 636408 |
| Type of Sponsor |
Private medical college |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Sabana Anjum Bora |
Vinayaka Missions Medical College and Hospital |
Room No:2, Department of Anaesthesiology, Vinayka Missions Medical College and Hospital, Keezhakasakudy Medu, Kotucherry Post, Karaikal
Karaikal
PONDICHERRY |
9654259812
sabanaanjumbora@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
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|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: A09||Infectious gastroenteritis and colitis, unspecified, (2) ICD-10 Condition: H662||Chronic atticoantral suppurative otitis media, (3) ICD-10 Condition: K358||Other and unspecified acute appendicitis, (4) ICD-10 Condition: K469||Unspecified abdominal hernia without obstruction or gangrene, (5) ICD-10 Condition: K806||Calculus of gallbladder and bile duct with cholecystitis, (6) ICD-10 Condition: N634||Unspecified lump in breast, subareolar, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Cisatracurium |
Cisatracurium 0.4 mg/kg(8xED95) has to be given through intravenous route for rapid sequence induction,at 90seconds before intubation. |
| Comparator Agent |
ROCURONIUM |
Rocuronium 0.6 mg/kg to be given intravenously for rapid sequence induction ,at 90 seconds before intubation |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients undergoing elective surgery under general anaesthesia |
|
| ExclusionCriteria |
| Details |
Allergy to drugs
Patients with difficult airway |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Easy passage of the endotracheal tube during intubation with relaxed and abducted view of vocal cords without the patient coughing /bucking during the procedure. |
End of administration of neuromuscular blocker(cisatracurium/rocuronium) to the maximal supression of T1% in assessment of train of four,which will be around 90 seconds from the administration of the drug. |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
1)Mean arterial pressure
2)Heart rate |
Measurements of the heart rate and mean arterial pressure immediately before intubation and 1 minute after tracheal intubation |
|
|
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)
|
15/12/2024 |
| 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="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
After obtaining informed and written consent patient will be divided into two drug groups Group A and Group B each group of 30 subjects. Group A will receive inj.Cisatracurium during the process of rapid sequence intubation while Group B will receive inj.Rocuronium during the same and then the intubation conditons will be assessed along with any adverse events for the drugs, time of intubation and haemodynamic changes including Blood pressure, pulse rate, saturation.
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