| CTRI Number |
CTRI/2025/05/086525 [Registered on: 07/05/2025] Trial Registered Prospectively |
| Last Modified On: |
22/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparing the effectiveness of two drugs (neuromuscular blocking agents) during a life saving procedure (intubation) |
|
Scientific Title of Study
|
Succinylcholine versus Rocuronium for rapid sequence intubation:A randomized open labelled study |
| Trial Acronym |
SVSR |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Arun K |
| Designation |
Junior resident |
| Affiliation |
AIIMS New Delhi |
| Address |
Department of Emergency Medicine,Ansari Nagar,AIIMS New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9562119558 |
| Fax |
|
| Email |
arunraghavkunnath@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nayer Jamshed |
| Designation |
Additional Professor |
| Affiliation |
AIIMS New Delhi |
| Address |
Department of Emergency Medicine,Ansari Nagar,AIIMS New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9990345682 |
| Fax |
|
| Email |
jamshednayer@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nayer Jamshed |
| Designation |
Additional Professor |
| Affiliation |
AIIMS New Delhi |
| Address |
Department of Emergency Medicine,Ansari Nagar,AIIMS New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9990345682 |
| Fax |
|
| Email |
jamshednayer@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences,New Delhi,Delhi-110029 |
|
|
Primary Sponsor
|
| Name |
Department of Emergency MedicineAIIMS New Delhi |
| Address |
AIIMS, New Delhi, Delhi-110029 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| DrArun K |
AIl India Institute of Medical Sciences, New Delhi |
Department of Emergency Medicine,Ansari Nagar,AIIMS New Delhi 110029
New Delhi
DELHI |
9562119558
arunraghavkunnath@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee for biomedical and health research |
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 |
Rocuronium |
Inj.Rocuronium is given intravenously as bolus at 1.2 mg/kg, with intubation level paralysis occuring 45 to 60 seconds |
| Intervention |
Succinylcholine |
Inj.Succinylcholine is given intravenously as bolus at 1mg/kg, with intubation level paralysis occuring 45 to 60 seconds |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Adults of 18 years and above requiring Rapid sequence Intubation ,their legally authorised representative willing to give a valid consent |
|
| ExclusionCriteria |
| Details |
Legally authorized representative unable or
unwilling to give informed consent,
Patients less than 18 years of age,
Patients with history of cardiac arrest,
Patients allergic to succinylcholine or rocuronium
Pregnancy,
Preexisting myopathies or myasthenia gravis,
Preexisting hyperkalemia,
Patients with massive edema, immobile jaw from
injury or infection,
Patients with oropharyngeal tumors |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the success rate of first-attempt orotracheal intubation in patients
receiving succinylcholine versus rocuronium assessed by the physician and
confirmed by capnography curve consistent over 3 respiratory cycles. |
To compare the success rate of first-attempt orotracheal intubation in patients
receiving succinylcholine versus rocuronium assessed by the physician and
confirmed by monitoring capnography curve over 12 to 15 seconds (consistent over 3 respiratory cycles) as per ventilator settings of Respiratory rate in a range of 12 to 16 breaths per minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare
1.Intubation condition assessed by Copenhagen score
2.Percentage of patients intubated by alternative techniques
3.Intubation related complication in fifteen minutes
Cardiac arrest, Arterial hypotension less than ninty mm Hg,Occurrence of new oxygen desaturation,Physician reported aspiration, Arrhythmia, Allergic reaction |
1.Copenhagen score calculated at 45 to 60 seconds after administration of neuromuscular blocking agents
2.Alternative techniques of intubation will be used after failure of 3rd attempt of orotracheal intubation.
3.Intubation related complication such as Cardiac arrest, Arterial hypotension less than 90 mmHg,Occurrence of new oxygen desaturation,Physician reported aspiration, Arrhythmia, Allergic reaction are assessed within 15 minutes of post intubation |
|
|
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)
|
20/05/2025 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
This is a prospective open labelled randomised control trial of parallel group to compare the success rate of first attempt orotracheal intubation and effects of intravenous Succinylcholine versus Rocuronium in rapid sequence intubation.Patients aged 18 and more are recruited after taking into consideration of inclusion and exclusion criteria with their legally authorised respresentative giving a valid consent, are randomised into two groups- Group S receiving intravenous Succinylcholine as bolus at 1mg/kg and Group-R receiving intravenous Rocuronium as bolus at 1.2 mg/kg. Primary objective is to compare the success rate of first attempt orotracheal intubation in patient receiving Succinylcholine versus Rocuronium, assessed by physician and confirmed by capnography curve consistent over three respiratory cycles.Secondary objective is to evaluate the intuabtion condition by Copenhagen score and percentage of patients intuabted by other techniques along with the complications seen with the use of either drugs in the first 15 minutes post successful orotracheal intubation. |