| CTRI Number |
CTRI/2025/04/085595 [Registered on: 24/04/2025] Trial Registered Prospectively |
| Last Modified On: |
22/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Cluster Randomized Trial |
|
Public Title of Study
|
Comparison between Rocuronium bromide and Succinylcholine chloride in Rapid sequence induction and intubation in emergency cases |
|
Scientific Title of Study
|
Rocuronium Bromide versus Succinylcholine Chloride for rapid sequence induction and intubation in emergency cases- a prospective randomized clinical study |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shabiba Yashmin Haque |
| Designation |
Post graduate trainee |
| Affiliation |
Srimanta sankaradeva university of health science |
| Address |
Department of Anaesthesiology and critical care, Gauhati Medical College and Hospital,Bhangagarh, Kamrup (M),
Kamrup
ASSAM
781032
India |
| Phone |
8638160500 |
| Fax |
|
| Email |
shabibay2611@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanchita Sarma |
| Designation |
Associate Professor |
| Affiliation |
Gauhati medical College and hospital |
| Address |
Department of Anaesthesiology and Critical Care, Gauhati Medical College and Hospital, Bhangagarh, Kamrup(M)
Kamrup
ASSAM
781032
India |
| Phone |
9435046228 |
| Fax |
|
| Email |
sbsarma1@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sanchita Sarma |
| Designation |
Associate Professor |
| Affiliation |
Gauhati Medical College and Hospital |
| Address |
Department of Anaesthesiology and Critical Care, Gauhati Medical College and Hospital, Bhangagarh, Kamrup(M)
Kamrup
ASSAM
781032
India |
| Phone |
9435046228 |
| Fax |
|
| Email |
sbsarma1@gmail.com |
|
|
Source of Monetary or Material Support
|
| Gauhati Medical College and Hospital, Kamrup Metro- 781032 |
|
|
Primary Sponsor
|
| Name |
Shabiba Yashmin Haque |
| Address |
Department of Anaesthesiology and Critical Care, Gauhati Medical College and Hospital, Bhangagarh, Kamrup Metro 781032 |
| Type of Sponsor |
Other [Self] |
|
|
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 Shabiba Yashmin Haque |
Gauhati Medical College and Hospital |
Department of Anaesthesiology and Critical Care, Gauhati Medical College and Hospital, Kamrup(M), 781032
Kamrup
ASSAM |
08638160500
shabibay2611@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of Gauhati Medical College and Hospital, Guwahati, 781032 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: K00-K95||Diseases of the digestive system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Availability of informed consent
2.Emergency cases with ASA grading 1,2,3
3.Emergency cases with Mallampati score 1,2,3 |
|
| ExclusionCriteria |
| Details |
1. Non availability of consent
2. Patients with history of allergy to the drugs used in this study
3. Patients with prolonged immobilization, burn or crush injury |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comparision of intubating conditions of succinylcholine chloride and rocuronium bromide during laryngoscopy at 60 seconds |
At 60 seconds of laryngoscopy, the intubating conditions of Rocuronium bromide and Succinylcholine chloride will be compared |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Comparision of adverse effects if any,at the time of laryngoscopy in both the groups-
1.Bradycardia
2.Tachycardia
3.Laryngospasm
4.Arrythmia
5.Others if any |
At baseline, immediately after intubation, At 1 min, 3 min & 5 min of intubation, the adverse effects like bradycardia, tachycardia, laryngospasm, arrythmia will be compared |
|
|
Target Sample Size
|
Total Sample Size="336"
Sample Size from India="336"
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
15/05/2025 |
| 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="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
|
Rocuronium bromide versus Succinylcholine chloride in rapid sequence induction and intubation in emergency cases will be studied in our study. The aim of our study is to compare the ease of intubation of succinylcholine chhloride and rocuronium bromide at 60 seconds for rapid sequence induction and intubation in emergency cases. Primary objective: Comparison of intubating conditions of Succinylcholine chloride and Rocuronium bromide during laryngoscopy at 60 seconds. Secondary objective: Comparison of adverse effects if any, at the time of laryngoscopy in both the groups such as: bradycardia, tachycardia, laryngospasm, arrythmia |